In this presentation, you'll get answers to these important questions that are having a big impact on improving oncology clinical trial performance in Canada. You will also see some real life stories about how the Reverse Feasibility Program is impacting patient outcomes:
1. How knowledge & relationships at Health Canada can remove bottlenecks and speed up the regulatory process;
2. How you can navigate ethics review boards more efficiently;
3. How a Master CTA template is speeding up site contract negotiations
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.
Key Strategies to Survive in Today\’s Changing World of Oncology Clinical TrialsRoberto Lara
This overview highlights the most critical issues affecting oncology clinical development in the U.S. biopharmaceutical industry To view the full webcast with audio please visit http:/www.scimega.com/resources-oncology-webcasts.php
- Patient recruitment for clinical trials is a major challenge, estimated to be a $1.2-1.8 billion market. Recruitment costs average 6% of trial costs and are a primary factor in delays.
- Less than 5% of patients are aware of clinical trials, and only 2-3% actually enroll. However, over 90% of participants have a positive experience and would participate again.
- There is significant opportunity to improve recruitment through more patient-centric approaches leveraging data, technology, and analytics to identify more eligible patients and improve the recruitment process. However, this will require changes to traditional models.
The Green Park Collaborative (GPC) has developed a new tool to help health care decision makers confidently and consistently use Real World Evidence (RWE) when making tough coverage and care choices. Called RWE Decoder, the spreadsheet-based assessment tool lets users review and evaluate all existing studies and evidence for both rigor and relevance. Informed by these factors, users can assess study quality, and generate a visual summary to help gauge the evidence under review.
Published RWE studies developed from data-rich electronic medical records or medical claims data are increasingly available from health care systems. However, the quality of this research can vary widely, and payers, clinicians and other health care decision makers often dismiss it out of hand. RWE Decoder and its associated user guide and framework, offer a thoughtful approach to helping these decision makers assess whether RWE studies address their questions and can appropriately guide their choices.
The tool, user guide, and supporting white paper are available here: https://goo.gl/AhbHUw
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 current system for evidence assessment in the United States is uncoordinated, with no single agency setting priorities and different organizations having varying objectives. Several initiatives have evolved to fill needs, such as the Drug Effectiveness Review Project which conducts reviews for state Medicaid programs. Prioritizing topics for systematic reviews is important due to scarce resources but major increases in funding and capacity may diminish the importance of prioritization in the future. The measure of success for any prioritization scheme is its usefulness to its intended audience.
Best Practices in Clinical Study RecruitmentCTSI at UCSF
This document discusses best practices in clinical study recruitment and retention. It covers:
1) Recruitment practices such as performing initial analyses of study design and site-specific factors, planning and budgeting for screen failures and protocol changes, and implementing a staged communication plan.
2) Retention practices like ensuring participants are well-informed, understanding their needs, and keeping communication open.
3) A proposed Participant Recruitment Service at UCSF to centralize recruitment efforts through activities like recruitment analysis, direct mailings to patient cohorts, and developing recruitment materials and resources.
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.
Key Strategies to Survive in Today\’s Changing World of Oncology Clinical TrialsRoberto Lara
This overview highlights the most critical issues affecting oncology clinical development in the U.S. biopharmaceutical industry To view the full webcast with audio please visit http:/www.scimega.com/resources-oncology-webcasts.php
- Patient recruitment for clinical trials is a major challenge, estimated to be a $1.2-1.8 billion market. Recruitment costs average 6% of trial costs and are a primary factor in delays.
- Less than 5% of patients are aware of clinical trials, and only 2-3% actually enroll. However, over 90% of participants have a positive experience and would participate again.
- There is significant opportunity to improve recruitment through more patient-centric approaches leveraging data, technology, and analytics to identify more eligible patients and improve the recruitment process. However, this will require changes to traditional models.
The Green Park Collaborative (GPC) has developed a new tool to help health care decision makers confidently and consistently use Real World Evidence (RWE) when making tough coverage and care choices. Called RWE Decoder, the spreadsheet-based assessment tool lets users review and evaluate all existing studies and evidence for both rigor and relevance. Informed by these factors, users can assess study quality, and generate a visual summary to help gauge the evidence under review.
Published RWE studies developed from data-rich electronic medical records or medical claims data are increasingly available from health care systems. However, the quality of this research can vary widely, and payers, clinicians and other health care decision makers often dismiss it out of hand. RWE Decoder and its associated user guide and framework, offer a thoughtful approach to helping these decision makers assess whether RWE studies address their questions and can appropriately guide their choices.
The tool, user guide, and supporting white paper are available here: https://goo.gl/AhbHUw
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 current system for evidence assessment in the United States is uncoordinated, with no single agency setting priorities and different organizations having varying objectives. Several initiatives have evolved to fill needs, such as the Drug Effectiveness Review Project which conducts reviews for state Medicaid programs. Prioritizing topics for systematic reviews is important due to scarce resources but major increases in funding and capacity may diminish the importance of prioritization in the future. The measure of success for any prioritization scheme is its usefulness to its intended audience.
Best Practices in Clinical Study RecruitmentCTSI at UCSF
This document discusses best practices in clinical study recruitment and retention. It covers:
1) Recruitment practices such as performing initial analyses of study design and site-specific factors, planning and budgeting for screen failures and protocol changes, and implementing a staged communication plan.
