Quality Archives - Page 17 of 27

Webinar Recording Available: Listen to Best Practices on Conducting Clinical Trials during COVID-19

Posted on March 31, 2020March 5, 2025 by Hannah Faulkner

During March 23-27, CTTI collected experiences from stakeholders across the clinical trials ecosystem – including insights on safety considerations, remote study visits, remote consent, consulting with IRBs, and more – related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. A recording of the March 31 webinar discussing those findings and best practices is now available.

Pam Tenaerts, CTTI, and M. Khair ElZarrad, FDA, CDER, opened the webinar by welcoming attendees and recognizing the importance of multi-stakeholder input and collaboration to move us forward during this crisis.

Sara Calvert, CTTI, then gave an overview on findings from CTTI’s recent effort to collect experiences and insights from across the clinical trials ecosystem, including best practices gleaned from participants around:

Keeping participants informed
Performing ongoing risk assessment
Pausing (most) new study starts and enrollment
Pivoting to remote study visits
Switching to remote monitoring
Documenting with COVID-19 tag
Communicating with IRBs

Colleen Rouse, Cleveland Clinic; David Borasky, WCG; and Cindy Geoghegan, individual patient representative/caregiver; provided unique perspectives and concrete examples related to these best practices. Among the many insights, the presenters unanimously underscored that “ensuring the safety of trial participants is paramount” and communicating with patients is critical.

View a full slide deck from the webinar to read more from each presenter.

To stay up to date on all of CTTI’s work around COVID-19, including this effort and future ones, please sign up to receive our e-newsletter and follow us on LinkedIn and Twitter.

Webinar on Best Practices on Conducting Clinical Trials during COVID-19

Posted on March 27, 2020March 5, 2025 by Hannah Faulkner

This week, stakeholders from across the clinical trials ecosystem submitted experiences and insights related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. The Clinical Trials Transformation Initiative (CTTI) collated the feedback – including insights safety considerations, remote study visits, remote consent, consulting with IRBs, and more – and will share the findings and best practices via a webinar on Tuesday, March 31 at 11:15 a.m. ET.

M. Khair ElZarrad, FDA, CDER, will provide opening comments and a full discussion on the findings, along with detailed examples of best practices, will be presented by:

David Borasky, WCG
Sara Calvert, CTTI
Cindy Geoghegan, Individual Patient Representative/Caregiver
Colleen Rouse, Cleveland Clinic
Pamela Tenaerts, CTTI

By exchanging best practices and insights, we can continue our important work to develop needed medical products during this situation, and perhaps even glean some opportunities to do clinical trials better, now and in the future.

Webinar Now Available: Findings & Reflections from CTTI’s ICH E6 Renovation Work

Posted on March 26, 2020March 5, 2025 by Hannah Faulkner

A recording is now available of a CTTI webinar on new stakeholder-informed research to identify areas within ICH E6 GCP that are in the greatest need of renovation. The webinar, held Thurs., March 19, included several perspectives about how this research could further the international conversation about ICH E6 GCP:

Celia Witten (FDA, CBER)
Amy Corneli (CTTI)
Dagmar Gortz (Janssen)
Pamela Gonzalez (University of Chicago)

Witten provided an overview of the ICH revision processes and expected timelines as well as the guiding principles behind the effort. She said that the knowledge gained by learning from stakeholder experience and viewpoints will further enrich ongoing expert working group discussions. “It’s quite valuable to us and lights the way to highlight certain areas that need more attention,” said Witten.

Corneli provided an overview of the research methodology and findings. She highlighted the three modes of the project: an online survey; qualitative, in-depth telephone interviews; and an open-comment platform. The research included the perspectives of more than 300 research professionals in 20 different global regions.

One of the key themes that stakeholders identified was that researchers need flexibility depending on the type of research being conducted and simplification of guidelines so that more investigators adhere to them. Transparency in the transition process and ensuring that a variety of stakeholders guide the process were also identified as priorities.

Gonzalez provided her thoughts on the research from the academic clinical site perspective. “The themes and the results of the survey are aligned with my own thoughts. There is a need for more flexibility. We need to have better alignment with the risk in protocols,” she said.

Gortz spoke through the lens of her industry role. She emphasized the need for case examples that could help illustrate how to use guidelines. “I was pleased to see the strong desire and strong ask for stakeholder engagement in the revision process for the guidelines,” she said.

Explore this research further by reading our executive summary, interview findings, survey findings, and open comment findings.

