A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Tr...Target Health, Inc.
DIA 2019 presentation by Dr. Jules Mitchel with Michelle Eli (Lilly) and Tom Haag (ex-Novartis) based on their experience with Lilly collaborating on Target Health's paperless clinical trial system.
Process Analytical Technology, Quality by Design & PharmacogenomicsAjaz Hussain
Keynote address at the 2013 Scientific Conference of the Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas (NAPPSA). The lecture attempts to 'connect the dots' between PAT and QbD to Pharmacogenomics in the context of the authors experience at the US FDA and in industry.
If you had time for an open discussion with our MyRBQM® Academy instructors, what would you ask Johann, Jo, Linda, or Artem? In our monthly Ask the Expert webinars, we give you that chance. These webinars will focus on trending topics in the area of risk-based quality management (RBQM) - like remote and adaptive monitoring, centralized statistical monitoring, change management, predictive analytics... and more.
Besides a 20-minute Q&A session, our industry experts Jo Burmester and Dr Johann Proeve will dive into:
- How things might change while going forward post-COVID-19
- Statistical guidance for trials impacted by COVID-19
Learn more about MyRBQM Academy here: https://cyntegrity.com/myrbqm-academy/
A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Tr...Target Health, Inc.
DIA 2019 presentation by Dr. Jules Mitchel with Michelle Eli (Lilly) and Tom Haag (ex-Novartis) based on their experience with Lilly collaborating on Target Health's paperless clinical trial system.
Process Analytical Technology, Quality by Design & PharmacogenomicsAjaz Hussain
Keynote address at the 2013 Scientific Conference of the Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas (NAPPSA). The lecture attempts to 'connect the dots' between PAT and QbD to Pharmacogenomics in the context of the authors experience at the US FDA and in industry.
If you had time for an open discussion with our MyRBQM® Academy instructors, what would you ask Johann, Jo, Linda, or Artem? In our monthly Ask the Expert webinars, we give you that chance. These webinars will focus on trending topics in the area of risk-based quality management (RBQM) - like remote and adaptive monitoring, centralized statistical monitoring, change management, predictive analytics... and more.
Besides a 20-minute Q&A session, our industry experts Jo Burmester and Dr Johann Proeve will dive into:
- How things might change while going forward post-COVID-19
- Statistical guidance for trials impacted by COVID-19
Learn more about MyRBQM Academy here: https://cyntegrity.com/myrbqm-academy/
We are driven by a passionfor transforming products into brands and patients into survivors. Navicor is a 100% healthcare-focused, full-service agency that understands the unique aspects of the oncology marketplace. We have extensive oncology launch experience and have partnerships with large and small pharma and biotech companies.
Leverage Your EDC Solution to Mitigate Risk in Clinical Researchwww.datatrak.com
Every clinical trial is built upon a study protocol - the cornerstone of any trial. A well-defined and written study protocol provides the blueprint for the study, defining its purpose and goals. Studies have become more complex, creating more complicated study design, which can lead to making adherence more challenging for the study team and participants. The potential risk that some aspect of the study could be done incorrectly or not comply is inherent in all studies, but particularly present in complex research.
In order to help mitigate risk, advances in technology and the tools available today provide ways for us to mitigate some of the risk introduced in our clinical trials. While the study protocol is a cornerstone for the clinical trial, electronic data capture (EDC) applications have evolved in the broadest sense into technology solutions that provide us with a variety of tools to help mitigate risk.
These slides use concepts from my (Jeff Funk) course on Business Models at National University of Singapore to analyze the business model for Theranos. Theranos provides diagnostic testing for consumers that is faster and cheaper than the existing system. Its tests are done in easy to access pharmacies (e.g., Walgreens) as opposed to hard-to reach doctors’ offices. The tests use small bio-electronic integrated circuits (ICs) instead of large scientific instruments. These ICs utilize micro-fluidic channels that require a pin-prick of blood instead of a vial of blood, which makes the tests more appealing and faster than the traditional tests. The slides describe the value proposition, method of value capture, customers, scope of activities, and method of strategic control for Theranos.
Introduction to MedDRA Coding in Drug Safety & Pharmacovigilance Process for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
User Interface Design for Medical Devices - The Relationship Between Usabilit...UXPA Boston
User Interface Design for Medical Devices - The Relationship Between Usability and Safety
Rich Newman's presentation from the UXPA Boston 2016 conference
In the course of any clinical trial, there are risks associated with specific activities and tasks. This webinar will highlight some of these key risk areas and provide guidance on combining technology with best practices to help mitigate risks.
