This document discusses clinical research and clinical trials conducted by clinical research organizations (CROs). It provides an executive summary of CRO activities, including that CROs conduct over 9,000 clinical trials annually in 142 countries involving 1.4 million patients. The purpose is to bring new medicines to market efficiently and safely. CROs pursue innovation to meet industry demands and help patients access new treatments. The document outlines CRO contributions to clinical research and innovations that help make trials more efficient, such as using data analytics and adaptive trial designs. It recommends policies to further support clinical research innovations.
This document discusses strategies and best practices for adopting medical technology. It emphasizes the importance of health technology assessment (HTA) and knowledge translation (KT) in facilitating evidence-informed decision making. Key challenges include gaps between research evidence and clinical practice. Strategies proposed include creating timely evidence reviews, using frameworks like Know4Go to evaluate technologies based on criteria like effectiveness and costs, and developing institutional capacity for HTA-informed decisions. Local contextualization, collaboration, training, and clinician champions are seen as important for successful technology adoption.
The Business of Genomic Testing by James CrawfordKnome_Inc
This document summarizes the key findings from a survey of 13 early adopter institutions that have implemented next-generation genomic sequencing (NGS) technologies. The survey identified common drivers for adoption including demands from clinical colleagues, anticipated efficiency gains, and acquiring institutional expertise. It also explored barriers such as lack of informatics expertise and high costs. Respondents provided lessons learned such as NGS being more complicated than expected and the importance of multidisciplinary teams. Common measures of successful outcomes included growth in test volumes and expansion of testing menus. The document concludes with recommendations for professional organizations like the College of American Pathologists, including providing educational programs and testing standards.
Sense of urgency, lessons learned, organizational alignment, team approach, training and an increasing engineering and statistical capability at CDER FDA can be expected to facilitate a move by industry towards continues manufacturing, FDA’s current emphasis on ‘statistical confidence’, Process Validation Guidance 2011, is likely to highlight certain issues (e.g., special causes) within current batch processing; these observation will need to be addressed in an appropriate risk-based manner
Ensuring that pragmatic consideration for specifications & control (intended use) is essential and importance of pragmatic decisions should not be forgotten (e.g., as in case of Design Space Vs. SUPAC), Effective regulatory communication (considering the engineering and statistical emphasis) will be crucial for ensuring regulatory uncertainty is managed in a timely manner,
Cancer Cachexia Global Clinical Trials Review, H1, 2013ReportLinker.com
Cancer Cachexia Global Clinical Trials Review, H1, 2013
Summary
GlobalData's clinical trial report, 'Cancer Cachexia Global Clinical Trials Review, H1, 2013" provides data on the Cancer Cachexia clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Cancer Cachexia. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Cancer Cachexia. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
CHIR Best Brains Exchange 22 January 2016Ajaz Hussain
Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada?
What regulatory, policy, and/ or governance changes are needed to address new and increased risks?
How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies?
Visioning the Next Decade: NIPTE-FDA CollaborationAjaz Hussain
NIPTE Seminar at US FDA, 16 March 2016.
QBR as an Organizing Principle for the Proposed NIPTE Center of Excellence for Pharmaceutical Formulations (CEPF)
We are defining the problem too narrowly. Our paradigm of pharmaceutical quality sifted long-ago. We have harmonized on a regulatory methodology for QbD (e.g., ICH Q8). However, with the prevailing ontological gaps (for example as illustrated in the continuing challenges posed with the current FDA’s Inactive Ingredient Database) - How good are the scientific explanations in regulatory submissions? Is quality risk-assessment - metaphysical or an epistemological category?
This document discusses current and future innovation in the pharmaceutical industry from the perspective of Merck Research Laboratories. It outlines Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. Statistics are provided on Merck's 2018 clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams. Considerations for clinical trial planning, site selection, and protocol design are examined. Pembrolizumab clinical development across many tumor types is reviewed, as are challenges developing a treatment for all genotypes of Hepatitis C.
This document discusses strategies and best practices for adopting medical technology. It emphasizes the importance of health technology assessment (HTA) and knowledge translation (KT) in facilitating evidence-informed decision making. Key challenges include gaps between research evidence and clinical practice. Strategies proposed include creating timely evidence reviews, using frameworks like Know4Go to evaluate technologies based on criteria like effectiveness and costs, and developing institutional capacity for HTA-informed decisions. Local contextualization, collaboration, training, and clinician champions are seen as important for successful technology adoption.
The Business of Genomic Testing by James CrawfordKnome_Inc
This document summarizes the key findings from a survey of 13 early adopter institutions that have implemented next-generation genomic sequencing (NGS) technologies. The survey identified common drivers for adoption including demands from clinical colleagues, anticipated efficiency gains, and acquiring institutional expertise. It also explored barriers such as lack of informatics expertise and high costs. Respondents provided lessons learned such as NGS being more complicated than expected and the importance of multidisciplinary teams. Common measures of successful outcomes included growth in test volumes and expansion of testing menus. The document concludes with recommendations for professional organizations like the College of American Pathologists, including providing educational programs and testing standards.
Sense of urgency, lessons learned, organizational alignment, team approach, training and an increasing engineering and statistical capability at CDER FDA can be expected to facilitate a move by industry towards continues manufacturing, FDA’s current emphasis on ‘statistical confidence’, Process Validation Guidance 2011, is likely to highlight certain issues (e.g., special causes) within current batch processing; these observation will need to be addressed in an appropriate risk-based manner
Ensuring that pragmatic consideration for specifications & control (intended use) is essential and importance of pragmatic decisions should not be forgotten (e.g., as in case of Design Space Vs. SUPAC), Effective regulatory communication (considering the engineering and statistical emphasis) will be crucial for ensuring regulatory uncertainty is managed in a timely manner,
Cancer Cachexia Global Clinical Trials Review, H1, 2013ReportLinker.com
Cancer Cachexia Global Clinical Trials Review, H1, 2013
Summary
GlobalData's clinical trial report, 'Cancer Cachexia Global Clinical Trials Review, H1, 2013" provides data on the Cancer Cachexia clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Cancer Cachexia. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Cancer Cachexia. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
CHIR Best Brains Exchange 22 January 2016Ajaz Hussain
Quality of drugs manufactured in emerging economies: Are cost containment strategies heightening the likelihood of substandard drugs in Canada?
What regulatory, policy, and/ or governance changes are needed to address new and increased risks?
How can Canada prevent and reduce health risks that emerge when the pharmaceutical industry adopts globalized production strategies?
Visioning the Next Decade: NIPTE-FDA CollaborationAjaz Hussain
NIPTE Seminar at US FDA, 16 March 2016.
QBR as an Organizing Principle for the Proposed NIPTE Center of Excellence for Pharmaceutical Formulations (CEPF)
We are defining the problem too narrowly. Our paradigm of pharmaceutical quality sifted long-ago. We have harmonized on a regulatory methodology for QbD (e.g., ICH Q8). However, with the prevailing ontological gaps (for example as illustrated in the continuing challenges posed with the current FDA’s Inactive Ingredient Database) - How good are the scientific explanations in regulatory submissions? Is quality risk-assessment - metaphysical or an epistemological category?
This document discusses current and future innovation in the pharmaceutical industry from the perspective of Merck Research Laboratories. It outlines Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. Statistics are provided on Merck's 2018 clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams. Considerations for clinical trial planning, site selection, and protocol design are examined. Pembrolizumab clinical development across many tumor types is reviewed, as are challenges developing a treatment for all genotypes of Hepatitis C.
Need for an Integrated approach to Formulation Research and Knowledge ManagementAjaz Hussain
1. Confidence in Generics: Need for an Integrated
approach to Formulation Research and Knowledge
Management (Ajaz Hussain)
2. Mechanism for an integrated approach to Formulation
Research, Knowledge Management, & Knowledge
sharing with FDA & Industry (Steve Byrn)
3. Integrated approach for evolving standards for
formulation design - case example NTI's (Ken Morris)
4. Integrated approach for evolving standard for analytical
characterization - case example excipient variability
(Eric Munson)
The investor presentation discusses Cancer Genetics, Inc., a company that provides genomic testing services. It highlights the company's recent growth, including acquisitions, research collaborations, product launches, and patents. The presentation also outlines the company's targeted NGS panel pipeline for diseases like multiple myeloma, CLL, and myeloid cancers. It positions Cancer Genetics as a leader in oncology diagnostics with proprietary tests that can help guide cancer diagnosis, prognosis, and treatment selection.
This document discusses Contract Research Organizations (CROs) and their role in supporting pharmaceutical clinical trials. It provides the following key points:
- CROs are service organizations that conduct clinical trials and other drug development work on behalf of pharmaceutical companies. This outsourcing has grown as drug development has become more complex.
- When deciding whether and how to use a CRO, companies consider tactical, maximal, or strategic outsourcing based on their internal resources. Selecting the right CRO requires evaluating their capabilities, compatibility with the sponsor's needs, and costs.