2) Retention practices like ensuring participants are well-informed, understanding their needs, and keeping communication open.
3) A proposed Participant Recruitment Service at UCSF to centralize recruitment efforts through activities like recruitment analysis, direct mailings to patient cohorts, and developing recruitment materials and resources.
Patient recruitment into clinical trials presentationBeshr Nammouz
Clinical trial managers recruit patients through two primary methods: pull and push. Pull involves physicians who are principal investigators referring their own patients. Push involves encouraging patients to find a particular investigator through advertisements in various media outlets like television, social media, and radio. Issues with patient recruitment and enrollment are the main causes of missed clinical trial timelines, which can cost companies millions of dollars in lost sales per day.
The document discusses an electronic clinical trial recruitment system that aims to address the problems of slow clinical research translation, labor-intensive and costly trial recruitment methods. It presents a solution of leveraging existing electronic medical record data across different healthcare systems and practices to more efficiently identify and enroll qualified patients for clinical trials in a networked system. The system could benefit research sponsors, investigators, medical practices, and patients by speeding recruitment times and lowering costs while improving clinical care engagement and outcomes. It analyzes the potential market opportunity and differentiation of this federated network approach to electronic clinical trial recruitment.
A presentation showcasing some of the patient recruitment challenges that I encountered as a recruitment manager as well as some of the strategies -- DIGITAL ADVERTISING -- I used to overcome them.
Mosio's Clinical Trial Patient Recruitment and Retention Ebook (First Edition)Mosio
The first edition of Mosio's patient recruitment and retention ebook contains 68 tips and examples from clinical research industry professionals on ways to improve efforts to recruit, retain and engage clinical trial patients.
To get access to a free download of the 2nd Edition, visit http://www.mosio.com/prebook
For more information on how you can improve patient engagement while increasing workflow efficiencies in communicating with study participants using two-way text messaging, please visit us at http://www.mosio.com
The document summarizes key themes from a webinar on developing medical policies and coverage guidelines for next generation sequencing in oncology. It discusses the challenges of evaluating genomic tests and gaining insurance coverage. Recommendations include requiring laboratories to obtain accreditation for analytic validity, covering small gene panels when clinical utility is established, and facilitating data collection to support coverage of larger tests and off-label drug use. The webinar included perspectives from various stakeholders on addressing these issues.
The high stakes of running an oncology clinical trialDavid Levin
Unlike other therapeutic trials, oncology trials are more sensitive in nature and require specific clinical expertise to properly manage. Many participants are required to have already undergone front and even second lines of therapy and only if these have failed are they eligible for the experimental and toxic drugs often required in oncology trials. Costs are high, enrollment can be challenging and you are often working with medically-fragile patients. However, when managed properly, effective oncology trials can save lives, generate new revenue streams and make breakthrough discoveries in a challenging therapeutic area.
This summary provides the key points from the document in 3 sentences:
The document discusses the importance of proactive planning for patient recruitment and retention in clinical trials to avoid costly delays. It notes that unforeseen factors can negatively impact enrollment and retention, so contingency plans should be in place. Effective planning involves analyzing potential barriers, partnering with community organizations, selecting sites and coordinators strategically, and having metrics to trigger contingency strategies if enrollment begins falling off track.
Patient centric site training to enhance clinical trial performancelmoench
In the quest to accelerate the clinical trial process, we involve patients as partners;
We obtain patient insights that are used to:
Fine tune aspects of the clinical protocol for compliance and adherence
Train sites on how to effectively communicate with patients about the clinical trial to increase recruitment rates
Prepare sites to manage patient expectations about clinical trial participation to increase retention rates
We conduct dynamically facilitated Study Seminars that prepare sites for the patient encounter
We have measurable results: Study sites that participate in patient-centric Study Seminars will perform at a higher rate for patient recruitment and retention
The document discusses several secular trends in healthcare, including the shift towards value-based reimbursement models, increasing consumerism, and rapid advancements in technology and use of big data. Major trends include growing consolidation across healthcare sectors, 50% of Medicare payments transitioning to value-based models by 2018, a large increase in high deductible health plans, and billions in investments in digital health, technology, and analytics.
The document discusses effective pathways for late-stage biosimilar clinical trials. It outlines strategies for optimizing patient recruitment and retention, leveraging data-driven monitoring, and enhancing operational efficiencies. Specific considerations include understanding regulatory environments, selecting appropriate reference products and clinical endpoints, identifying qualified investigator sites, and employing risk-based monitoring approaches using data surveillance technologies. The presentation emphasizes that innovative trial designs and leveraging data-driven approaches will be important to efficiently reach biosimilar approval in the intensifying race to launch new products.
KCR Patient Recruitment & Retention case study: Pediatric PainKCR
The study experienced recruitment problems, delaying the project timeline. To address this, KCR implemented a rescue strategy including feasibility studies to select optimal sites, extensive training, and an experienced study team. An in-depth risk assessment was conducted to mitigate issues like pediatric pain scales and consent. Careful site selection focusing on pediatric surgery departments successfully enrolled 53 patients within timeline. The sponsor expressed confidence in KCR and awarded them an even more challenging pediatric study.