How To Optimize Your EDC Solution For Risk Based Monitoringwww.datatrak.com
This presentation presents best training practices to leverage EDC technology and risk-based monitoring to effectively and efficiently monitor clinical research.
Our focus is on the practical process of preparing your team to optimize the tools made available through an EDC solution.
This presentation is applicable to CRA’s, clinical project managers, clinical data managers, regulatory compliance professionals, and those involved in the design and implementation of risked-based monitoring plans.
It's all about critical thinking. To fully manage risk, risk-based organizations need to develop an approach that supports critical thinking. This slide deck is dedicated to the fundamental Critical Processes & Critical Data knowledge every risk-oriented clinical expert must have.
Clinical data management (CDM) is a covered part in the clinical trial and most commonly used tools for the purpose of effectivity of clinical research
From Edge Case to Main Case, Michelle Longmire of Medable_mHealth IsraelLevi Shapiro
Presentation by Michelle Longmire, CEO of Medable, April 20, 2021, for mHealth Israel. During CoVID, as physical access to clinics was limited, Medable enabled patients to continue participating in critical research efforts. Medable Supporting over 100 Studies Across a Diverse Array of Therapeutic Areas. Medable provides a platform for seamless evidence
generation, across the entire patient journey. Connecting patients globally for community, care, and research. Improve patient experience and retention. Reduce site burden. Data Cloud & Platform should be flexible and modular to enable protocol-fit digital. Medable Digitome, for data driven decentralized trials and a new era of understanding patients, therapies, and conditions. Clinical research is a small component of the broader healthcare journey. Enable health data and evidence generation from clinical to commercial, from day one. Continuous health data & evidence from clinical to commercial and beyond. The Digitome can provide a
primary observational protocol that collects large scale baseline data in a framework that enables streamlined recruitment, enrollment, and participation into interventional clinical substudies.
The Role of Technology in Streamlining Clinical Trial ProcessesClinosolIndia
Technology plays a significant role in streamlining clinical trial processes, enhancing efficiency, data quality, and participant engagement. Here are some key areas where technology contributes to the optimization of clinical trials
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
We are driven by a passionfor transforming products into brands and patients into survivors. Navicor is a 100% healthcare-focused, full-service agency that understands the unique aspects of the oncology marketplace. We have extensive oncology launch experience and have partnerships with large and small pharma and biotech companies.
Leverage Your EDC Solution to Mitigate Risk in Clinical Researchwww.datatrak.com
Every clinical trial is built upon a study protocol - the cornerstone of any trial. A well-defined and written study protocol provides the blueprint for the study, defining its purpose and goals. Studies have become more complex, creating more complicated study design, which can lead to making adherence more challenging for the study team and participants. The potential risk that some aspect of the study could be done incorrectly or not comply is inherent in all studies, but particularly present in complex research.
In order to help mitigate risk, advances in technology and the tools available today provide ways for us to mitigate some of the risk introduced in our clinical trials. While the study protocol is a cornerstone for the clinical trial, electronic data capture (EDC) applications have evolved in the broadest sense into technology solutions that provide us with a variety of tools to help mitigate risk.
These slides use concepts from my (Jeff Funk) course on Business Models at National University of Singapore to analyze the business model for Theranos. Theranos provides diagnostic testing for consumers that is faster and cheaper than the existing system. Its tests are done in easy to access pharmacies (e.g., Walgreens) as opposed to hard-to reach doctors’ offices. The tests use small bio-electronic integrated circuits (ICs) instead of large scientific instruments. These ICs utilize micro-fluidic channels that require a pin-prick of blood instead of a vial of blood, which makes the tests more appealing and faster than the traditional tests. The slides describe the value proposition, method of value capture, customers, scope of activities, and method of strategic control for Theranos.
Introduction to MedDRA Coding in Drug Safety & Pharmacovigilance Process for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
User Interface Design for Medical Devices - The Relationship Between Usabilit...UXPA Boston
User Interface Design for Medical Devices - The Relationship Between Usability and Safety
Rich Newman's presentation from the UXPA Boston 2016 conference
In the course of any clinical trial, there are risks associated with specific activities and tasks. This webinar will highlight some of these key risk areas and provide guidance on combining technology with best practices to help mitigate risks.
How To Optimize Your EDC Solution For Risk Based Monitoringwww.datatrak.com
This presentation presents best training practices to leverage EDC technology and risk-based monitoring to effectively and efficiently monitor clinical research.