- Managing the sponsor-CRO relationship is critical to ensure success. This involves clearly defining roles and responsibilities, establishing performance metrics,
This document summarizes a presentation given by Dr. Robert Boorstein on drivers of change in the laboratory market. Five key trends are discussed: laboratory consolidation, growth of central laboratories vs point-of-care testing, new delivery models, new technologies, and increased competition across sectors. Laboratory consolidation is driven by cost reductions and allows for standardization but may shift market power from sellers to buyers. Point-of-care testing is growing rapidly but poses challenges to quality control. New national laboratory companies are emerging focused on unique branded products.
CED Tight Space Innovation Market Entry- final reportBrand Acumen
The document provides a summary of key findings from qualitative research conducted with 26 Key Opinion Leaders (KOLs) regarding convection enhanced delivery (CED) systems. The KOLs discussed the pros and cons of existing CED approaches and alternatives, noting CED's advantages for infusion depth and coverage area but need for improved molecule selection. Real-time monitoring and MRI compatibility were identified as important needs. Challenges included controlling infusion and determining toxicity. Overall CED was viewed as an attractive delivery strategy for drugs and other agents to treat brain tumors and neurodegenerative diseases if these challenges could be addressed.
This document discusses regulatory approval and reimbursement for new medical technologies. It notes challenges with rising costs and uncertainty of drug development. It describes expedited FDA pathways like Fast Track, Priority Review, and Breakthrough Therapy Designation. While approval and coverage don't always align, experiences with parallel FDA/CMS review and conditional approvals in Europe aim to better link evidence standards. Adaptive pathways could approve technologies for narrow uses with commitments for further study. The goal is improving development efficiency and patients' access to promising new options.
The document discusses the EHR4CR project, which aims to develop a trustworthy service platform to access clinical information from electronic health records (EHRs) to improve clinical research. The project has developed a scalable platform used in pilot programs across 11 major hospitals in 5 countries. It is working to expand this platform into a pan-European network to support clinical trial feasibility studies, patient recruitment, and other research activities. Key stakeholders include hospitals, pharmaceutical companies, and the newly formed European Institute for Innovation through Health Data, which will help govern the platform. The goals are to increase clinical trial efficiency, reduce costs, and improve patient care through better use of EHR data for research.
Learn more about the commercial context of clinical trials, and how to leverage international networks to provide input into clinical trial designs that will generate value beyond regulatory approval, and provide supporting data to cause the adoption of medical devices.
Testing times for clinical trials - Perscetives on personalised health careMats Sundgren
Clinical trials face increasing challenges like longer timelines and higher costs due to outdated regulations from the 1970s. Modernizing the clinical trials process could help address these issues through approaches like increased data sharing and reuse of electronic health records. The EHR4CR project aims to develop new business models for pharmaceutical companies to collaborate and reuse hospital patient data from electronic health records to help accelerate patient recruitment and reduce trial timelines. This emphasizes moving towards more personalized, data-driven trials with the right targeted patients through closer collaboration between pharmaceutical companies and healthcare organizations.
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
The Cell Therapy Catapult was established to help grow the UK cell therapy industry by providing facilities, expertise, and funding for collaboration between researchers and industry. It has laboratories and teams working on process development, clinical trials, and business development. In its first year it has over 60 staff and is engaged in both small and large collaborative projects. The goal is to deliver life-changing cell therapies and investible projects that help establish UK leadership in this industry.
NS1450X - Computerized Systems in Clinical ResearchJudson Chase
I am guest lecturer (paid) at the Boston College William F. Connell School of Nursing (more information at http://www.bc.edu/schools/son/aboutus.html).
Three or four times a year I lecture on the application of Computerized Systems in Clinical Research; this is my course deck from 2014.
Health economic modelling in the diagnostics development processcheweb1
This document discusses the use of health economic modelling in the diagnostics development process. It highlights the need for early decision modelling to efficiently design clinical research studies for new diagnostics. Decision modelling can also be used to assess the potential clinical impact and cost-effectiveness of diagnostics across different stages of the validation process. The document describes an example of decision modelling used to help design the OPTIMA trial, which evaluated multiple biomarker tests for stratifying breast cancer treatment. Close collaboration between different stakeholders is important for effective diagnostics evaluation.
CED Tight Space Innovation Market Entry Avastin Glioblastoma ProposalBrand Acumen
This document is a market analysis proposal from Harrison Hayes to Company X for research on establishing a business case for using Company X's Product X Pump for convection enhanced delivery (CED) of drugs locally in organs. The objectives are to help Company X identify advantages of CED over systemic delivery, potential applications and extensions to other diseases, target markets, regulatory requirements, competitors and more. Harrison Hayes would use qualitative research methods including input from key innovation leaders to provide insights into building the case for this local organ delivery approach.
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
Eligibility for national screening programmes can be personalised according to individual risk in order to improve outcomes and reduce costs. Existing methods of economic evaluation can be adapted to identify risk thresholds and help optimise services. We describe the development of a decision model used to evaluate the cost-effectiveness of risk-based screening for diabetic retinopathy.
Author(s) and affiliation(s): Chris Sampson, Office of Health Economics Marilyn James, University of Nottingham David Whynes, University of Nottingham Antonio Eleuteri, University of Liverpool Simon Harding, University of Liverpool.
Conference/meeting: Health Technology Assessment International (HTAi) 2018
Location: Vancouver, Canada
Date: 03/06/2018
This document discusses challenges in assuring pharmaceutical quality and proposes solutions. It begins with two case examples of companies reaching a "tipping point" in moving from reactive to proactive quality approaches. It then outlines how to effectively integrate process analytical technology (PAT) guidance and other quality guidelines to make continual improvement normal, easy and rewarding. Finally, it proposes understanding uncertainty and human factors when assuring quality, and providing a framework to classify gaps to address challenges. The overall message is that recognizing legacy issues and integrating quality approaches can help advance from problem-solving to error prevention.
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
This webinar presentation discusses operationalizing advanced therapy clinical trials using lessons learned from past experiences. The webinar covers regulatory considerations, operational challenges, and case studies. Regulatory agencies require strategic engagement, assessment of regulatory readiness, and oversight of country requirements. Investigative sites face additional committee reviews and license applications. Manufacturing complex cell and gene therapies poses challenges around process transfer, scaling, and product availability. Aligning supply chain readiness, site capabilities, and an investigational product tracking process is key to avoiding delays. Developing a global strategy requires addressing requirements for manufacturing, stability data, labeling, and supply logistics early.
Patient engagement in clinical trials Martin Kelly
The document discusses improving patient engagement in clinical trials through digital methods. Only 2-5% of cancer patients currently participate in clinical trials. The top 3 solutions identified to engage patients were: 1) a clinical trial finder for patients to inform them of available trials, 2) virtual clinical trials conducted entirely online, and 3) tools to personalize clinical trials to individual patient needs/preferences. The document reviews several companies providing these types of solutions and proposes an experiment partnering with a CRO to test if a digital intervention increases patient enrollment and retention in a clinical trial compared to a control group without a digital intervention.
This document discusses the need for patient-centered clinical trials due to rising complexity, costs and failure rates of traditional trials. It notes delays in enrollment are a major issue, inflating costs and timelines. Protocols have become more complex and burdensome, reducing adherence and retention. The future requires improving recruitment methods, incorporating patient needs, and placing data generation in patients' hands through technologies like social media and ePRO tools. Patient-centered approaches may help address these challenges and better support drug development.
Need for an Integrated approach to Formulation Research and Knowledge ManagementAjaz Hussain
1. Confidence in Generics: Need for an Integrated
approach to Formulation Research and Knowledge
Management (Ajaz Hussain)
2. Mechanism for an integrated approach to Formulation
Research, Knowledge Management, & Knowledge
sharing with FDA & Industry (Steve Byrn)
3. Integrated approach for evolving standards for
formulation design - case example NTI's (Ken Morris)
4. Integrated approach for evolving standard for analytical
characterization - case example excipient variability
(Eric Munson)
The investor presentation discusses Cancer Genetics, Inc., a company that provides genomic testing services. It highlights the company's recent growth, including acquisitions, research collaborations, product launches, and patents. The presentation also outlines the company's targeted NGS panel pipeline for diseases like multiple myeloma, CLL, and myeloid cancers. It positions Cancer Genetics as a leader in oncology diagnostics with proprietary tests that can help guide cancer diagnosis, prognosis, and treatment selection.
This document discusses Contract Research Organizations (CROs) and their role in supporting pharmaceutical clinical trials. It provides the following key points:
- CROs are service organizations that conduct clinical trials and other drug development work on behalf of pharmaceutical companies. This outsourcing has grown as drug development has become more complex.
- When deciding whether and how to use a CRO, companies consider tactical, maximal, or strategic outsourcing based on their internal resources. Selecting the right CRO requires evaluating their capabilities, compatibility with the sponsor's needs, and costs.