Patient recruitment and retention in clinical trials is recognized as a major challenge. Over 80% of trials fail to enroll on time due to difficulties recruiting the required number of suitable patients. Recruitment strategies are often not considered early enough in the trial planning process. Effective recruitment requires realistic timelines, adequate budgets, and the use of multiple recruitment methods like investigator databases, clinician referrals, advertisements, and community outreach. Maintaining open communication with patients and providing convenience are important for retention. Recent approaches to improve recruitment include using professional recruitment providers, market research, informatics, and centralized recruiting systems.
Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?CTSI at UCSF
Presentation by Laurie Herraiz, RD, CCRP in May 2012 at CHR sponsored workshop on UCSF Campus. Topics include, basics of regulatory and recruitment, iMedrRIS application instructions, waivers of consent/authorization for recruitment purposes, examples of approved recruitment materials, and common challenges to recruitment.
The document discusses developing a pilot project for coverage with evidence development (CED) in the private sector. A stakeholder workgroup selected pharmacogenetic testing for estimating initial warfarin dosing as the topic. The workgroup discussed operational and study design issues, such as coverage models, communication with patients and providers, funding, and informed consent. Conducting private sector CED poses challenges but payers remain interested to generate better information for coverage decisions through this mechanism.
Placebo and Standard of Care Data Sharing Initiative - PSoC Data SharingTransCelerate
This document outlines 7 potential use cases for sharing clinical trial data across pharmaceutical companies. The use cases are: 1) Enhanced safety signal interpretation, 2) Reduced size of the control arm, 3) Precision powering by minimizing missing data, 4) Inclusion/exclusion criteria optimization, 5) Model-based enhanced trial design, 6) Clinical feasibility optimization by understanding geographic influences, and 7) Biomarker development. For each use case, the document discusses the potential impact, applications, scope, and enhancements over usual practices.
Impacting Recruitment from a Sponsor / CRO PerspectiveFraser Gibson
As presented at the SoCRA ( Society of Clinical Research Associates) Global Conference in October 2016 by Fraser Gibson.
This slideshow looks at the current state of patient recruitment in the clinical research industry. We then proposes a series of solutions that sponsors may considering implementing in order to positively impact the recruitment rates into their clinical trial.
Advantage Clinical provides online education and training in the clinical research industry. Visit www.advantage-clinical.com to learn more about our clinical research education and training courses.
The document discusses a survey conducted at Ohio State University's Comprehensive Cancer Center to improve the process of activating clinical trials. The survey aimed to understand pharmaceutical sponsors' experiences and identify areas for improvement. It found the top strengths were staff professionalism and explanation of roles. The top weaknesses were communication of trial progress, length of activation process, and timeliness of communications. Recommendations to address these weaknesses included using online collaboration tools, setting communication guidelines, and designating direct contacts. Implementing these changes could help provide sponsors more informed trial status updates and clearer, faster communication.
Global Clinical Trials: Best Practices & Common PitfallsImperial CRS
This document discusses best practices and common pitfalls to avoid when planning and conducting global clinical trials. It identifies key factors to consider such as study feasibility, regulatory requirements, site selection, and patient recruitment. Specific pitfalls addressed include unrealistic protocol design, poor planning, incomplete feasibility data, lack of customized recruitment strategies, and inadequate consideration of local regulatory, cultural and logistical factors. The importance of leveraging local expertise and collecting metrics to guide a data-driven approach is emphasized. A case study example illustrates how challenges can reshape a study's scope and timeline.
Tricks of the Trade: Patient Recruitment & Retention for Different Study TypesImperial CRS
In efforts to raise the bar for medical advancement, clinical trials are growing increasingly complex. This complexity, more often than not, leads to costly delays in enrollment. In this ebook, we'll take a look at 4 case studies for different study types, and examine the unique factors to consider during planning.
Patient recruitment into clinical trials presentationBeshr Nammouz
Clinical trial managers recruit patients through two primary methods: pull and push. Pull involves physicians who are principal investigators referring their own patients. Push involves encouraging patients to find a particular investigator through advertisements in various media outlets like television, social media, and radio. Issues with patient recruitment and enrollment are the main causes of missed clinical trial timelines, which can cost companies millions of dollars in lost sales per day.
The document discusses an electronic clinical trial recruitment system that aims to address the problems of slow clinical research translation, labor-intensive and costly trial recruitment methods. It presents a solution of leveraging existing electronic medical record data across different healthcare systems and practices to more efficiently identify and enroll qualified patients for clinical trials in a networked system. The system could benefit research sponsors, investigators, medical practices, and patients by speeding recruitment times and lowering costs while improving clinical care engagement and outcomes. It analyzes the potential market opportunity and differentiation of this federated network approach to electronic clinical trial recruitment.
A presentation showcasing some of the patient recruitment challenges that I encountered as a recruitment manager as well as some of the strategies -- DIGITAL ADVERTISING -- I used to overcome them.
Mosio's Clinical Trial Patient Recruitment and Retention Ebook (First Edition)Mosio
The first edition of Mosio's patient recruitment and retention ebook contains 68 tips and examples from clinical research industry professionals on ways to improve efforts to recruit, retain and engage clinical trial patients.