Our focus is on the practical process of preparing your team to optimize the tools made available through an EDC solution.
This presentation is applicable to CRA’s, clinical project managers, clinical data managers, regulatory compliance professionals, and those involved in the design and implementation of risked-based monitoring plans.
It's all about critical thinking. To fully manage risk, risk-based organizations need to develop an approach that supports critical thinking. This slide deck is dedicated to the fundamental Critical Processes & Critical Data knowledge every risk-oriented clinical expert must have.
Clinical data management (CDM) is a covered part in the clinical trial and most commonly used tools for the purpose of effectivity of clinical research
From Edge Case to Main Case, Michelle Longmire of Medable_mHealth IsraelLevi Shapiro
Presentation by Michelle Longmire, CEO of Medable, April 20, 2021, for mHealth Israel. During CoVID, as physical access to clinics was limited, Medable enabled patients to continue participating in critical research efforts. Medable Supporting over 100 Studies Across a Diverse Array of Therapeutic Areas. Medable provides a platform for seamless evidence
generation, across the entire patient journey. Connecting patients globally for community, care, and research. Improve patient experience and retention. Reduce site burden. Data Cloud & Platform should be flexible and modular to enable protocol-fit digital. Medable Digitome, for data driven decentralized trials and a new era of understanding patients, therapies, and conditions. Clinical research is a small component of the broader healthcare journey. Enable health data and evidence generation from clinical to commercial, from day one. Continuous health data & evidence from clinical to commercial and beyond. The Digitome can provide a
primary observational protocol that collects large scale baseline data in a framework that enables streamlined recruitment, enrollment, and participation into interventional clinical substudies.
The Role of Technology in Streamlining Clinical Trial ProcessesClinosolIndia
Technology plays a significant role in streamlining clinical trial processes, enhancing efficiency, data quality, and participant engagement. Here are some key areas where technology contributes to the optimization of clinical trials
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
The Benefits of a Seamless IRT and EDC Integration in Clinical Trial ExecutionVeeva Systems
Watch the video here: https://bit.ly/3upehbN
Veeva and Suvoda have combined their offerings into a powerful streamlined integration, which accommodates advanced study designs while driving down build and casebook complexity.
Hear Catherine Munera, head of biometrics at Cara Therapeutics, share the benefits of moving from a single provider to taking a harmonized, best-of-breed approach with IRT and EDC.
EDC In Clinical Trials| Electronic Data Capture In Clinical Trialseclinicaltools
Unlock the transformative power of Electronic Data Capture (EDC) in clinical trials. EDC revolutionizes data management, ensuring real-time access, data accuracy, and streamlined processes. By replacing paper-based systems, it enhances efficiency, reduces errors, and expedites decision-making. Its adaptability facilitates various study designs, from traditional to decentralized trials. With features like remote monitoring and ePRO integration, EDC promotes patient-centricity. Embrace the future of clinical research, where EDC not only meets but exceeds the demands for precision, speed, and compliance, ultimately paving the way for more successful and patient-friendly trials.
Bridging Health Care and Clinical Trial Data through TechnologySaama
Karim Damji, SVP of Product and Marketing, presented at the Bridging Clinical Research and Clinical Health Care conference held at the Gaylord in National Harbor on April 4-5, 2018.
Clinical Data management is one of the vital part of clinical research.
Clinical research is research on drugs,devices ,medicines that has to be adminstered for various diseases and illness,to check the efficacy and safety in human voluteers or patients.
It helps in determining dose and dosages of a particular drug or treatment regimen.CR also helps in label expansion of investigational drug. Furthermore it helps in checking any adverse event in post marketed drug which increases the potability of drug among population of various geographical regions.There are various guidelines and regulatory bodies from several parts of world . Each country has its own regulatory body both at state and central level,eg.CDSCO for India,TGA for Australia,USFDA for USA,MCC for South Africa ,UNCST for Uganda,EMEA for European Union,MHRA for UK.Thus CDM plays important role in maintaining accuracy,consistencies,validity reliabilty of available data.It also in decreasing redundancy of duplicate and inconsistent data.It is required to resolve issues pertaining to inaccuracy , signal detection in pharmacovigilance. CDM is completed in three steps set up,conduct ,close out.Database used i n cdm are DBMS ,MS -Access,OC-RDC.Data managers,operators,programmers,developers are include in the process.CDMS Clinical data management system ,clinical system validation.