- Managing the sponsor-CRO relationship is critical to ensure success. This involves clearly defining roles and responsibilities, establishing performance metrics,
This document summarizes a presentation given by Dr. Robert Boorstein on drivers of change in the laboratory market. Five key trends are discussed: laboratory consolidation, growth of central laboratories vs point-of-care testing, new delivery models, new technologies, and increased competition across sectors. Laboratory consolidation is driven by cost reductions and allows for standardization but may shift market power from sellers to buyers. Point-of-care testing is growing rapidly but poses challenges to quality control. New national laboratory companies are emerging focused on unique branded products.
CED Tight Space Innovation Market Entry- final reportBrand Acumen
The document provides a summary of key findings from qualitative research conducted with 26 Key Opinion Leaders (KOLs) regarding convection enhanced delivery (CED) systems. The KOLs discussed the pros and cons of existing CED approaches and alternatives, noting CED's advantages for infusion depth and coverage area but need for improved molecule selection. Real-time monitoring and MRI compatibility were identified as important needs. Challenges included controlling infusion and determining toxicity. Overall CED was viewed as an attractive delivery strategy for drugs and other agents to treat brain tumors and neurodegenerative diseases if these challenges could be addressed.
This document discusses regulatory approval and reimbursement for new medical technologies. It notes challenges with rising costs and uncertainty of drug development. It describes expedited FDA pathways like Fast Track, Priority Review, and Breakthrough Therapy Designation. While approval and coverage don't always align, experiences with parallel FDA/CMS review and conditional approvals in Europe aim to better link evidence standards. Adaptive pathways could approve technologies for narrow uses with commitments for further study. The goal is improving development efficiency and patients' access to promising new options.
The document discusses the EHR4CR project, which aims to develop a trustworthy service platform to access clinical information from electronic health records (EHRs) to improve clinical research. The project has developed a scalable platform used in pilot programs across 11 major hospitals in 5 countries. It is working to expand this platform into a pan-European network to support clinical trial feasibility studies, patient recruitment, and other research activities. Key stakeholders include hospitals, pharmaceutical companies, and the newly formed European Institute for Innovation through Health Data, which will help govern the platform. The goals are to increase clinical trial efficiency, reduce costs, and improve patient care through better use of EHR data for research.
Learn more about the commercial context of clinical trials, and how to leverage international networks to provide input into clinical trial designs that will generate value beyond regulatory approval, and provide supporting data to cause the adoption of medical devices.
Testing times for clinical trials - Perscetives on personalised health careMats Sundgren
Clinical trials face increasing challenges like longer timelines and higher costs due to outdated regulations from the 1970s. Modernizing the clinical trials process could help address these issues through approaches like increased data sharing and reuse of electronic health records. The EHR4CR project aims to develop new business models for pharmaceutical companies to collaborate and reuse hospital patient data from electronic health records to help accelerate patient recruitment and reduce trial timelines. This emphasizes moving towards more personalized, data-driven trials with the right targeted patients through closer collaboration between pharmaceutical companies and healthcare organizations.
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
The Cell Therapy Catapult was established to help grow the UK cell therapy industry by providing facilities, expertise, and funding for collaboration between researchers and industry. It has laboratories and teams working on process development, clinical trials, and business development. In its first year it has over 60 staff and is engaged in both small and large collaborative projects. The goal is to deliver life-changing cell therapies and investible projects that help establish UK leadership in this industry.
NS1450X - Computerized Systems in Clinical ResearchJudson Chase
I am guest lecturer (paid) at the Boston College William F. Connell School of Nursing (more information at http://www.bc.edu/schools/son/aboutus.html).
Three or four times a year I lecture on the application of Computerized Systems in Clinical Research; this is my course deck from 2014.
Health economic modelling in the diagnostics development processcheweb1
This document discusses the use of health economic modelling in the diagnostics development process. It highlights the need for early decision modelling to efficiently design clinical research studies for new diagnostics. Decision modelling can also be used to assess the potential clinical impact and cost-effectiveness of diagnostics across different stages of the validation process. The document describes an example of decision modelling used to help design the OPTIMA trial, which evaluated multiple biomarker tests for stratifying breast cancer treatment. Close collaboration between different stakeholders is important for effective diagnostics evaluation.
CED Tight Space Innovation Market Entry Avastin Glioblastoma ProposalBrand Acumen
This document is a market analysis proposal from Harrison Hayes to Company X for research on establishing a business case for using Company X's Product X Pump for convection enhanced delivery (CED) of drugs locally in organs. The objectives are to help Company X identify advantages of CED over systemic delivery, potential applications and extensions to other diseases, target markets, regulatory requirements, competitors and more. Harrison Hayes would use qualitative research methods including input from key innovation leaders to provide insights into building the case for this local organ delivery approach.
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
Eligibility for national screening programmes can be personalised according to individual risk in order to improve outcomes and reduce costs. Existing methods of economic evaluation can be adapted to identify risk thresholds and help optimise services. We describe the development of a decision model used to evaluate the cost-effectiveness of risk-based screening for diabetic retinopathy.
Author(s) and affiliation(s): Chris Sampson, Office of Health Economics Marilyn James, University of Nottingham David Whynes, University of Nottingham Antonio Eleuteri, University of Liverpool Simon Harding, University of Liverpool.
Conference/meeting: Health Technology Assessment International (HTAi) 2018
Location: Vancouver, Canada
Date: 03/06/2018
This document discusses challenges in assuring pharmaceutical quality and proposes solutions. It begins with two case examples of companies reaching a "tipping point" in moving from reactive to proactive quality approaches. It then outlines how to effectively integrate process analytical technology (PAT) guidance and other quality guidelines to make continual improvement normal, easy and rewarding. Finally, it proposes understanding uncertainty and human factors when assuring quality, and providing a framework to classify gaps to address challenges. The overall message is that recognizing legacy issues and integrating quality approaches can help advance from problem-solving to error prevention.
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
This webinar presentation discusses operationalizing advanced therapy clinical trials using lessons learned from past experiences. The webinar covers regulatory considerations, operational challenges, and case studies. Regulatory agencies require strategic engagement, assessment of regulatory readiness, and oversight of country requirements. Investigative sites face additional committee reviews and license applications. Manufacturing complex cell and gene therapies poses challenges around process transfer, scaling, and product availability. Aligning supply chain readiness, site capabilities, and an investigational product tracking process is key to avoiding delays. Developing a global strategy requires addressing requirements for manufacturing, stability data, labeling, and supply logistics early.
Patient engagement in clinical trials Martin Kelly
The document discusses improving patient engagement in clinical trials through digital methods. Only 2-5% of cancer patients currently participate in clinical trials. The top 3 solutions identified to engage patients were: 1) a clinical trial finder for patients to inform them of available trials, 2) virtual clinical trials conducted entirely online, and 3) tools to personalize clinical trials to individual patient needs/preferences. The document reviews several companies providing these types of solutions and proposes an experiment partnering with a CRO to test if a digital intervention increases patient enrollment and retention in a clinical trial compared to a control group without a digital intervention.
This document discusses the need for patient-centered clinical trials due to rising complexity, costs and failure rates of traditional trials. It notes delays in enrollment are a major issue, inflating costs and timelines. Protocols have become more complex and burdensome, reducing adherence and retention. The future requires improving recruitment methods, incorporating patient needs, and placing data generation in patients' hands through technologies like social media and ePRO tools. Patient-centered approaches may help address these challenges and better support drug development.
This white paper discusses four ways that pharmaceutical and biotechnology companies can accelerate their clinical portfolio strategy using advanced analytics and clinical trial data and technology. It provides examples of how visualizing clinical trial data over time, benchmarking trial durations, mapping competitive drug pipelines, and comparing safety profiles across trials can provide insights to help with strategic decision making regarding clinical development.
Customized Oncology Development Solutions: Clinical Trials Designed Around You®Covance
Covance provides customized clinical trial solutions and services for oncology drug development. Their services include utilizing patient lab data to assess trial feasibility and identify eligible patients, scientific consultation in precision medicine areas, and selecting investigator sites with the right patients and experience. Covance aims to help clients accelerate development timelines, improve the probability of success, and deliver trials on budget.
The Avoca Quality Consortium Summit 2014 Executive SummaryThe Avoca Group
This document provides an executive summary of the 2014 Avoca Quality Consortium Summit. The summit brought together quality, outsourcing, and operational professionals from pharmaceutical, biotech, clinical service providers, and contract research organizations to accelerate the development of best practices for quality management and CRO oversight. The two-day event featured sessions on collaborating with patients, quality by design, insights on quality and effectiveness, and reinventing decision making. It also recognized sponsors Eli Lilly and Company and Pfizer as well as inVentiv Health Clinical for their support. The Avoca Quality Consortium aims to serve as a catalyst for optimizing approaches to proactive quality management and risk mitigation through industry collaboration.
NASSCOM CoE IoT spearheaded a high-level industry roundtable to discuss firsthand the challenges & opportunities in India’s clinical trial industry and how technology can accelerate development
Clinical trial transparency requirements are becoming more complex, with evolving regulations and demands for greater disclosure. This creates compliance risks for sponsors. A technology solution is needed to manage clinical trial content, automate disclosure processes, and ensure accuracy and timeliness across global registries. An effective solution incorporates a platform approach, risk-based validation, SaaS deployment model, and content management foundation to address this challenge. Technology can help sponsors improve efficiency, mitigate risks, and respond to demands for increased transparency.