To get access to a free download of the 2nd Edition, visit http://www.mosio.com/prebook
For more information on how you can improve patient engagement while increasing workflow efficiencies in communicating with study participants using two-way text messaging, please visit us at http://www.mosio.com
The document summarizes key themes from a webinar on developing medical policies and coverage guidelines for next generation sequencing in oncology. It discusses the challenges of evaluating genomic tests and gaining insurance coverage. Recommendations include requiring laboratories to obtain accreditation for analytic validity, covering small gene panels when clinical utility is established, and facilitating data collection to support coverage of larger tests and off-label drug use. The webinar included perspectives from various stakeholders on addressing these issues.
The high stakes of running an oncology clinical trialDavid Levin
Unlike other therapeutic trials, oncology trials are more sensitive in nature and require specific clinical expertise to properly manage. Many participants are required to have already undergone front and even second lines of therapy and only if these have failed are they eligible for the experimental and toxic drugs often required in oncology trials. Costs are high, enrollment can be challenging and you are often working with medically-fragile patients. However, when managed properly, effective oncology trials can save lives, generate new revenue streams and make breakthrough discoveries in a challenging therapeutic area.
This summary provides the key points from the document in 3 sentences:
The document discusses the importance of proactive planning for patient recruitment and retention in clinical trials to avoid costly delays. It notes that unforeseen factors can negatively impact enrollment and retention, so contingency plans should be in place. Effective planning involves analyzing potential barriers, partnering with community organizations, selecting sites and coordinators strategically, and having metrics to trigger contingency strategies if enrollment begins falling off track.
Patient centric site training to enhance clinical trial performancelmoench
In the quest to accelerate the clinical trial process, we involve patients as partners;
We obtain patient insights that are used to:
Fine tune aspects of the clinical protocol for compliance and adherence
Train sites on how to effectively communicate with patients about the clinical trial to increase recruitment rates
Prepare sites to manage patient expectations about clinical trial participation to increase retention rates
We conduct dynamically facilitated Study Seminars that prepare sites for the patient encounter
We have measurable results: Study sites that participate in patient-centric Study Seminars will perform at a higher rate for patient recruitment and retention
The document discusses several secular trends in healthcare, including the shift towards value-based reimbursement models, increasing consumerism, and rapid advancements in technology and use of big data. Major trends include growing consolidation across healthcare sectors, 50% of Medicare payments transitioning to value-based models by 2018, a large increase in high deductible health plans, and billions in investments in digital health, technology, and analytics.
The document discusses effective pathways for late-stage biosimilar clinical trials. It outlines strategies for optimizing patient recruitment and retention, leveraging data-driven monitoring, and enhancing operational efficiencies. Specific considerations include understanding regulatory environments, selecting appropriate reference products and clinical endpoints, identifying qualified investigator sites, and employing risk-based monitoring approaches using data surveillance technologies. The presentation emphasizes that innovative trial designs and leveraging data-driven approaches will be important to efficiently reach biosimilar approval in the intensifying race to launch new products.
KCR Patient Recruitment & Retention case study: Pediatric PainKCR
The study experienced recruitment problems, delaying the project timeline. To address this, KCR implemented a rescue strategy including feasibility studies to select optimal sites, extensive training, and an experienced study team. An in-depth risk assessment was conducted to mitigate issues like pediatric pain scales and consent. Careful site selection focusing on pediatric surgery departments successfully enrolled 53 patients within timeline. The sponsor expressed confidence in KCR and awarded them an even more challenging pediatric study.
Patient recruitment and retention in clinical trials is recognized as a major challenge. Over 80% of trials fail to enroll on time due to difficulties recruiting the required number of suitable patients. Recruitment strategies are often not considered early enough in the trial planning process. Effective recruitment requires realistic timelines, adequate budgets, and the use of multiple recruitment methods like investigator databases, clinician referrals, advertisements, and community outreach. Maintaining open communication with patients and providing convenience are important for retention. Recent approaches to improve recruitment include using professional recruitment providers, market research, informatics, and centralized recruiting systems.
Basic Study Recruitment and Regulatory Issues: Which Methods are Appropriate?CTSI at UCSF
Presentation by Laurie Herraiz, RD, CCRP in May 2012 at CHR sponsored workshop on UCSF Campus. Topics include, basics of regulatory and recruitment, iMedrRIS application instructions, waivers of consent/authorization for recruitment purposes, examples of approved recruitment materials, and common challenges to recruitment.
The document discusses developing a pilot project for coverage with evidence development (CED) in the private sector. A stakeholder workgroup selected pharmacogenetic testing for estimating initial warfarin dosing as the topic. The workgroup discussed operational and study design issues, such as coverage models, communication with patients and providers, funding, and informed consent. Conducting private sector CED poses challenges but payers remain interested to generate better information for coverage decisions through this mechanism.
Placebo and Standard of Care Data Sharing Initiative - PSoC Data SharingTransCelerate
This document outlines 7 potential use cases for sharing clinical trial data across pharmaceutical companies. The use cases are: 1) Enhanced safety signal interpretation, 2) Reduced size of the control arm, 3) Precision powering by minimizing missing data, 4) Inclusion/exclusion criteria optimization, 5) Model-based enhanced trial design, 6) Clinical feasibility optimization by understanding geographic influences, and 7) Biomarker development. For each use case, the document discusses the potential impact, applications, scope, and enhancements over usual practices.