Successful Selection and Implementation of EDC (Electronic Data Capture) System Eleazar Noel
1. Selecting Electronic Data Capture Tools
2. Determining the EDC Budget
3. Usability and flexibility of the system
4. Implementation of EDC System in Clinical Trials
Find out the best practices for implementing Electronic Data Capture systems in clinical trials http://bit.ly/2beFVmV
"Electra HIS" is developed & promoted by ACG Infotech Limited, a NASSCOM Company under the guidance of professional medical doctors. Electra HIS, is fully integrated and possesses the ability to share and exchange information across the platforms in real time and make the hospital paperless. Electra HIS is multi-location application complied with following Standards.
Leverage Big Data Analytics to Enhance Clinical Trials from Planning to Execu...Saama
Nikhil Gopinath, Senior Solutions Engineer for the Life Sciences at Saama, spoke at EyeforPharma's Clinical Trial Innovation Summit event in February 2017. These slides are from his "Leverage Big Data Analytics to Enhance Clinical Trials from Planning to Execution" presentation.
Network, Technology, and Data: Missing Pieces of the Puzzle for Clinical Tria...Health Catalyst
There is a massive shortfall in the enrollment and accrual of patients for clinical trials. Identifying the “right patients for the right trials at the right time” is a growing concern for providers, pharmaceutical companies, and clinical research organizations. In this webinar, we will discuss the evolution of clinical trials, including how to break barriers to enable successful clinical research as a care option, how clinical research impacts patient satisfaction and revenue, and more.
The clinical development data deluge is reaching critical mass for pharmaceuticals. Use of varied data for targeted outcomes remains difficult, despite studies that generate evidence of the risk-benefit profile of investigational products. New technologies are federating the ability to leverage analytic-ready data for innovations in clinical operations and clinical science. With the application of clinical data-as-a-service and meta-data core, centralized clinical data lakes have the power to improve data quality, evidence generation, and time-to-insights.
Karim Damji and Benzi Mathews presented this deck at the Clinical Trial Innovation Summit held in Boston on April 24-26.
The Risk-Based Monitoring (RBM) discussion is moving away from one focused on changing monitoring methods and reducing source document verification (SDV) to 'intelligent monitoring.' Learn why here!
Real world clinical medical data. Corporate presentation of Ad Scientiam which is a startup specialized in real life data acquisition during clinical trials.
Learn more at : www.adscientiam.com
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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).
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
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The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Light House Retreats: Plant Medicine Retreat Europe
Navigating the Complexity of Virtual Clinical Trials
1. NAVIGATING THE
COMPLEXITY OF
ADOPTING VIRTUAL
CLINICAL
TRIALS
Emily Kunka
Digital Business Transformation Lead, UCB
Michelle Luo
Head of Global Evidence and Outcomes,
Gastroenterology, Data Science Institute,
Takeda
2. The views we share here are ours, based upon our
own experience in several business settings and do
not represent the views of our current employers.
We are admittedly biased and passionate about this
burgeoning field.
DISCLAIMER
3. OBJECTIVES
● Understand the complexity of building virtual trial
capabilities
● Recognize and adapt to the challenge of
navigating multiple stakeholders
● Evaluate vendor capabilities for partnering in
DCTs
5. SPECTRUM OF COMPLEXITY
Electronic Patient
Reported Outcome
[ePRO] Questionnaires
and eDiaries
Electronic
Consent
(eConsent)
Smart Mobile
Devices Used
by Mobile
Nurses
Performance
Outcomes [PerfOs]
(ie. 6MWT)
REMOTE ASSESSMENTS
ClinROs by
Investigator over
Telemedicine or
with Mobile Nurse
as rater
Patients’ Passive
Use of Smart
Devices
(ie. Wearables)
In-home sample
collection and
pre-processing
IN-HOME ASSESSMENTS
Patient Active
Use of Devices
with Active Tasks
Sample
Collection
at Local
Labs
6. PATIENT EXPERIENCE DESIGN
WHAT
WHO
Is present during the study
visits (SC, MRN, PI)?
Is appropriate to do within
the home? In what order?
What can be shipped direct-
to-patient?
WHERE
Should assessment take
place within the home (ie.
bed, hallway, near
window)?
HOW
Are assessments completed
within the home (ie.
methodology and equipment
needed)?
7. KEY
CONSIDERATIONS
03
01
02
04
ASSESSMENTS
What assessments have
been done remotely before?