Using real-time-data-to-drive-better-decisions-fasterPrateek Rathi
This document discusses the opportunities and risks associated with using real-time data access during clinical trials. It examines how real-time data can enhance patient safety, strengthen quality, and accelerate timelines by allowing drug developers to review data shortly after collection and make faster decisions. However, it also notes risks like unintentionally unblinding trials or introducing bias if not properly controlled. The document provides guidelines for granting access based on roles and recommends only giving access to pre-treatment data rather than on-treatment data to most roles. It emphasizes the need for protocols outlining how real-time data will be used and establishing firewalls to mitigate risks while enabling the benefits of real-time data reviews.
Big data, RWE and AI in Clinical Trials made simpleHadas Jacoby
Technology is slowly but surely penetrating the healthcare industry in general and the clinical trials sector in particular. New and advanced solutions offer a variety of possibilities aimed to both improving existing processes and creating new and more efficient ones. And on top of all stands the desire to make clinical trials more patient centric.
In all of this, even though some of the technologies have yet to mature enough to meet the high quality standards necessary, it is important to know them and begin imagining the promise they hold for clinical trials.
Solving the operational challenges of oncology clinical trialsRoberto Lara
This executive briefing explores new strategies for solving your oncology clinical operations challenges. It also features valuable insights into how you can enrich your site selection, speed up your start-up times and maximize patient recruitment opportunities here in North America.
Clinical Trials Are Medically Based ExperimentsRachel Phillips
Clinical trials are medically based experiments undertaken on human subjects to systematically determine the effectiveness and/or safety of therapeutic interventions. They are created to measure things like determining if a treatment is more effective than a placebo or if one treatment is more effective than another. Clinical trials must comply with various guidelines and regulations to protect human subjects, ensure safety, and create an environment favorable for conducting research with the highest standards of patient safety.
The Science of Launching and Achieving Growth in Oncologyaccenture
We have conducted research to understand how oncology companies are responding to New science, more treatment choices and changing economics. Visit https://accntu.re/2Jn72wq to learn our key takeaways for launching and achieving growth in oncology.
The document discusses the process and costs associated with drug development. It notes that the average cost to develop a new drug is $350 million to $5.5 billion and the process takes 6.5-7 years from discovery to approval. Key barriers to drug development include high financial costs, lengthy timelines for clinical trials, and regulatory hurdles. Approaches to reduce costs and timelines include greater use of electronic health records, simplifying clinical trial protocols, and utilizing decentralized clinical trial models.
Nommas Life Sciences is developing diagnostic tests using proprietary lambody technology to detect various cancers. Their first product, NCDK, will be a point-of-care ELISA-like kit that can detect multiple cancers from a single patient sample. Nommas aims to raise $750,000 over 2 years to further develop their platform and commercialize NCDK. If successful, NCDK will fulfill an unmet need in cancer diagnostics and help Nommas become a leader in the field of precision oncology diagnostics. However, Nommas faces competition from large companies and must overcome regulatory hurdles to achieve commercial success.
The document discusses Strand Genomics Inc., which offers genomic analysis and clinical interpretation software and services. It focuses on personalized medicine by using its StrandOmics platform to analyze genomic data and determine disease risks for individuals. StrandOmics aims to make genomic testing routine in medical care to help clinicians make more informed decisions. Strand has grown to over 200 scientists and serves over 2,000 labs and 100,000 patients. Its partnership with Health Care Global Enterprises successfully piloted cancer risk assessment and molecular diagnosis for over 50 patients in India.
1) The EHR4CR project developed a platform to facilitate clinical research by enabling access to de-identified patient health records across countries, systems, and sites.
2) The platform supports protocol feasibility testing, patient recruitment, and data capture/exchange through a network of hospitals in multiple European countries.
3) Going forward, the EHR4CR Champion Program aims to further validate and scale up the platform through partnerships with additional hospitals and research organizations, overseen by the newly formed European Institute for Innovation through Health Data.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
RFID technology has the potential to significantly improve clinical trials by automating documentation processes and reducing errors. Currently, critical information such as drug inventory, dispensing records, and environmental storage conditions are documented through manual and paper-based methods, which are prone to inaccuracies and incomplete records. RFID could provide real-time monitoring and automated documentation of this information, improving accountability, compliance, and efficiency. This would help speed drug development and reduce costs for pharmaceutical companies conducting large, long-term clinical trials that currently rely on labor-intensive manual documentation processes.
Clinical trials are used to test whether new medical treatments work effectively and actually treat a disease. Conducting and designing clinical trials today can take years and cost millions of dollars. A workshop was held with clinical trial experts to discuss challenges in conducting clinical trials and ways to improve efficiency while maintaining high standards. The workshop focused on cardiovascular disease, depression, cancer, and diabetes and gained insights into differences in clinical trials by disease that could help overall improvement. Future work will further analyze regulatory, administrative, and financial barriers to effective clinical trials and develop a vision for a sustainable clinical research infrastructure in the United States.
Optimizing the Output of Your Molecular Pathology LaboratoryJosh Forsythe
If you are a clinical lab looking to build or accelerate your NGS testing capability where do you start? The components of success can be overwhelming - planning, assay design, validation, clinical lab workflow, informatics, and interpretation.
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2. PAGE 2
EXECUTIVE SUMMARY
Every year, members of the Association of Clinical Research Organizations (ACRO), and the 100,000 research
professionals they employ, conduct more than 9,000 clinical trials in 142 countries around the world.
The purpose is simple: bring life-changing medicines to market as efficiently and safely as possible, so patients
can get the treatments they need.
Clinical research organizations (CROs) pursue innovation in clinical trials because a competitive industry demands
it, and because it’s what patients awaiting new medicines deserve. Research sponsors choose to work with clinical
research organizations because they have confidence CROs will work tirelessly to conduct safe, thorough trials on
schedule and within budget.
Clinical trials today are more responsive, individualized, and effective because it’s written into the DNA of CROs to
challenge the status quo. CROs are harnessing real-time data analytics and visual reporting software tools; they’re
building innovative strategic partnerships, and breaking down communication barriers between trial sponsors,
trial sites, patients, and even regulators.
These process innovations help patients get access to life-saving treatments faster and encourage continued
investment in the development of medicines and rare-disease treatments around the world.
Truly optimizing the process and potential of clinical trials, however, requires more than just the commitment
of CROs. Legislative and regulatory policies must be made to align with industry efforts and similarly foster
innovation. Recommendations for policy improvements in the United States and European Union are included at
the conclusion of this document.
9,000 CLINICAL TRIALS
142 COUNTRIES
1.4 MILLION PATIENTS
The top US states for CRO employment are North Carolina, Pennsylvania,
Massachusetts, New Jersey, Texas, and California; the top European locations for
CRO employment are the United Kingdom, Germany, France, and Spain
3. PAGE 3
TABLE OF CONTENTS
The Necessity of Clinical Trials.................................................................................... 4
Clinical Trials: A Legacy of Innovation........................................................................... 4
Clinical Trials Today.................................................................................................... 5
The Future of Clinical Trials......................................................................................... 7
Policy Recommendations to Complement Clinical Research Innovations......................... 8
United States..............................................................................................................................8
European Union (EU)..................................................................................................................9
Conclusion................................................................................................................10
Case Studies: Clinical Research Organizations: Improving Trials at Every Phase .............11
Case 1 – Progress Requires Partnerships: Collaborative Innovation Helps
Fast Track Rare Condition Study .............................................................................................11
Case 2 - Innovation in Trial Recruitment Speeds the Clinical Trial Process ..........................11
Case 3 - Clinical Trial Costs Reduced Through Innovative Partnerships
and a Revised Trial Design.......................................................................................................12
Case 4 - Innovative Partnerships Put Cardiovascular Treatment Trial One Year
Ahead of Schedule....................................................................................................................12
Case 5 - CRO-Championed Innovation Leads to Early Completion for
Global Study of Rare Pediatric Condition ...............................................................................13
Case 6 - Adaptive Trial Design Cuts Costs for Cancer Study by More Than $1 Million ..........14
Case 8 - Innovations in Data Management and Strategic Partnerships
Achieve Cost-Savings for Biopharmaceutical Trial Sponsor ................................................15
Case 9 - Clinical Trial Innovations Expedite Recruitment, Prioritize Communication,
and Streamline Logistics for a Global COPD Trial .................................................................16
Case 10 – Bringing Treatments to Market Through CRO-Supported
Commercial Infrastructure.......................................................................................................17
Case 11 - Making the Most of Data: Adopting eClinical Systems Allows CROs
to Visually Track Safety Data in Real-Time..............................................................................17
Case 12 - Adaptive Trial Designs Maximize Trial Efficiency....................................................18
About ACRO...............................................................................................................19
4. PAGE 4
THE NECESSITY OF CLINICAL TRIALS
It takes successful clinical trials for patients around the world to get access
to the life-saving medicines they need.