Webinar to Provide Findings & Reflections from CTTI’s ICH E6 Renovation Work

Posted on March 4, 2020March 5, 2025 by Hannah Faulkner

As the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) begins revisions to ICH E6 GCP, new CTTI research highlights opportunities for changes and improvements.

CTTI will host a webinar Thurs., March 19, at noon ET providing an overview of new multi-method research to identify areas within ICH E6 GCP that are in the greatest need of renovation. Speakers will include:

Fergus Sweeney (EMA)
Celia Witten (FDA, CBER)
Amy Corneli (CTTI)
Dagmar Gortz (Janssen)
Pamela Gonzalez (University of Chicago)

CTTI’s research includes the perspectives of more than 350 research professionals in 20 different global regions and describes stakeholder experiences with implementing ICH E6 GCP. Preliminary findings were presented to the FDA and EMA in advance of the first ICH E6 work group meeting in November 2019. Some of the initial findings include:

32.4 percent of respondents use mobile applications for the remote capture of efficacy or safety outcomes data for regulatory decision making
62.1 percent use routine health care data for capture of efficacy or safety outcomes data for regulatory decision making
60-75 percent of survey respondents indicated that renovation is not needed to the general principles
Areas identified as needing the most renovation included: Sponsor, Essential Documents, and Investigator. Of less need for renovation were topics in the section on Clinical Trial Protocol and Protocol Amendments.

To hear more, mark your calendar for the upcoming webinar today!

Quality By Design

Topics Included: Ensuring Quality

QbD Toolkit: Overview, Learn About QbD , Teach Others About QbD, QbD Principles Document, Exploring the CTQ Factors, Workshop Tools, Adopt QbD , How Others are Using QbD, Get Started

QbD Toolkit Resources: Principles Document, CTTI QbD Recommendations, Key Stakeholders, Maturity Model, Metrics Framework, Case Studies

SHARE TO:

Applying Quality by Design (QbD) in clinical trials offers numerous benefits, including avoiding errors, collecting data that is fit-for-purpose, and reducing patient burden. QbD focuses resources on the errors that matter most to decision-making during a trial.

CTTI has developed a comprehensive suite of resources to help implement QbD principles in clinical trials. These resources include recommendations for monitoring, QbD recommendations, a principles document, and a QbD toolkit. Recently, CTTI has added more tools to support effective QbD implementation, such as a metrics framework, maturity model, implementation guide, and documentation tool.

Discover how other organizations have successfully used CTTI's QbD recommendations to design and conduct better clinical trials.

What is the issue?

Collaborative partners and participants in the clinical trials ecosystem are concerned that the current model for conducting trials is unaffordable, unsustainable, and may hinder the generation of reliable evidence. To address this inefficiency, improvements in protocol design, trial planning, and quality oversight are essential.

CTTI identified the need to apply Quality by Design (QbD) methods to clinical trials while working on improving monitoring procedures. The CTTI Monitoring Project concluded that clinical trial monitoring should be part of an overall quality framework. Participants from various sectors of the clinical trials ecosystem agreed that adopting the QbD approach for trial planning, conduct, and oversight is crucial for ensuring trial quality and efficiency. However, there was limited information available on how to apply QbD principles to clinical trial design.

What CTTI projects have been initiated to address the issue?

What are the objectives of CTTI's work on QbD?

What is the anticipated impact of CTTI's work on QbD?

Utilizing the QbD toolkit from the beginning of a trial will help minimize significant errors, enhance the trial's overall integrity, and increase participant safety and the credibility of the results.
Concentrating on critical aspects of a trial, such as the critical-to-quality factors (CQFs) outlined in the Principles Document, will improve trial efficiency and significantly reduce the burden on sponsors by alleviating the perceived need to address every potential risk.

How was evidence gathered to support our findings?

Literature review
Electronic survey
Expert meetings and workshops
- Workshop on Quality Risk Management, January 29-30, 2014
- Workshop on Quality Risk Management, January 28-29, 2013
- Workshop on Quality Risk Management, September 20-21, 2012
- Workshop on Quality Risk Management, August 23-24, 2011
- Expert Meeting on Monitoring, October 13-14, 2010
- Expert Meeting on Monitoring, November 4, 2009
Qualitative interviews
Review of FDA warning letters

What were the findings from this project?