Have they been validated?
VENDORS
What services do
vendors (ie. mobile
nursing, platform,
device) have to offer?
DEVICES
What is commercially
available? 510k cleared?
Available for researchers?
How do they work,
integrate with the selected
platform?
LABS
Sample processing
requirements
(Incubation,
refrigerated
centrifugation) Sample
9. STAKEHOLDER MAPPING
√√INTERNAL
● Executive Leadership
● Clinical Development Team
○ Clinical Science
○ Regulatory
○ Clinical Operations
○ Data Analysis/Stats
● Digital
Transformation/Device/IT
● Real World Data/Outcomes
Research
● Patient Engagement
● Legal
● Procurement
EXTERNAL
● CRO
● Brick and Mortar Sites
Investigators and Staff
● Patients/Caregivers
● Regulatory Agencies
● Vendors
○ Virtual trial site vendors
○ Telemedicine vendors
○ Central and Local Labs
○ Mobile nursing/home
health vendors
○ ePRO vendors
10. INVESTMENT
● Up front costs for infrastructure
● Time required for new trial designs
● Uncertainty for regulatory pathway
DATA
● Perceived lack of scientific rigor
● Data linkages, privacy, and rights
● Security and data residency (ie. GDPR)
● Data volume and analysis
TECHNOLOGY
● Limited usability/reliability testing
● Access to new technology/devices
● User training for new technologies
STAKEHOLDER CHALLENGES
14. STATUS QUO
Traditional CRO Specialized Vendors
Investigator Selection eCOA (ie. ERT, Kayentis)
Site Training eConsent (ie. ClinConsent)
Study Monitoring eSource (ie. Clinical Ink)
Participant Compensation EDC (ie. Medidata)
Recruitment Strategy IRT (ie. Endpoint)
Data Management Home Health (ie. MRN)
Vendor Management Telemedicine (ie. AmWell)
Device Management Direct-to-Patient Shipments
Medical Writing Drug Supply (ie. Marken)
15. EMERGING DCT VENDORS
Investigator Selection eCOA
Site Training eConsent
Study Monitoring eSource
Participant Compensation EDC
Recruitment Strategy IRT
Data Management Home Health
Vendor Management Telemedicine
Device Management Direct-to-Patient
Shipments
Medical Writing Drug Supply
16. FLUID ROLES & RESPONSIBILITIES
CRO
VENDORS
VIRTUAL
TRIAL
PLATFORM +
SERVICE
COMPANIES
SITE
26. CREDITS: This presentation template was created by
Slidesgo, including icons by Flaticon, and infographics &
images by Freepik.
THANKS!
Copyright Emily Kunka and Michelle Luo 2020.
All rights reserved
Editor's Notes
EMILY: Hello and welcome to Navigating the complexity of adopting virtual clinical trials my name is Emily Kunka and I have the privilege of working for UCB in Digital Business Transformation. I’ve had the pleasure of partnering with and getting to know Michelle Luo over the last several months who is Head of Global Evidence and Outcomes at Takeda where she also currently leads a virtual clinical trial think tank.
Both of us have complementary experience in the area of virtual clinical trials, but from differing perspectives-- myself mainly from designing and operationalizing virtual trials and Michelle from a change management and implementation perspective. I believe that we can tackle and explore challenging areas more deeply if we gain a more holistic perspective and that is what we hope to offer here today.
Before we get started I wanted to take a minute to give a bit of a disclaimer that the views we share here today are ours, based upon our own experience in several business settings and do not represent the views of our current employers. We are admittedly biased and passionate about this burgeoning field.
I have to be honest with you all that the early days of this work, pre-COVID, was arduous largely due to the fact that telemedicine was not widely in practice, so if there is any silver lining to this pandemic it’s that this work is not only fun and exciting and challenging but NECESSARY as we evolve into imagining what a post COVID world looks like. So if there’s anything you take away from the conversation today it’s my hope that it’s greater optimism that some of the obstacles we initially faced in a pre-COVID world have been tempered, if not removed, over the last 8 months as more and more research professionals see the value of advancing this approach.
EMILY: Michelle and I plan to cover the following three objectives today...
EMILY: Starting with the first objective...
EMILY: I’d like to start by candidly saying that when I saw the title of this conference I wondered about the use of the word “virtual”. The importance of terminology cannot be understated and for many years the neural pathways in my brain have been trained to use the acronym DCT meaning decentralized clinical trials, and for good reason, which I hope this slide will illustrate.