Pharmaceutical, biotech, and medical device companies invest billions
of dollars to develop treatments and medicines, but before these reach
patients, rigorous testing must take place to ensure safety and gauge how
treatments perform over time. Clinical research organizations design and
implement those tests.
Clinical trials are essential to the drug development process, which in
and of itself is a lengthy, expensive, and complex undertaking. On average,
bringing a new drug to market can take 15 years and cost as much as
$1.2 billion.
The drug development process—involving discovery, pre-clinical research,
clinical trials, and regulatory approval—requires collaboration among trial
sponsor staff, regulators, physicians, academic researchers, and patients.
ACRO member companies contribute to all aspects of drug development
with an emphasis on Phase I – IV clinical trials and related laboratory
services.
CLINICAL TRIALS: A LEGACY OF INNOVATION
Clinical research organizations have always sought to bring greater
efficiency to the clinical trial process. ACRO members have been leaders
in promoting common data standards throughout the clinical research
industry, a collaborative practice that ensures data from various clinical
trials is standardized to ease regulatory review and promote sharing
among researchers for greater efficiency. Additionally, ACRO members have
led in the implementation of Good Clinical Practices to prioritize patient
safety and maintain trial quality throughout the clinical research process.
ACRO members have also been early adopters of new technologies and
big ideas in clinical trials that have driven innovation throughout the drug
development process. CROs have been quick to embrace and capitalize
on the efficiencies of electronic data capture and have helped drive the
globalization of clinical trials, bringing research opportunities to more
patients than ever before and driving efficiency and expediency in the
development of new, life-changing medicines and treatments.
Clinical trials conducted by CROs are completed on average 30 percent
more quickly than those conducted by sponsoring companies or
academic research organizations (AROs) in-house. This results in average
time savings of somewhere between four and five months, which is an
invaluable period of time for patients in need of treatments. Additionally, the ability of CROs to complete clinical
trials more expeditiously translates to $120 million to $150 million in development cost savings.
LABORATORY STUDIES
3–6 years
FDA APPROVAL
6 months–2 years
CLINICAL TRIALS
3–6 years
PHASE 1
First in Human
PHASE 2
Efficacy
PHASE 3
Product Registration
180%
GROWTH
$14.2 BILLION
IN REVENUES
Over the past 10 years,
CRO business has grown 180%,
with ACRO member revenues
reaching an estimated $14.2
billion—representing roughly
two-thirds of all worldwide
investment in contract
biopharmaceutical
development.
5. PAGE 5
Saving time and money in the clinical research process is absolutely essential both for biopharmaceutical
developers and patients around the world. Among the biggest challenges confronted in clinical research are the
stunningly high costs of drug discovery, tight time constraints to prepare for trials and complete trial benchmarks
within budget, myriad regulatory hurdles in the U.S. and abroad, and the critical task of finding the right patients
to become trial participants.
According to Tufts University, 48 percent of sites in a given trial under-enroll or fail to enroll a single patient. Delays
caused by a failure in patient enrollment are costly. A study on clinical trial performance by respected industry
analyst firm Gartner estimated that one day of drug development costs a sponsor $37,000 in operational costs,
with opportunity costs for delayed drugs ranging from $600,000 to $8 million per day.
CLINICAL TRIALS TODAY
ACRO members are doing their part to overcome
challenges and bring about more efficient, patient-
centered trials. Partnering with biopharmaceutical
companies and thought leaders in the research space,
CROs are finding and implementing innovative solutions
to make trials more affordable and increase efficiency
throughout, all to bring life-saving drugs, treatments,
therapies, and medical devices to market as quickly and
safely as possible. Fittingly, demand for CRO services is
growing among pharmaceutical, biotech, and medical
device companies.
Optimized clinical research requires collaboration. On a global scale, ACRO members are engaging regulators like
the FDA and EMA and forming innovative partnerships with academic researchers, trial sponsors, patient groups,
and trial sites to streamline patient recruitment, accommodate adaptive trial designs, and break down barriers to
communication.
Given the scope of the patient recruitment challenge in clinical trials,
ACRO members are rethinking trial recruitment and enrollment
processes. In some instances where the pool of eligible global
participants is particularly small and the distance between patients and
clinical sites could pose a barrier to entry, ACRO members are thinking
outside the box.
• ACRO member INC Research went so far as to incorporate expertise
from a travel agency to arrange accommodations for prospective
patients in a global study of a rare pediatric neurological disorder.
• PAREXEL, another ACRO member, launched an aggressive ad and
text message outreach campaign to successfully recruit participants
in a 13-day time period.
• ACRO member inVentiv Health Clinical chartered a Clinical
Trial Educators Program designed to leverage the expertise of
experienced professionals to coach and assist sponsors and trial
sites through successful recruitment and trial administration.
“It’s a very humbling
business to be in. When you
experience how actual
patients are benefitting
from clinical trials that
change their lives, it’s a
wonderful thing.”
Jay Dixon, PPD
6. PAGE 6
Clinical trials produce an overwhelming volume of data, with CROs delivering more than 100 million central
laboratory test results and managing more than 1 million square feet of lab space around the world. Mastering
data tracking and analysis at each and every clinical site, of which there are approximately 27,000, is one of the
keys to reducing the overall time and cost of trials. ACRO members are on the front lines of data innovation and
integration, developing solutions to make the most of the information collected over the course of a trial.
Recognizing that real-time data tracking enables risk-based monitoring
and adaptive trial design, ACRO member PPD created a “protocol
optimization” process to leverage trial data toward more cost-efficient
and time-efficient trials. In one oncology study, the use of protocol
optimization led to a savings of $1.2 million and an accelerated
trial timeline. Both PPD and ACRO member ICON have also developed
dynamic software solutions to track and respond to trial data in real time,
allowing clinical research associates (CRAs) to monitor and optimize
clinical trials as they are being conducted.
ACRO members see data integration as a gateway to personalized
medicine. Dr. Nicholas Alp from ICON remarked recently that successful
data integration “means helping primary data sources – from patients,
from clinical operations, and from many other sources – to speak
together, integrate, and aggregate.” He went on to say that integrating
enormous amounts of living data from trials will enable clinical research
organizations to individualize appropriate treatments for patients, given their particular health and disease state.
That, he said, “will have an enormous impact on how we plan and conduct clinical trials in the future.”
With all the exciting developments in clinical trials today, there
is a notable shift taking place toward personalized medicine and
customization for rare diseases. PPD’s Senior Vice President of Global
Quality and Compliance, Jay Dixon, says, “The changing development
paradigm is making the classical clinical trial a thing of the past.”
More information on clinical trial innovations championed by ACRO
members is included in the Case Studies section of this document.
“The changing development
paradigm is making the
classical clinical trial a thing
of the past.”
Jay Dixon, PPD
• ACRO members contributed to the
development of 85 of the 88 new drugs
approved by the FDA and EMA last year
and to all of the top 20 selling drugs.
• ACRO members contributed to the
development of 19 of the 20 biosimilars
that have been approved globally.
• Breast cancer, Alzheimer’s disease,
hepatitis, diabetes, asthma,
hypertension, and vaccines are among
the most researched indications
by CROs.
• On average, each ACRO member works
with more than 500 research sponsors
and approximately 27,000 research sites
every year.
“Patients are becoming
much more informed…
and they’re aggressively
going to sites and looking
for trials to be involved in.”
Alistair Macdonald, INC Research
7. PAGE 7
THE FUTURE OF CLINICAL TRIALS
Because of innovations and partnerships that have increased the
value and power of data in trials today, clinical trials in the future
are likely to be smaller, faster, and involve fewer participants.
All the while, patient involvement in the clinical trial process is
likely to increase as INC Research Chief Operating Officer Alistair
Macdonald notes.
“Patients,” he says, “are becoming much more informed…and
they’re aggressively going to sites and looking for trials to be
involved in.”
The push to amplify the voices of clinical trial patients throughout the industry has already begun, says Jay Dixon.
“I think an area that we really need to bring in is the patient advocacy, really understanding at the end of the day,
when we help a client commercialize a product, the end product is there for a patient.” Dixon and others advocate
incorporating patients and patient advocacy groups into the design of clinical trials.
With more patient involvement and continued progress in the areas of data management, recruitment innovation,
and strategic partnerships within the CRO industry, we expect to see the following from clinical trials in the future:
• Individualized medicine—trials will pair the right medicine with the right patients at the right time
As data enables researchers to learn more about patients and drugs at the same time, future clinical trials
will be focused on developing therapies that are more individualized, personalized, and targeted to the right
patients, based upon their genetic makeup and other factors. Diagnostic tests developed in conjunction
with drugs will help identify the individuals who are right for a specific study, and which specific treatment
individual patients should receive for their common condition.
• Patient-centric protocols
The process of increasing patient involvement in clinical trials is going on now and will continue into the
future where patients will be involved earlier and earlier in the clinical research process. Trials will be
designed to take into consideration what patients identify as being important to them and the various risk
levels patients are willing to assume in the course of a trial.