CTTI's investigation into monitoring practices across sponsor companies revealed significant variability, with choices often not based on empirical evidence. Experts agreed that the main objectives of monitoring practices are to ensure patient safety, accurately represent key data, comply with the protocol, and improve trial quality. Monitoring is most effective when it can identify errors early, allowing for corrective training to address issues, and should be tailored to the specific needs of a trial. Risk-based monitoring was suggested as a more effective alternative.

During the investigation and analysis of monitoring practices, it became clear that additional factors contribute to trial quality and efficiency. An expert working group recommended convening a follow-on Quality by Design (QbD) Project. QbD aims to build quality into the scientific and operational design of clinical trials from the outset, preventing important errors rather than remediating them after the fact, and ensuring trials are feasible to conduct. Through evidence-gathering activities, CTTI identified critical-to-quality (CTQ) factors in its Principles Document, including:

Protocol design
Feasibility
Patient safety
Study conduct
Study reporting
Third-party engagement

In addition to these factors, the project recommended practices that contribute to the successful application of QbD principles in clinical trials, such as:

Creating a culture that values and rewards critical thinking and open dialogue about quality, beyond just relying on tools and checklists
Focusing efforts on activities essential to the credibility of study outcomes
Involving a broad range of those with vested interest in protocol development and discussions around study quality
Prospectively identifying and periodically reviewing the critical-to-quality factors

CTTI provided examples of successful application of these principles in the QbD Webinar Series and offered guidance on implementing QbD in clinical trials through the QbD Toolkit.