Decentralized trials come in a variety of flavors, and there is a spectrum of implementing components of remote and in home assessments which are of varying difficulty. On the left hand side you’ll see items we’ve been doing for years like eConsent and ePROs which are “less controversial”, more “passive”, and straightforward if you will. But as you move towards the right hand side, things start to get a bit less standardized and more “active” with a greater need for planning, coordinating, and training. Assessments get gradually more complex for all people involved (both the study team and the patient) as you move from left to right.
When I think of the phrase “virtual clinical trial”, I think of a trial at the far right end of this spectrum, but in reality, very few studies are entirely virtual these days. Most people are still navigating their way through hybrid trials, at best, seeing how they can move the needle from the left side of the screen to the right. It is not an easy process-- and one’s ability to move from left to right is iterative in nature and largely depends on a whole host of factors.
So to step off of my soap box, I personally prefer the term DCT and think that that is a more accurate term which reflects where we are as an industry. This approach is still in its infancy and collectively we’re all charting the course for how to do this. It’s certainly not a one size fits all approach.
EMILY: So one of the most exciting parts about the shift that is happening to DCTs is the fact that it allows us to mesh the best of several worlds-- medical science, technology, and design.
We are finally waking up to the fact that if patients are our end users than we need their feedback and insights earlier in the development process, and their feedback MATTERS. Not only are we looking at more endpoints that matter to patients but we are also charged with creating trial experiences which better respond to patient’s needs.
So to that end, when thinking about designing DCTs we need to consider patient experience design if we’re going to do things right. [read slide]
EMILY: There are a lot of “behind the scenes” decisions that need to be made in order to optimize workflow, patient experience, communication, and increase the likelihood of trial success. So as we go to apply a DCT model to clinical study design there are many considerations needed, but I’ve outlined 4 key areas here.
1- [read slide] Are there new assessments to pilot for exploratory endpoints which may be better than the gold standard?
2- [read slide] We’ll get into this more in the latter part of this presentation
3- [read slide] Where is the device being deployed? Do they require a CE mark? If there is not a CE mark, what is the documentation required to satisfy ethics committees or import requirements for customs clearance?
4- [read slide] We need to think about sample turnaround time and viability. I’ve heard stories of mobile nurses centrifuging samples in their car -- so we need to clear define what practices are appropriate. How do we create and remove a “clinical space” within the patient’s home without all of the equipment we’re accustomed to having? Can we use a wet ice bath instead of refrigerated centrifugation? Can we minimize the amount of workarounds that are required? The phrase “thinking outside the box” is often trite, but it is so applicable and needed here. Oftentimes we have to get creative.
With that I’ll turn the floor over to Michelle to speak about navigating what I call the “stakeholder forest” once you have a solid protocol design and operational plan for a DCT study in place. Michelle...
MICHELLE: thanks Emily for giving an overview of the complexity of decentralized trial design, I am going to continue to share with you about recognizing and adapting multiple stakeholders. Although over the last few months, we have seen more and more clinics started to offer telemedicine or remote care, the overall adoption of virtual trials has been slow across the pharmaceutical industry. Why, because this is an uncharted territory, and many decision makers need to be brought on board.
MICHELLE: From an internal perspective of an pharmaceutical company, you will have typical players centered around clinical development teams to start look into a new design of virtual trials typically hybrid trials, but some new players also need to be at the table, including digital transformation, device and IT, in order to evaluate opportunities and feasibilities for collecting digital biomakers and remote data collection. Externally, we can’t rely on only the CRO partners to work with brick and mortar study sites, we need to evalaute and engage new set of partners , such as telemedicine vendors, virtual trial site vendors, and mobile nursing and home health vendors, which will provide decentralized services and offer more flexibility for patients and caregivers to participate trials at their home or places convenient to them.
MICHELLE: Clinical trials have been conducted for over 200 years (first one in 1747 by James Lind), with the sudden disruption by COVID pandemic, the industry has been forced to make changes to keep drug development on track. There are a lot of challenges, some are real some might be perceived. In general, there are 3 categories of challenges, investment, data and technology. I would like to highlight for you the data challenges, (Read slide)
MICHELLE: We have realized that we need to Think Different, and implement change management.
Demystify virtual trials: this starts with education, both internally and externally. Internally, we need people to understand the risk/benefit ratio. Externally, we need to cultivate a scientific community with early adopters which will champion and pave the way for others to come.