• Direct patient engagement
The days of physician referrals being the only point of entry for
clinical trials are gone. Social media and innovative recruitment
techniques will continue to empower patients to find, choose, and
enroll themselves in clinical trials.
• More standardized, turnkey investigator networks
Because of longstanding relationships with investigative sites, CROs
already possess a detailed understanding of which sites are best
qualified in various therapeutic areas, which are most effective
at patient recruitment, and which can be relied upon to produce
the highest quality data. In years to come, we expect to see this
knowledge spread throughout the clinical trial space as it is critical
to ensuring that studies start and finish on time, that patients
receive proper care, and that trial results are most reliable.
“Through integrating this
enormous amount of living
data, we can start to do
things that we can only
dream of right now…”
Dr. Nicholas Alp, ICON plc
8. PAGE 8
• Accessibility for patients around the world
Trials are becoming more and more globalized and the means for patients to learn about trials is no longer
confined to the walls of their physician’s office. Recruitment efforts will continue reaching out to patients
directly and information about clinical trials and trial eligibility will hopefully be centralized and more robust
in the future.
• Responsive, flexible trial designs
Closer collaboration between regulators, sponsors, and CROs will make it possible for more trials to make
adjustments to protocols in response to trial data and refine and improve outcomes in the midst of a trial.
Reaching this optimized state and realizing all of the potential for future clinical trials requires more than just
innovation within the CRO space. CROs are refining trial processes, developing data management tools to simplify
and streamline trials, and building relationships with the regulators, physicians, and trial sponsors to meet an
industry need to make trials as time efficient and cost efficient as possible. That industry-led innovation will
continue because that’s what trial sponsors demand and that’s what’s needed to get life-saving treatments to
patients.
Industry innovation, however, can only accomplish so much. There are policies and matters under government’s
purview that must be improved as well.
POLICY RECOMMENDATIONS TO COMPLEMENT CLINICAL
RESEARCH INNOVATIONS
In order to ensure that there remains an atmosphere conducive to innovation and medical research and
development, and for more trials to be successful and for investments in trials to pay off, regulations for
clinical trials must be clear and predictable. There also must be even more cooperation, collaboration, and
communication among regulatory bodies, research sponsors, and CROs.
United States
About half of clinical trials take place in the United States—more than any other nation in the world. ACRO’s
legislative agenda in the U.S. is focused on promoting policies that foster innovation in the medication
development process and ensure that the U.S. remains a competitive venue for clinical trials.
To improve and optimize the work of clinical research organizations in the United States, we recommend:
• Supporting the passage of S. 2715, the Compete Act
Permanently extending the R&D tax credit and other competitive tax policies which recognize the critical role
CROs play in medical product development will foster innovation in the United States clinical trial space.
• Advocating for the integration of electronic health records (EHRs) with the federal database of
clinical trials
Allowing the integration of EHRs with clinicaltrials.gov, the federal government’s comprehensive database
of clinical trials, will facilitate awareness of clinical trials among doctors and patients and help in the
determination of which trials may be most appropriate and convenient for individual patients.
• Updating and expanding www.ClinicalTrials.gov
ClinicalTrials.gov is not as helpful as it could be for patients or researchers. In fact, it’s often seen as
intimidating and unclear. The site’s database of clinical trials, however, is the most robust available.
9. PAGE 9
Improving the user experience at ClinicalTrials.gov, expanding the information that is included, and also
allowing for EHR integration with the database will facilitate better research and empower patients with
information about clinical trials for which they may be eligible.
• Fostering better collaboration with the FDA
Making it explicitly clear within the development process that regulators, trial sponsors, and CROs may
communicate before and during trials will improve trial outcomes, advance the adoption of adaptive trial
designs, and promote a culture of innovation within the FDA itself.
• Updating HIPAA to accommodate the realities of 21st century data exchange and usage for
research purposes
“Big Data” has the potential to be a game-changer in medical research, transforming everything from clinical
trial recruitment to the ways health outcomes are studied. For this potential to be fully realized, however,
HIPAA must be modernized to allow and encourage the free exchange of electronic health data while
safeguarding patient privacy.
• Supporting the 21st Century Cures initiative launched by the House Energy & Commerce Committee
Federal laws and regulations must keep pace with the innovation and improvements taking place in
the clinical trial space. Policy reform can advance improvements in discovery, solutions in treatment
development, and more timely delivery of innovative treatments so patients can benefit.
European Union (EU)
With nearly 30 percent of all clinical trials taking place in the EU, it is critical to ensure regulatory structures and
research quality standards are in place to support the advancement of clinical research and protect patients
across Europe.
To improve and optimize the research environment in Europe, we recommend:
• Fully implementing the Clinical Trials Regulation
Full implementation of the Clinical Trials Regulation throughout Europe will bring clarity and efficiency to the
regulations governing contract research. It will also ensure a competitive and robust research ecosystem for
medicinal discovery.
• Adopting suitable data protection and privacy standards
Robust standards will respect patients’ privacy rights while also enabling the responsible exchange and use
of health information for specific research purposes.
• Approving policies that encourage clinical research and innovation
Competitive regulatory, tax, and business policies will encourage responsible experimentation and
innovation in Europe’s clinical trials.
• Clarifying regulations to identify which party or parties in the research process bear responsibility
for compliance
Some current regulations are unclear about which party is responsible for ensuring compliance with
regulatory obligations in clinical trials.
10. PAGE 10
CONCLUSION
Every day, clinical research professionals are thinking of new ways to improve
the clinical trial process. By advocating for patient-centered, responsive
medical research on a global scale, ACRO members are helping advance policies
that encourage innovation in pharmaceutical, biologic, and medical device
development.
Technology today is driving innovation in how CROs collect, aggregate, and
analyze data. In fact, data is empowering the drive toward truly individualized
medicine. It enables CROs to track and respond to risks and other issues in real
time, making the trial process more nimble and responsive. And it facilitates
adaptive trial designs, which make it possible for trials to arrive at the heart
of the matter faster—whether a medicine or treatment will actually work for
patients.
ACRO and its member companies will continue to disrupt the status quo and
strengthen relationships with policy makers, regulatory bodies, and government officials worldwide to ensure the
advancement of safe, high-quality clinical trials. ACRO will also work to promote tax, trade, and business policies that
prioritize innovation—because that is part of the CRO identity. Innovation is in its very fabric.
11. PAGE 11
CASE STUDIES: CLINICAL RESEARCH ORGANIZATIONS:
IMPROVING TRIALS AT EVERY PHASE
Case 1 – Progress Requires Partnerships: Collaborative Innovation Helps Fast Track Rare
Condition Study
Location of Case: USA
Company Featured: Covance
Innovation Example: Collaborative Innovation
A pharmaceutical company in the Midwest needed help developing two monoclonal antibody therapies for
occlusive crisis rare hematological disorder, a condition which impacts more than 100,000 Americans.
The company turned to ACRO member Covance to develop and conduct its IND-enabling program, which included
a range of nonclinical safety assessment studies—such as four-week toxicology studies, tissue cross reactivity
studies, and the associated analytical chemistry necessary to prove the drug’s safety and green-light it for
administration to trial patients.
Program Management and Phase I trial experts were brought in at the ground floor by Covance to collaborate,
discuss regulatory strategy, and set the terms for the pharmaceutical company’s trial. Covance’s bold step of
involving its clinical team during preclinical data review led to a seamless transition into trial Phase I, where
preclinical molecule learnings were incorporated thoroughly into the trial’s clinical and post-IND
development strategies.
Such end-to-end collaborative innovation enabled Covance’s pharmaceutical client to reach its first critical
milestone between three and six months earlier than expected, saving them money and nearly halving the
typical development time of 12 months.
The occlusive crisis rare hematological disorder treatment compound, now in Phase II clinical trials, was recently
licensed by a large pharmaceutical development partner for commercialization. Because of the efficiency and
speed accomplished through the collaborative development process, these life-changing therapies are on a much
faster track to reach patients.
Case 2 - Innovation in Trial Recruitment Speeds the Clinical Trial Process
Location of Case: EU
Company Featured: PAREXEL
Innovation Example: Innovation in Trial Recruitment
A client new to early phase research, on a tight budget, and operating within strict time constraints, turned to
ACRO member PAREXEL and its Berlin-based Early Phase Clinical Unit for guidance about clinical study processes,
trial recruitment, and data quality.
PRE
I
CLINICAL TRIAL TIMELINE
Pre-Clinical/
Investigational
New Drug
Phase I Phase II Phase III Post-Phase III Post-Approval
PRE POSTI II III III+
12. PAGE 12
PAREXEL’s EPCU team provided the client a three-day workshop designed to illuminate clinical trial processes and
explain what makes each phase distinct. In addition, they supplied scientific advice for study design and created
an aggressive communication and recruitment plan to identify trial participants. PAREXEL’s innovative recruitment
plan, specifically, helped drive the client’s Phase I trial for treatment of an inflammatory disorder forward.