Impacting Recruitment from a Sponsor / CRO PerspectiveFraser Gibson
As presented at the SoCRA ( Society of Clinical Research Associates) Global Conference in October 2016 by Fraser Gibson.
This slideshow looks at the current state of patient recruitment in the clinical research industry. We then proposes a series of solutions that sponsors may considering implementing in order to positively impact the recruitment rates into their clinical trial.
Advantage Clinical provides online education and training in the clinical research industry. Visit www.advantage-clinical.com to learn more about our clinical research education and training courses.
The document discusses a survey conducted at Ohio State University's Comprehensive Cancer Center to improve the process of activating clinical trials. The survey aimed to understand pharmaceutical sponsors' experiences and identify areas for improvement. It found the top strengths were staff professionalism and explanation of roles. The top weaknesses were communication of trial progress, length of activation process, and timeliness of communications. Recommendations to address these weaknesses included using online collaboration tools, setting communication guidelines, and designating direct contacts. Implementing these changes could help provide sponsors more informed trial status updates and clearer, faster communication.
Global Clinical Trials: Best Practices & Common PitfallsImperial CRS
This document discusses best practices and common pitfalls to avoid when planning and conducting global clinical trials. It identifies key factors to consider such as study feasibility, regulatory requirements, site selection, and patient recruitment. Specific pitfalls addressed include unrealistic protocol design, poor planning, incomplete feasibility data, lack of customized recruitment strategies, and inadequate consideration of local regulatory, cultural and logistical factors. The importance of leveraging local expertise and collecting metrics to guide a data-driven approach is emphasized. A case study example illustrates how challenges can reshape a study's scope and timeline.
Tricks of the Trade: Patient Recruitment & Retention for Different Study TypesImperial CRS
In efforts to raise the bar for medical advancement, clinical trials are growing increasingly complex. This complexity, more often than not, leads to costly delays in enrollment. In this ebook, we'll take a look at 4 case studies for different study types, and examine the unique factors to consider during planning.
The document discusses the importance of early clinical recruitment planning for drug development programs. It notes that delays in recruitment can significantly increase costs and impact revenue opportunities due to later market entry. Early planning allows consideration of factors like disease characteristics, enrollment population size, competition, and protocol challenges that influence feasibility. Comprehensive recruitment programs costing 1-12% of delay costs can help avoid delays and ensure timely trial completion and drug approval.
Tricks of the trade: Turn Around Your Slow-Enrolling TrialImperial CRS
Common factors behind slow enrollment
Creating a plan of attack
Setting realistic expectations
Getting management on board
Energizing sites and other stakeholders
Execution and performance tracking
1. There is a shortage of qualified Clinical Research Associates (CRAs) to monitor clinical trials due to increased outsourcing of trials to CROs and a lack of CRA talent development. This has led to rising costs and extended timelines for sponsors.
2. One solution is for CROs to invest in developing their own CRA talent through a lengthy training program that includes classroom instruction, simulation exercises, apprenticeships, and mentorship opportunities to gain experience.
3. This allows new recruits to learn in a controlled environment before independently monitoring trials, building their skills and confidence over 6 months. Graduates of such programs have higher retention rates than experienced CRAs.
1. There is a shortage of qualified Clinical Research Associates (CRAs) to monitor clinical trials due to increased outsourcing of trials to CROs and a lack of CRA talent development. This has led to rising costs and extended timelines for sponsors.
2. One solution is for CROs to invest in developing their own CRA talent through a lengthy training program that includes classroom instruction, simulation exercises, apprenticeships, and mentorship opportunities to gain experience.
3. This allows new recruits to learn in a controlled environment before independently monitoring trials, building their skills and confidence over 6 months. Graduates of such programs have higher retention rates than experienced CRAs.
The document discusses the evolution of medical science liaison (MSL) teams from the 1980s to present day. It describes how MSL teams initially focused on post-marketing activities but now also contribute value to clinical drug development processes like trial design and identification of new indications. The document provides examples of how MSL teams have helped pharmaceutical companies gain regulatory approval faster, lower development costs, and increase drug revenues.
Understanding patient and stakeholder needs alongside the patient journey - ...د حاتم البيطار
The initiative aimed to understand patient needs along their journey and co-develop solutions. Stakeholders' needs were collected and prioritized to identify important needs. A solution was co-created and tested, but the project was stopped due to prioritization of another solution. However, insights could still be used. The process provided understanding of patient needs and potential impactful solutions, though final implementation faces challenges. Involving stakeholders throughout provided different perspectives that aided prioritization.
This document provides information about an upcoming webinar on funding algorithms for cancer treatments. It includes:
1. Details about the webinar date, time, and topic on what goes into decisions about accessing cancer treatments across different lines of treatment.
2. A list of the webinar panel speakers and moderator.
3. Instructions for how to submit questions during the webinar.
4. Background on the development of funding algorithms by CADTH to determine placement of new cancer therapies compared to existing treatments and impacts on access.