Set organization priorities: Up front investment for infrastructure, build time required for new trial designs, engage early with regulatory agencies for new regulatory pathways
Engage right partners: We must support the efforts that lead to the development of new technologies, devices, and measurements as part of modern patient care. We can’t sit back and wait for this to happen on its own. We need to create a sense of urgency.
MICHELLE: Where do we start? We need to start now with front loading investments, so that we can realize the ultimate goal of reducing trial burden on patients. All the while, simultaneously optimizing trial outcomes.
We can start small with piloting on one or two trials to form the core driving force within the company, building use cases that can share as best practices as well as lessons learned. However, to scale this, we need to build process maps and playbooks that we can later on use to train and socialize with others at the enterprise level.
EMILY: When we are scaling, we are not doing this alone. It is important to really evaluate and select the right vendor and take the journey together.
EMILY: The tired, old story of traditional pharma working with the traditional CROs and specialized vendors is changing. I’ve provided examples of these “specialized vendor” companies here, and there are many today that you might have heard of. And I’m sure there will be more to come!
These companies typically do one thing and do it well, which has also served us well up until this point, but segmented services and can lead to a disjointed approach to implementing a DCT model.
We are seeing that the gaps are being filled with emerging vendors who saw opportunity in this segmentation and have been very successful in doing so...
EMILY: In the spirit of offering a more integrated and comprehensive solution to DCTs, emerging DCT vendors are starting to appear. You’ll note that the items in pink here are the same items from the previous slide that traditional CROs and specialized vendors continue to offer that these new emerging DCT vendors are now offering together. Only a few services, noted in here white, remain as territory left to be commandeered.
They offer a suite of services which combine the capabilities of the specialized vendors which allows for greater customization of trial services with a technology backbone.
I’ll say it here and I think Michelle will say it again later, but we need to match the study design to the services that the emerging DCT vendor companies are offering and it’s becoming more and more possible to do so now that these lists of services are constantly growing and expanding.
EMILY: Because these emerging DCT vendors are taking on so many more responsibilities that were traditionally held by others (site/CROs/specialized vendors) no one quite knows how to define them and they can be a bit of a chameleon. From my experience, they tend to be more agile and diversify themselves quite well to be more marketable to whomever they’re working with. They can also be different things to different people depending on the needs of the trial and trial sponsor.
So their identity-- who they are and what they do--- on a project level has ended up being very dependent on the circumstances they’re in to allow for greater customization. While in a completely virtual study they may be a site, in hybrid study they may play the role of more of a vendor or CRO. It all just depends-- so when selecting partners you need to fully understand their services and we cannot put them in a proverbial box.
MICHELLE: We need to match the partner and services they offer to the study design itself. Phase IV trials may be more reliant upon DCT companies that have a solid platform with bring your own device (or BYOD) and global capabilities who are stronger on the tech side. In a phase II or III the focus may be more on the comprehensive suite of clinical offerings/disease/patient experience, especially looking at vendors that are willing to co-develop more patient-friendly Clinical Outcome Assessments that can be performed within the home.
We also need to consider what kind of trials the vendor has done before-- what is their geographic presence? How quickly can they mobilize local resources? What is their reputation? Have they been easy to work with? Have they been successful? Is there a potential for the partnership to grow and scale (especially when considering a phase II trial if there is a potential for a future phase III).
I cannot overstate the importance of making the right decision in partnership selection and it’s critical to align key stakeholders on that decision. So what you see here are some areas that may tip the scale in one direction or another when evaluating a potential partner. Some bubbles might be more relevant than others, depending on your use case. The right criteria for selection should be established early on and should be fit-for-purpose.
MICHELLE: To wrap up, today we talked about navigating the complexity of adopting virtual clinical trials. We’d like to transition to a time of discussion between Emily and myself to keep things a bit more interesting and fun. So we’ve selected some thought-provoking questions which we hope will pique your interest and get the wheels turning a bit more for you.
MICHELLE: [asks question]
EMILY: I believe certain therapeutic areas are a better fit than others simply due to the type and frequency of assessments they require. Dermatology is squarely one of those TAs-- it is simply easier to visualize the skin over telemedicine moreso than say oncology.
Also, study phase is very important. Phase II trials by being smaller, for example, are easier to work with than large phase IIIs. I have yet to see a phase I DCT-- if anyone knows of one that exists please let me know, but I have largely seen that there is no opportunity for DCTs in phase Is due to the more intense focus on long hospital stays for PK sampling.