Additional Resources

Project Team Members

Role	Name	Affiliation	Project
Project Manager	Annemarie Forrest	Clinical Trials Transformation Initiative	QbD
Project Assistant	Diane Willis	Clinical Trials Transformation Initiative	QbD
Team Leader	Mark Behm	AstraZeneca Pharmaceuticals LP	QbD
Team Leader	Martin Landray	University of Oxford, CTSU	QbD
Team Leader	Briggs Morrison	Development Syndax	QbD
Team Leader	Jean Mulinde	Food and Drug Administration	QbD
Team Leader	Stephanie Shapley	Food and Drug Administration	QbD
Team Member	John Alexander	Duke University	QbD
Team Member	Patrick Archdeacon	Food and Drug Adminstration	QbD
Team Member	Tim Baldwin	National Institutes of Health	QbD
Team Member	Leslie Ball	Food and Drug Administration	QbD
Team Member	David Breiter	Covidien Vascular Therapies	QbD
Team Member	Oana Brosteanu	Universitaet Leipzig	QbD
Team Member	Robert Campbell	Children’s Hospital of Philadelphia	QbD
Team Member	Lynda Chick	Bristol-Myers Squibb	QbD
Team Member	Theodora Cohen	Harvard Clinical Research Institute	QbD
Team Member	Sabrina Comic-Savic	Novartis	QbD
Team Member	Jason Connor	Berry Consultants	QbD
Team Member	Xiangchen (Bob) Cui	Vertex Pharmaceuticals	QbD
Team Member	Dan Delaney	CR Bard, Inc	QbD
Team Member	Jaques Demotes	ECRIN	QbD
Team Member	Dianne Dorman	National Organization for Rare Diseases	QbD
Team Member	John Farley	Food and Drug Administration	QbD
Team Member	Angeles Alonso Garcia	European Medicines Agency	QbD
Team Member	Cheryl Grandinetti	Food and Drug Administration	QbD
Team Member	Cyrus Guidry	Johnson & Johnson Devices	QbD
Team Member	Allen Heller	Pharma Study Design	QbD
Team Member	Janet Hietshetter	Dystonia Medical Research Foundation	QbD
Team Member	Heather Jorajuria	Genentech - a Member of the Roche Group	QbD
Team Member	Jeffrey Kasher	Eli Lilly and Company	QbD
Team Member	Kathy Kopnisky	National Institutes of Health	QbD
Team Member	Trudie Lang	University of Oxford	QbD
Team Member	Lisa LaVange	Food and Drug Administration	QbD
Team Member	Michael Lincoff	Cleveland Clinic Coordinating Center for Clinical Research	QbD
Team Member	Ted Lystig	Medtronic	QbD
Team Member	Danica Marinac-Dabic	Food and Drug Administration	QbD
Team Member	Ann Meeker-O'Connell	Johnson and Johnson Pharmaceutical Research Development	QbD
Team Member	Roxana Mehran	Mt. Sinai Medical Center	QbD
Team Member	Jules Mitchel	Target Health Inc.	QbD
Team Member	David Nickerson	Pfizer Inc.	QbD
Team Member	Richard Ohye	University of Michigan	QbD
Team Member	Ileana Pina	Montefiore Medical Center	QbD
Team Member	Ellen Pinnow	Food and Drug Administration	QbD
Team Member	Tejashri Purohit-Sheth	Food and Drug Administration	QbD
Team Member	Eric Richardson	Food and Drug Administration	QbD
Team Member	David Rodin	Pfizer Inc	QbD
Team Member	Daniel Rose	Pulmonary Fibrosis Foundation	QbD
Team Member	Peter Scheimann	Widler & Schiemann AG	QbD
Team Member	Tamara Shipman	St. Jude Medical	QbD
Team Member	Ken Sprenger	Pfizer Inc	QbD
Team Member	Fergus Sweeney	European Medicines Agency	QbD
Team Member	James Tcheng	Duke University	QbD
Team Member	Robert Temple	Food and Drug Administration	QbD
Team Member	Jean Toth-Allen	Food and Drug Administration	QbD
Team Member	Spiros Vamvakas	European Medicines Agency	QbD
Team Member	Roseann White	Abbott Vascular	QbD
Team Member	Beat Widler	Widler & Schiemann AG	QbD
Project Manager	Zach Hallinan	Clinical Trials Transformation Initiative	QbD Adoption
EC Champion	John Alexander	Duke University	QbD Adoption
EC Champion	Donna Cryer	Global Liver Institute	QbD Adoption
Team Leader	Ansalan Stewart	Food and Drug Administration/CDER	QbD Adoption
Team Leader	Louise Bowman	University of Oxford	QbD Adoption
Team Leader	Karlin Schroeder	Parkinson's Foundation	QbD Adoption
Team Leader	Coleen Glessner	Alexion	QbD Adoption
Team Leader	Kerstin Koenig	EMD Serono	QbD Adoption
Team Member	Craig Reist*	Duke University	QbD Adoption
Team Member	David Rodin	Amici Clinical Research	QbD Adoption
Team Member	Margaret Schneider	University of California, Irvine	QbD Adoption
Team Member	Fergus Sweeney	European Medicines Agency	QbD Adoption
Team Member	Mary Taylor	Becton, Dickinson and Company	QbD Adoption
Team Member	Austin Allan	Kura Oncology, Inc.	QbD Adoption
Team Member	Prajna Kumar	Alexion	QbD Adoption
Team Member	Liz Adams	Quorum Review IRB	QbD Adoption
Team Member	Keith Barber	Syneos Health	QbD Adoption
Team Member	Kousick Biswas	Department of Veterans Affairs	QbD Adoption
Team Member	Sabrina Comic-Savic	The Medicines Company	QbD Adoption
Team Member	Dan Cooper	University of California, Irvine	QbD Adoption
Team Member	Ryan Fischer	Parent Project Muscular Dystrophy	QbD Adoption
Team Member	Annie Fors	University of Kansas Medical Center	QbD Adoption
Team Member	Coleen Glessner	Alexion Pharmaceuticals, Inc	QbD Adoption
Team Member	Dagmar R Görtz	Janssen	QbD Adoption
Team Member	Martin Hamilton	Food and Drug Administration/CDRH	QbD Adoption
Team Member	Jan Hewett	Food and Drug Administration/CDER	QbD Adoption
Team Member	Helen Howitt	Syneos Health	QbD Adoption
Team Member	Irfan Khan	Food and Drug Administration/CDRH	QbD Adoption
Team Member	Stacey Lallier	Johnson & Johnson/Janssen	QbD Adoption
Team Member	Martin Landray	University of Oxford, CTSU	QbD Adoption
Team Member	Marion Mafham	University of Oxford	QbD Adoption
Team Member	Ann Meeker-O'Connell	Vertex Pharmaceuticals Inc	QbD Adoption
Team Member	Hamid Moradi	University of California, Irvine	QbD Adoption
Team Member	Jamie Phalp	University of Kansas Medical Center	QbD Adoption
Team Member	Petra Rathje	Amgen, Inc.	QbD Adoption
Recommendations Advisory Commitee	John Alexander	Duke University	QbD Adoption
Recommendations Advisory Commitee	Karin Freda	Johnson & Johnson/Janssen	QbD Adoption
Recommendations Advisory Commitee	James Gibaldi	MJFF	QbD Adoption
Recommendations Advisory Commitee	Sameera Ibrahim	IQVIA	QbD Adoption
Recommendations Advisory Commitee	Hallie Kassan	Northwell	QbD Adoption
Recommendations Advisory Commitee	Xavier Lefebvre	Medtronic, Inc.	QbD Adoption
Recommendations Advisory Commitee	David Nickerson	EMD Serono	QbD Adoption
Recommendations Advisory Commitee	Janette Panhuis	McMaster	QbD Adoption
Recommendations Advisory Commitee	Vinod Parthasarathy	Medtronic, Inc	QbD Adoption
Recommendations Advisory Commitee	Lauren Tochacek	Duke University	QbD Adoption
Recommendations Advisory Commitee	Joseph Verbalis	Georgetown University	QbD Adoption
Project Manager	Cheri Janning	Clinical Trials Transformation Initiative	QbD Monitoring
Team Leader	Martin Landray	University of Oxford	QbD Monitoring
Team Leader	Briggs Morrison	Pfizer, Inc.	QbD Monitoring
Team Leader	David Nickerson	Pfizer, Inc.	QbD Monitoring
Team Leader	Melissa Robb	FDA/CDER	QbD Monitoring
Team Leader	Rachel Sherman	FDA/CDER	QbD Monitoring
Team Member	Brenda Aker	Biosense Webster	QbD Monitoring
Team Member	Kathy Beaver	Medtronic, Inc.	QbD Monitoring
Team Member	Mark Behm	AstraZeneca Pharmaceuticals LP	QbD Monitoring
Team Member	Sandra Benton	FDA/CDER	QbD Monitoring
Team Member	Alex Boddy	Sanofi-Aventis	QbD Monitoring
Team Member	Chrissy Cochran	FDA/CDRH	QbD Monitoring
Team Member	Susan Donahue	PMG Research, Inc.	QbD Monitoring
Team Member	Miriam (Bunny) Donohue	Duke University	QbD Monitoring
Team Member	Christine Drabick	FDA/CBER	QbD Monitoring
Team Member	Jennifer Giangrande	Genentech-a member of the Roche Group	QbD Monitoring
Team Member	Joseph Griffin	FDA/CDER	QbD Monitoring
Team Member	Joan Harley	Training Extension	QbD Monitoring
Team Member	Debby Holmes	ICON	QbD Monitoring
Team Member	Cynthia Kleppinger	FDA/CDER	QbD Monitoring
Team Member	An Liu	A and L Consulting, LLC	QbD Monitoring
Team Member	Debra Madden	Individual Patient/Caregiver	QbD Monitoring
Team Member	Clare Matti	Duke University	QbD Monitoring
Team Member	Robert McCormick	PPD	QbD Monitoring
Team Member	Paula McKeever	FDA/CDER	QbD Monitoring
Team Member	Jules Mitchel	Target Health, LLC	QbD Monitoring
Team Member	James Neaton	University of Minnesota	QbD Monitoring
Team Member	Ray Policare	Amgen Inc	QbD Monitoring
Team Member	Julian Rimmer	ICON	QbD Monitoring
Team Member	Norman Stockbridge	FDA/CDER	QbD Monitoring
Team Member	Craig Wozniak	GSK	QbD Monitoring
Team Member	Cynthia Zacharias	BMS	QbD Monitoring