5. Details of CADTH's current algorithm process, which aims to improve on the previous process by considering more clinical evidence and allowing for manufacturer, clinician
USA Commercial Strategy, Medical Devices, National Technology Transfer Confer...Debra A. Chanda
This document discusses financing trends in the medical device industry and strategies for US commercialization of medical devices. It notes that venture capital funding and deal activity declined in recent quarters, forcing companies to seek alternative financing from angels, crowdfunding, and strategic partners. The document provides examples of recent funding rounds for medical device companies and outlines strategies for developing regulatory and commercialization plans that address clinical needs and reimbursement pathways. It emphasizes the importance of strong operational management to execute business plans and stresses that investors fund management teams rather than just technologies.
The Secret to Successful Early Phase Study Expansions in CanadaRoberto Lara
Find out why cutting-edge science and a well-designed protocol are not enough and why the Canadian regulatory and ethics review process is not as complicated as you may think.
The document discusses clinical trials and subjects. It emphasizes that behind every successful clinical trial are thousands of subjects. It highlights the important role and responsibilities of subjects in clinical trials. It also discusses challenges in subject compliance and retention, and provides some solutions sites can implement, such as education, training, relationship building, and sensitization of subject responsibilities. The document advocates for including vulnerable populations in clinical trials.
Defining your role in patient experience aamc-gia presesentationEndeavor Management
Want to learn how marketing gains a seat at the table in the patient experience? This presentation with MD Anderson and Vanderbilt provides some great tips.
Improving capacity and quality can help future ready your programGenpact Ltd
The last four decades have seen survival rates for most major cancers markedly improve even as incidence rates have climbed. Such progress is widely attributed to an increased focus on early detection and intervention, particularly with cancers deemed highly “curable” if detected early. Also, many more end-stage cancers today are being rendered manageable for years or even decades, where previous generations of patients with similar diagnoses were given significantly shorter prognoses. With this success comes a host of new needs, mainly in the form of capacity and quality. Timely, affordable, quality care is the great challenge ahead. If this challenge is to be adequately met, community cancer centers need to play a greater role than ever.
A challenging market to engage - a case study of General Practitioners and an...Kai Meischke
The document describes a case study where an online community of GPs was used to conduct market research for a pharmaceutical company over six months. GPs were recruited from an existing panel and the community allowed both qualitative and quantitative research activities to be run quickly. Engagement was initially high but slowed over time. Keeping new content coming and clients engaged with the agile process was challenging but provided insights for a brand extension launch.
Annual ed performance improvement.4 2010capstonerx
This document discusses performance improvement in healthcare. It outlines how opportunities for improvement are identified through patient satisfaction surveys, staff input, chart reviews, and other means. Priorities are set annually and focus on clinical care quality, patient/employee satisfaction, and financial performance. The Plan-Do-Check-Act (PDCA) cycle is used to test changes. Staff are encouraged to submit improvement ideas. Performance improvement differs from research in that the former aims to improve local processes while research seeks generalizable knowledge. Reducing catheter-associated urinary tract infections is provided as an example project using the PDCA framework.
Tools to Drive Enrollment OCT Arena-Boston-2015Dan Diaz
The 4th Annual Clinical Operations in Oncology Trials East Coast was an amazing hit. Over 25 speakers challenged the 200 attendees on how- "WE" as an industry can use new tools and strategies to better our Clinical Trial Execution and Patient Enrollment.
With only 3% of the patients in the USA participating in Cancer Trials- we have to do a better job finding ways to educate them about the benefits of clinical studies.
The following tools are some of the new enhancements for better site and physician selection which can help find better results.
2015-11 Mary Syto CTS SoCal Challenges in Global Supply Mgmt in Small BiotechMary Syto
Overcoming the Challenges of Global Supply Chain Management at a Small Biotech discusses the challenges a small biotech faces in managing their global clinical supply chain. Some key challenges include limited in-house staff and expertise, high reliance on third party partners and vendors, and tight budgets and timelines. The document provides tips for small biotechs in selecting qualified clinical supply partners, establishing good communication strategies, and managing relationships with partners. It emphasizes getting clinical supply involved early in protocol development to help mitigate risks.
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- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Our backs are like superheroes, holding us up and helping us move around. But sometimes, even superheroes can get hurt. That’s where slip discs come in.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
What Your CRO Doesn't Know Could Hurt You
1. What your cro doesn’t
Know could hurt you
How to leverage Canada
for Study Expansion &
Recruitment
2.
3. Patient 001 – ADC
This
pa(ent
was
diagnosed
with
Mul(ple
Myeloma
in
2002.
A
pharmacist
by
training,
he
was
highly
educated
and
well
aware
of
his
chances
for
survival
and
the
limited
treatment
op(ons
that
were
available
at
the
(me.
He
asked
his
oncologist
about
par(cipa(ng
in
a
clinical
trial
but
was
informed
there
was
only
one
available.
He
eagerly
signed
on,
but
was
randomized
to
the
control
arm.
4. It’s
stories
like
these
that
give
meaning
to
what
we
do
and
why
we
are
so
passionate
about
our
mission,
which
is
to
aDract
cu$ng-‐edge
oncology
trials
to
Canada
and
to
connect
sponsors
with
a
network
of
highly
mo(vated
inves(gators
and
their
pa(ents.
Scimega’s mission:
5. A
Look
Under
The
Hood
of
the
Reverse
Feasibility
Program
-‐
REB
Strategy
-‐
Site
Contract
Execu(on
-‐
Regulatory
Strategy
Keys
to
AcceleraAng
Site
Performance
Real-‐life
Canadian
Expansion
Success
Stories
&
Results
summary
8. What are
investigators
looking for?