My answer to the low hanging fruit question is phase IV trials as they tend to be lower touch and more direct-to-patient. There’s a greater opportunity for more real time/real world data collection which uses the existing tools that patients already have at their fingertips-- their smartphone/smart watch/ and in-home virtual assistants like Amazon Alexa. There is less “manpower” and resourcing oftentimes required for these types of trials as data collection and quality standards are less rigorous with “free-living” patients.
Lastly, I’d say that IP administration route has also bubbled up to be an important determinant for DCT viability. Oral or injectable drug studies are easier to implement than infusion studies for obvious reasons. Infusion studies oftentimes require a crash cart nearby for infusion reaction and that is just not practical within a patient’s home.
EMILY: [asks question]
MICHELLE: feedback should be timely and given right after the visit in an anonymized way, should also collect patient feedback on the protocol prior to studies in a patient roundtable with advocacy group involvement in parallel to tease out insights. Feedback could also be gleaned from the study team and mobile nurses throughout the study (not just at the end).
Need to understand patients needs. If have elderly patients, may prefer to go into the clinic. Patients who are parents and have kids may prefer the home health.
MICHELLE: [asks question]
EMILY:. Over the years we have seen more and more players on the scene, with an expanding number of options to choose from. As we alluded to earlier, we are seeing new tech vendors now in competition with traditional CROs and it can be a bit of a crowded space. But that competition is good-- it is driving folks to re-define value for both businesses and patients alike.
EMILY: [asks question]
MICHELLE: Yes, get them greater exposure, practice opportunities to have immersion in/experience what participation might look like as a patient. Simulation activities can be helpful for people within these companies to see what it would be like to be a patient or a user of the platform.
US FDA commitment/open to DCTs, issuing guidance to keep drug development going during COVID, active exploration and collaboration for adopting, “open science” “pre-competive sharing”
EU EMA Catching up from a policy perspective, no concrete guidelines, country by country approach is necessary as there are inconsistencies in adoption of home health and physician supervision of telemedicine assessments, need to encourage a more open environment for policy development, data privacy (GDPR) and cybersecurity are hot topics.
MICHELLE: [asks question]
EMILY: As we move into a post-COVID era, more companies are adopting these technologies and we can feel the environment shifting. The fact of the matter is, whether people like it or not, these changes we’ve had to implement in healthcare as a result of COVID are here to stay.
I love analogies, so I think of it this way-- the genie is out of the bottle at this point and it cannot be put back inside. There was sort of an inflection point when COVID started which propelled us at top speed to adopt telemedicine almost overnight. I truly believe we have the momentum at this point to move beyond purely digitalizing existing processes and ways of working and rather transforming how we think and act.
For years we discounted the average patient as disengaged, when in fact, we never gave them the opportunity to be engaged to begin with. So we’re seeing this mind-meld now where sponsors are directly connecting with patients and intermediaries of information are dwindling away as the voice of the patient is getting louder and clearer.
And these are all good things-- we are breaking down barriers and better listening to patients to find solutions that work for everyone involved. With investment comes insight and insight is valuable. I’m speaking about newly created, unique value which allows companies to better understand, and thus better tackle, the problems facing the patients they serve.
EMILY: [asks question]
MICHELLE: Bigger companies have resources up front to build the infrastructure and bring in a lot of players and layers to engage. On other hand small/mid-sized companies can be very focused and they can build partnerships and move quicker with emerging tech companies and have the mentality to be more agile for trying new things and taking more risks. Smaller companies can explore cost-sharing and are more likely to explore new use cases.
MICHELLE: [asks question]
EMILY: A critical mass is needed to drive this era of virtual forward. We need to create an ecosystem of shared resources, experiences, and learnings like we are doing today. We also need to pay attention to medical futurists and science fiction -- historically cartoons like the Jetsons and movies like Star Trek have jogged the imagination. I’ll share that Bertalan Meskó is my favorite medical futurist. Needless to say, we need to tinker, try, and sometimes even fail. And as cheesy as it sounds, we need to see failure as an opportunity to learn and improve. I wanted to leave you all with a quote from the spanish poet Jose Bergamin who wrote, “To be ready to fail, is to be prepared for success.” I think that perfectly sums up our mandate moving forward.
MICHELLE: Future starts now. We cannot wait or plan perfectly. Need action now. Learn from doing.
With that we have about XX time for questions from the audience. OR It looks like we’re out of time.
We’ve enjoyed being with you and thank you for your time.