PAREXEL formulated a creative recruitment strategy to reach a large pool of potential trial participants in non-
traditional ways—through ads in public transit systems and text message alerts.
The Berlin EPCU’s recruitment innovations resulted in 138 healthy volunteers being enrolled within a 13-day
period and helped reduce the overall time for the post-clinical services (last subject, last visit to clinical
study report) by eight weeks.
Case 3 - Clinical Trial Costs Reduced Through Innovative Partnerships
and a Revised Trial Design
Location of Case: Global
Company Featured: PPD
Innovation Example: Innovative Trial Design, Collaborative Innovation, Innovative
Partnerships
Global contract research organization and ACRO member PPD is currently
collaborating with an international group of key opinion leaders, the United
States FDA, and Berry Consultants to design a Phase II screening trial for
novel treatments (including novel-novel combinations) in a metastatic
solid tumor.
This “next generation” I-SPY design will test therapies from multiple sponsors
in a single study. The design includes a shared control arm, tests first- and
second-line treatment as well as the impact of sequencing of treatments, and
explores anti-tumor activity by biomarker subsets.
At a recent meeting with the FDA, no major challenges to the design of the trial were raised. A reduction in the
number of patients exposed to ineffective standard therapy and a 30 percent or greater decrease in per patient
trial costs are among the benefits of this collaborative trial design.
Case 4 - Innovative Partnerships Put Cardiovascular Treatment Trial One Year
Ahead of Schedule
Location of Case: USA
Company Featured: Covance
Innovation Example: Innovative Partnerships/Collaborative Innovation
ACRO member Covance partnered closely with its trial sponsor and a top academic research organization (ARO)
to conduct a 10,000+ patient mega-trial of a drug designed to minimize cardiovascular risks for patients. The
forward-thinking partnership accelerated trial completion, ensured the inclusion of the right patients—those who
would most benefit from a new therapy—and safeguarded those patients’ wellbeing.
The partner ARO had a comprehensive understanding of the physician and patient needs present in this trial and
used its voice to advocate on their behalf throughout the trial. Covance applied insights from the partner ARO to
inform trial design and protocols, minimizing the burden on patients.
II
II III
Average Number of
Clinical Trial Participants:
• Phase I - 26 participants
• Phase II - 92 participants
• Phase III - 399 participants
• Phase IV - 772 participants
13. PAGE 13
Covance’s clinical operations expertise and its collaborative partnership with the ARO and trial sponsor led to its
complex trial, conducted with more than 10,000 patients, beginning three months ahead of schedule, with the
last patient starting treatment 12 months ahead of schedule. Completing benchmarks close to one year ahead of
schedule helps make it more likely for the cardiovascular treatment studied in this trial to get to market faster for
the patients who need it.
Case 5 - CRO-Championed Innovation Leads to Early Completion for Global Study of
Rare Pediatric Condition
Location of Case: Global
Company Featured: INC Research
Innovation Example: Collaborative Innovation/Innovative Partnerships/Logistics
ACRO member INC Research was contracted to manage a global trial for a rare pediatric neurological disorder. The
condition being studied was so rare, in fact, that finding enough eligible trial participants—ages seven to 17—in
a less than 12-month enrollment period posed a tremendous challenge for INC Research and its trial sponsor. In
addition, since individuals who met the study’s strict criteria were located around the world, the trial would have
to be conducted at more than 130 sites in 15 countries across North America, Eastern and Western Europe, and
Latin America.
Making the trial goals even harder to reach, a protocol amendment was issued after many Institutional Review
Board and Ethics Committee submissions had been made from sites around the globe. Immediately, INC Research
had to identify which sites needed to submit again for IRB review and how this would play into trial timeline and
enrollment end dates.
Completing trials on time and within budget requires innovative teamwork, especially where rare conditions are
concerned and when protocol amendments go into effect. Examples of innovative partnerships can be found
throughout this INC Research study.
INC Research conducted aggressive start-up and recruitment programs for this particular trial in tandem.
Identifying potential participants and connecting them to test sites was critical. To do so in limited time, INC
Research partnered with a travel agency to arrange travel and accommodation for subjects. Removing
logistical barriers for participants made the trial much more attractive to those living more than 50 miles from a
participating site.
INC’s Database Review Campaign was involved in trial recruitment to identify potential high-quality
participants. INC maintained close engagement with trial sites in the recruitment process and beyond,
providing sites with weekly status updates and keeping them engaged through a variety of motivational activities.
Every time a site screened or recruited a subject, they were thanked by handwritten card, personal phone call,
or an appreciative message.
INC Research collaborated closely with its trial sponsor at all points in the study to achieve immediate buy-in
from every single participating site team. Weekly meetings were held with the sponsor’s legal department, and the
sponsor even attended all site initiation visits, many of which were carried out by the sponsor’s Medical Monitor.
Sponsor involvement at the onset of the trial helped physician investigators quickly resolve any concerns about
trial protocols and procedures and establish a connection with the study team’s executive management.
Because of INC’s early involvement and collaboration with sites, the trial sponsor, and travel agencies, quality
subjects were identified early. First Site Initiated, First Subject Screened, First Subject Enrolled, and First
Subject Completed metrics all beat projections. Screening and enrollment beat expectations by six weeks
and the trial completed successfully ahead of schedule.
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Case 6 - Adaptive Trial Design Cuts Costs for Cancer Study by More Than $1 Million
Location of Case: USA
Company Featured: PPD
Innovation Example: Innovative Trial Design (Adaptive), Optimizing Trial Design for Each
Unique Trial and Set of Objectives
ACRO member PPD applied its Protocol Optimization service to a client’s Phase III study of a first-line treatment
for an adult solid tumor. Protocol Optimization leverages PPD’s medical and regulatory expertise, access to a
variety of data sources, and the application of novel analysis tools to evaluate and optimize trial designs for
clients throughout the course of a trial. Recognizing that each trial and each set of trial objectives are unique and
may require highly customized designs, PPD uses Protocol Optimization to implement adaptive trial designs in
real time.
As the Protocol Optimization process was applied in this cancer trial, study assessments not demonstrably linked
to study objectives were removed and the trial design was adapted to include a run-in dose finding stage and an
earlier interim analysis than originally proposed.
The adaptive trial design, made possible through Protocol Optimization, led to a savings of $1.2 million and
an accelerated timeline for establishing a go/no go decision in this particular cancer trial.
Case 7 - Innovative Partnerships Breed Success in Clinical Trials:
Clinical Trial Educators Program
Location of Case: USA
Company Featured: inVentiv Health Clinical
Innovation Example: Innovative Partnerships, Innovation in Patient Recruitment,
Collaborative Innovation
A company developing an injectable urology treatment was in trouble. Six months into its Phase III recruitment
period, the company had enrolled fewer than 100 of the 1,200 patients needed to complete its study. The company
turned to ACRO member inVentiv Health Clinical for help. inVentiv Health Clinical’s Clinical Trial Educators (CTEs)
program saved the company’s trial by helping to enroll more than 1,100 patients in less than 12 months.
inVentiv Health Clinical’s team of Clinical Trial Educators, many of whom are nurses with disease-specific
experience, visited the 60 U.S. trial sites and performed diagnostic analyses to determine why each was struggling
to enroll participants. Based on the site visits, the CTE team lead recommended an overall strategy and even site-
specific actions to turn things around and drive enrollment.
Over the course of the enrollment period, the CTEs shared best practices with each other, applied them to other
sites, and updated the trial sponsor in weekly conference calls. CTEs additionally supported trial sites in the
following ways:
• CTEs re-educated site staff on the study protocol.
• CTEs served as morale boosters, keeping the trial top-of-mind and motivating sites.
• CTEs provided advice and assistance in recruiting, including supporting community outreach at patient fairs
and advocacy groups.
• CTEs monitored progress and reviewed metrics with each site.
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CTEs play a helping role to trial sites as hand-holders, champions, and advisors. According to inVentiv Health
Clinical, “As peers, [CTEs are] able to build a relationship with study personnel that pays dividends.”
In this particular trial, the sponsor company’s Director of Clinical Operations said, “The CTE team was integral to
the success of our study.”
Case 8 - Innovations in Data Management and Strategic Partnerships Achieve Cost-
Savings for Biopharmaceutical Trial Sponsor
Location of Case: Global
Company Featured: inVentiv Health Clinical
Innovation Example: Innovation in Data Management (data optimizing software),
Innovative Partnerships
A global biopharmaceutical company wanted to improve the way it managed clinical trial data and consolidate
its data management activities. To efficiently enhance its data processes and activities, the sponsor turned to
inVentiv Health’s Clinical segment for help.
Through a strategic partnership, the sponsor—a long-term inVentiv Health Clinical client—sought to:
• Reduce fixed costs
Similar to other organizations in the biopharmaceutical industry, the sponsor needed to reduce costs,
particularly fixed costs such as those related to data management.
• Move to a deliverables-based model
A deliverables-based model, in which the sponsor would pay vendors only for the actual cost of deliverables,
was needed to help the sponsor keep spending to budgeted levels.