The
ques(ons
we
seek
to
answer
oMen
revolve
around
how
we
can
help
aDract
more
oncology
trials
that
would
be
successful
in
Canada.
Selling
the
idea
of
a
niche
CRO
that
is
100%
dedicated
to
oncology
is
not
the
hard
part.
Everyone
can
understand
the
value
in
that.
The
true
challenge
lies
in
how
to
sell
Canada
-‐
a
region
well
known
for
its
data
quality,
but
not
usually
recognized
for
its
speed.
The
key
has
been
to
understand
what
drives
enrolment.
In
other
words,
to
understand
what
inves(gators
are
looking
for!
9. Why
some
trials
just
seem
to
run
by
themselves?
?
Why
some
inves(gators
just
seem
to
“get
the
science”
and
grasp
the
urgency
of
one
program
but
not
another?
?
To do so we need
To understand:
Meanwhile:
Others
just
go
through
the
mo(ons
and
don't
seem
very
mo(vated…
10. sTEP 1a
Con(nuous
survey
of
Canadian
inves(gator
needs
and
interests
We
start
by
reaching
out
to
our
Reverse
Feasibility
Champions
and
asking
them
to
provide
us
with
their
preferences
in
terms
of
compounds,
indica(ons
and
lines
of
therapy.
We
do
this
on
a
regular
basis.
12. 1csTEP Find
U.S.
biotech
sponsors
in
need
of
oncology
study
expansion.
Once
we
have
an
idea
of
what
is
needed,
we
ac(vely
aDend
key
oncology
events
like
AACR,
ASCO
and
ASH
in
an
effort
to
meet
with
sponsors
developing
in
the
key
indica(ons
Canadian
sites
are
in
need
of
for
their
pa(ents.
13. 2sTEP Sponsor
compounds/studies
matched
to
needs
of
Canadian
sites
Once
a
match
is
found,
we
offer
to
help
the
sponsor
enhance
their
recruitment
by
expanding
their
trial
to
the
right
sites
in
Canada.
14. 3sTEP Approach
select
sites
with
summary
of
criteria
We
execute
a
mutual
CDA
with
the
sponsor
and
request
that
they
allow
us
to
use
our
CDA
template
to
share
info
with
the
sites.
Having
been
around
since
1997
means
the
sites
know,
like
and
trust
us.
We
help
accelerate
the
process
with
the
help
of
pre-‐approved
templates.
15. 4sTEP
Introduce
sponsor
to
sites
and
discuss
viability
&
feasibility
Once
we
have
confirmed
interest
we
coordinate
a
conference
call
with
each
Inves(gator
so
the
sponsor
can
assess
the
sites’
level
of
engagement
for
themselves.
16. 5sTEP Iden(fy
best
fit
sites
We
typically
iden(fy
more
sites
than
are
required
so
the
sponsor
has
the
privilege
of
cherry-‐picking
the
best
sites
for
their
program.
17. 6sTEP Start-‐up
&
FPI
(first
pa(ent-‐in)
The
proof
is
in
the
start-‐up
and
the
Reverse
Feasibility
approach
has
resulted
in
start-‐up
(mes
that
are
rou(nely
up
to
50%
faster
than
the
industry
average.
20. REB
Strategy
sTart-up strategy
Unlike
centers
in
the
U.S.,
Canadian
ins(tu(ons
do
not
have
private
Central
Ethics
Boards.
Provincial
review
boards
propose
that
sites
iden(fy
a
“lead
site”
to
coordinate
with
all
other
par(cipa(ng
sites.
As
you
can
see
by
these
flowcharts
it’s
a
complex
process.
That’s
why
it’s
so
cri(cal
to
have
the
right
team
on
the
ground
to
help
you
navigate
the
system
and
expedite
start-‐up.
21. 21
Site
Contract
Strategy
sTart-up strategy
Scimega
model
Clinical
Trial
Agreement
Process
Our
model
CTA
is
US
biotech
friendly
(addressing
all
key
issues
such
as
IP,
indemnity,
ownership
and
obliga(ons),
and
it
has
been
nego(ated
and
approved
with
all
the
top
cancer
centers
in
Canada.
This
alleviates
the
administra(ve
burden
on
the
sites
and
removes
the
contract
signing
boDleneck,
thereby
expedi(ng
start-‐up
which
leads
to
faster
FSO
and
First
Pa(ent
In.
22. 22
sTart-up strategy
Regulatory
Strategy
• Parallel
REB
/
Health
Canada
Review
(Ame
to
prepare
a
CTA:
1-‐2
weeks)
• Having
the
right
contacts
at
Health
Canada
(official
/
unofficial
discussions)
• Knowing
when
to
hold
a
pre-‐CTA
meeAng
and
when
to
avoid
it
23. Average
Site
Start-‐Up
(me
in
Canada
36 weeks
Scimega
Site
Start-‐Up
(me
using
Reverse
Feasibility
14 weeks
»
»
Why
do
some
trials
take
forever
to
start-‐up
and
then
lag
behind
in
recruitment,
while
other
trials
just
seem
to
take
off?
We
found
that
what
truly
mo(vates
them
is
not
a
monetary
incen(ve,
but
rather
the
chance
to
par(cipate
in
cuing-‐edge
science,
that
has
academic
merit
and
publica(on
opportuni(es.
26. Phase
1
dose
finding
HER2+
BrCa
study
looking
at
oral
HER2
inhibitor
in
combina(on
with
T-‐DM1
Trial
had
been
ongoing
for
6
months
at
7
sites
in
the
U.S.
Target
end
of
recruitment
by
July
2015
cAse study 1
Situation:
27. challenge reason Action taken
Slow
Enrolment
0.1
pts/month
Scarcity
of
comparator
arm
naïve
subjects
(comparator
drug
in
wide
use
in
US)
3x
Repeat
customer:
Came
to
Canada
aMer
last
study
was
completed
3
months
ahead
of
schedule
cAse study 1
28. Introduced
Sponsor
to
select
Reverse
Feasibility
Champions
Confirmed
Inves(gator
Interest
(comparator
arm
approved
but
not
yet
covered
for
2nd
line)
results
Iden(fied
5
sites
in
less
than
two
weeks
Selected
4
sites
Average
Start-‐Up:
14
weeks
from
CPS
to
SI
Study
closed
to
enrolment
in
April
2015
1
2
3
cAse study 1 START-UP METRICS
4
30. Thanks
to
the
Reverse
Feasibility
Program
and
Scimega’s
ability
to
aCract
perEnent
clinical
trials
to
Canada,
several
of
my
paEents
were
able
to
LIVE
significantly
longer.”
Dr. Cristiano ferrario
Montreal Jewish General hospital
“2015 reverse feasibility champion”
31. cAse study 2
Situation:
Sophis(cated
Phase
III
Immuno-‐Oncology
study
in
mRCC
Global
trial
ongoing
for
14
months
Recruitment
at
risk
Minimize
logis(cal
complexity
32. challenge reason Action taken
cAse study 2
Slow
Enrolment
L o g i s ( c a l
C o m p l e x i t y
(required
fresh
tumor
sample
collec(on
and
access
to
leukapheresis
lab)
Site
Expansion
:
Were
told
by
exis(ng
CRO
that
Europe
was
the
op(on;
not
Canada
due
to
lack
of
PI
interest
&
sites
with
limited
capabili(es
33. Introduced
Sponsor
to
select
Reverse
Feasibility
Champions
Confirmed
Inves(gator
Interest
(comparator
arm
approved
but
not
yet
covered
for
2nd
line)
results
cAse study 2
Within
2
weeks
we
had
confirmed
6
sites
Sponsor
selected
top
5
sites
to
add
to
exisAng
four;
In
the
end
we
doubled
the
#
of
sites
in
Canada
Average
Start-‐Up:
9.3
weeks
from
CPS
to
SIV
1
2
3
4
START-UP METRICS
34. Introduced
Sponsor
to
select
Reverse
Feasibility
Champions
Confirmed
Inves(gator
Interest
(comparator
arm
approved
but
not
yet
covered
for
2nd
line)
results
cAse study 2
Scimega
ExisAng
CRO
in
Canada
IRB
TYPE
Local
Local
#
sites
5
4
Time
from
CPS
–
IRBapp
7.8
weeks
14.1
weeks
Time
from
IRBapp
–
SIV
1.5
weeks
total:
9.3
weeks
18.7
weeks
total
:
32.8
weeks
START-UP METRICS
36. Scimega
managed
to
expedite
EC/IRB
regulatory
submissions
at
the
site
level,
and
did
it
much
faster
than
our
global
CRO.
They
are
nimble,
aDen(ve
and
have
an
experienced
oncology
team
that
can
handle
all
aspects
of
study
opera(ons
and
site
level
needs”
VP, Clinical and medical affairs
37. Subscribe to
our blog
to
follow
the
progress
of
ongoing
clinical
trials.
hDp://www.scimega.com/blog
38. disclaimer
While
some
ini(al
resistance
from
the
exis(ng
CROs
is
to
be
expected
it
is
nice
to
see
how
fast
their
study
teams
mesh
with
ours
and
how
quickly
they
appreciate
that
our
success
means
the
trial’s
success,
which
ul(mately
translates
into
their
own
success.
NO
U.S.
CROs
WERE
HARMED
DURING
THE
CONDUCT
OF
THESE
TRIALS.
39. Mobilizing an expert canadian
team significantly enhances
study start-up & overall
performance
conclusion
41. PATIENT A.D.C
ALDO
DEL COL
Since
being
diagnosed
with
Mul(ple
Myeloma
in
2002,
Mr.
Del
Col
co-‐founded
Myeloma
Canada,
the
only
non-‐profit
organiza(on
uniquely
focused
on
the
needs
of
the
Canadian
myeloma
community.
Myeloma
Canada
works
with
regional
support
groups,
key
myeloma
experts
and
other
pa(ent
organiza(ons.
Their
Scien(fic
Advisory
Board
brings
together
Canada’s
leading
myeloma
inves(gators
and
clinicians
and
is
the
founda(on
of
the
Myeloma
Canada
Research
Network
(MCRN),
a
myeloma
study
group
that
ac(vated
its
first
clinical
trial
early
in
2012.