• More efficiently manage data from clinical trials
The company believed that improving clinical data management process efficiencies would help expedite
data delivery and enable more adaptive trial designs.
• Avoid disruptions to the portfolio
To avoid any disruptions to the sponsor’s portfolio, the sponsor needed a trusted partner with the right
expertise and a well thought out plan for a seamless transition.
• Maintain high standards
More than anything else, the sponsor wanted to ensure excellence in its standards for clinical
data management.
By overseeing all trial-level clinical data management work, inVentiv Health Clinical freed up the sponsor
company’s internal study team to focus on therapeutic and compound-level work, as well as other core
competencies and business objectives.
The partnership with the inVentiv Health Clinical helped the biopharmaceutical sponsor obtain expected ROI of
94 percent and a 14-month payback. Pleased with the results, the company awarded inVentiv Health Clinical its
global supplier of excellence award.
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Case 9 - Clinical Trial Innovations Expedite Recruitment, Prioritize Communication,
and Streamline Logistics for a Global COPD Trial
Location of Case: Global
Company Featured: PAREXEL
Innovation Example: – Innovation in Trial Recruitment, Innovation in Communication,
Innovation in Streamlining Logistics
Patient recruitment, extensive equipment requirements, and consistent data quality were major challenges for
global Phase II and Phase III Chronic Obstructive Pulmonary Disease (COPD) trials managed by ACRO
member PAREXEL.
More than 200 other COPD trials were underway at the same time, competing with PAREXEL’s studies for sites
and patients. PAREXEL took an integrated approach to overcoming trial challenges and was able to achieve
recruitment goals, database lock, and study completion substantially ahead of schedule—Phase III
recruitment, in particular, wrapped 2.5 months early. The overall COPD project finished 10 percent under
budget, and based on study performance and results, its sponsor was able to submit regulatory filings months
ahead of schedule.
Below are details of the innovative recruitment methods, communication strategies, and logistical coordination
successfully employed by PAREXEL in these global COPD trials:
• Innovation in Recruitment – Given the competitive environment to recruit patients for these particular
COPD trials, PAREXEL roughly doubled the number of trial sites to be used for qualification visits and planned
for an additional 25 percent more backup sites. All site initiation visits in a country were scheduled carefully
to conclude within 30 days of the first visit in that country. As a result, recruitment for both of the studies was
completed well ahead of schedule.
• Innovative Communication – Achieving cost efficiencies across multiple studies requires ongoing
communication between the sponsor, trial sites, and service providers to exchange best practices and
implement adaptive trial designs.
In addition to expanding the number of sites needed for initial participant recruitment, PAREXEL launched
a communications program between project leaders, functional leaders, and clinical research associates
(CRAs) to identify which recruitment approaches worked best, re-use and adapt study documents, and share
information through each step of the trial process.
PAREXEL implemented a preemptive Corrective Action/Preventative Action program to identify potential
issues at sites early and proactively address them before they could develop into problems that could impact
trial deadlines or jeopardize study results.
PAREXEL used its integrated eClinical technology platform to provide transparency with respect to data
collected. A client interface was built in PAREXEL’s IMPACT® CTMS to share real-time data with the sponsor,
allowing them to track trial results, progress, and trends.
• Logistical Innovation – COPD trials involve Spirometry. Because the consistency of data from Spirometry
testing depends a great deal on the quality of equipment used and the skill of the equipment operator,
PAREXEL provided Spirometry equipment to every trial site, implemented an extensive training program
for site personnel, and developed detailed testing procedures to ensure consistent, high-quality results
throughout both COPD studies.
PAREXEL supplied and coordinated delivery of key study equipment as well. Equipment was gathered by
PAREXEL and packaged into a single shipment for each site. This approach accelerated implementation of the
technology needed to conduct the study and saved each site approximately two weeks in waiting time.
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Case 10 – Bringing Treatments to Market Through CRO-Supported
Commercial Infrastructure
Location of Case: USA
Company Featured: Quintiles
Innovation Example: Innovative Partnerships, Innovation in Commercializing Treatments
An EU-based biotech company – with both clinical and commercial operations in Europe and in Asia – needed to
establish the commercial infrastructure necessary to support its new in-licensing strategy and bring products to
market in the United States. To mitigate risk and avoid the full expense of building a commercial arm from the
ground up, the company turned to ACRO member Quintiles for a partnership solution.
Quintiles put its market, regulatory, and drug safety expertise to work on behalf of the biotech company and
developed a U.S. commercial arm – run by Quintiles but reflecting the look and feel of the partner company –
complete with an 18-person team dedicated to managing all medical, commercial, and trade activities associated
with bringing two of the partner company’s products to market domestically.
In the year after Quintiles began operating the biotech company’s U.S. commercial arm, year-over-year sales for
two separate products grew by more than 10 percent, exceeding the client’s expectations.
Case 11 - Making the Most of Data: Adopting eClinical Systems Allows CROs to Visually
Track Safety Data in Real-Time
Location of Case: USA
Company Featured: ICON
Innovation Example: Innovation in Data Tracking and Management, Innovation in
Trial Design, Adjudication
As clinical trials have expanded in size and duration to improve risk management and patient safety, the task
of preparing and analyzing data from clinical trials has become more complex. It’s more important than ever,
though, to find a way to sort, track, and interpret data as efficiently as possible, since that’s what’s required to
heighten productivity and get treatments to patients faster.
The confluence of growing volumes of clinical data with the heightened need for analytical speed and an industry-
wide mandate for greater efficiency is driving the development of better technology solutions. ACRO member
ICON is providing two such solutions through its ICONIK and MIRA software platforms.
A company faced with the task of monitoring outcomes for 9,340 patients in more than 30 countries used
ICONIK software, and its innovative data visualization tools, to track lab data in real time and automate processes
for managing case adjudication. The web-based ICONIK system helped the company manage, visualize, analyze,
and report on the 25-30 lab variables being monitored in the outcomes of its study.
On the choice to rely on real-time data tracking software, the company’s project director remarked, “It was
obvious that we could not do a proper job of monitoring the battery of lab parameters in such a broad
post-marketing trial using a largely manual, paper-based process. With each of the 9,340 patients in the study
having eight to fifteen scheduled medical visits and multiple lab parameters measured per visit, the volume of
information would explode very quickly. It would become impossible to make sense of it all without the aid of
interactive analytical tools.”
The use of advanced data analytic software in clinical trials leads to greater trial efficiency, real-time data analysis,
and stronger protocol and regulatory compliance. ICON’s dynamic data reporting tools are changing companies’
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approaches to trial surveillance. A Medical Director who recently used ICON’s software commented: “With it, you
can get involved in a discussion that inspires a scientific line of inquiry and then instantly have the answers.
I can challenge the data, looking at combinations of lab parameters and searching for trends in a way that I
could never do if I had to wait three weeks for a statistician to produce a graph for me. It matches the way I
think about data.”
Case 12 - Adaptive Trial Designs Maximize Trial Efficiency
Location of Case: EU, 9 countries
Company Featured: PPD
Innovation Example: Innovation in Trial Design (Adaptive), Collaborative Innovation
(with EMA)
ACRO member PPD was faced with the challenge to design a cost-effective trial to monitor the long-term safety
profile and signal of a client’s drug. The client’s original study design included a randomized trial that would enroll
1,000 patients at 100 sites in three separate regions (12 countries). The client had limited funding for the study and
asked PPD to propose an alternative scenario.
After reviewing data, PPD recommended a single-arm observational study with fewer countries, sites, and
patients. The revised study design sought to maximize efficiency throughout the trial and ultimately lowered trial
costs by 60 percent.
PPD’s revised trial design did the following:
• Decreased trial scope from three regions and 12 countries to one region and nine countries
• Reduced trial sites from 200 to 100
• Reduced enrollment to 500 patients as opposed to 1,000
• Reduced volume of case report forms from 30 to 20 pages per patient
• Reduced interim monitoring visits per site from 640 to 154
PPD successfully made the case to the European Medicines Agency (EMA) that sufficient comparator data had
already been collected in Phase III of the trial, thus ensuring adequate safety monitoring to protect patients.
PPD’s strategic contribution and trial redesign helped close the strategy and financial gap of executing a client’s
post-marketing commitment.
These cases showcase just a few of the many ways ACRO members are innovating
throughout the clinical trial process in order to get new treatments to patients faster.
Their work is powering 21st Century clinical research.
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ABOUT ACRO
The Association of Clinical Research Organizations (ACRO) represents companies that provide a variety of
specialized services that support the development of new pharmaceuticals, biologics, and medical devices.
The Association provides an active voice for the CRO industry globally. Through its member companies, ACRO
helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ more
than 100,000 professionals worldwide and research in 142 countries. For more information, please visit
www.acrohealth.org. Twitter @acrohealth. YouTube @ACROHealthChannel. Facebook. RebelMouse.
20. 915 15th Street, NW
Second Floor
Washington, DC 20005
Phone: 202-464-9340
Email: info@acrohealth.org