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.

Resources

Regulatory Submissions + Approvals | CTTI News

Webinar Recording Available: Listen to Best Practices on Conducting Clinical Trials during COVID-19

Regulatory Submissions + Approvals | CTTI News

Webinar on Best Practices on Conducting Clinical Trials during COVID-19

Regulatory Submissions + Approvals | CTTI News

Webinar Now Available: Findings & Reflections from CTTI’s ICH E6 Renovation Work

A recording is now available of a CTTI webinar on new stakeholder-informed research to identify areas within ICH E6 GCP that are in the greatest need of renovation. The webinar, held Thurs.,...

Ensuring Quality | Resources

Survey Findings: Informing the Renovations to the ICH E6 GCP Guideline

Ensuring Quality | Resources

Open Comment Findings: Informing the Renovations to the E6 GCP Guideline

Ensuring Quality | Resources

Interview Findings: Informing the Renovations to the ICH E6 GCP Guideline

Regulatory Submissions + Approvals | CTTI News

Webinar to Provide Findings & Reflections from CTTI’s ICH E6 Renovation Work

Ensuring Quality

Quality By Design

Avoiding errors, collecting data that is fit-for-purpose, and reducing patient burden are just a few of the many benefits of applying Quality by Design (QbD)—an approach that focuses resources on...

Ensuring Quality

Informing ICH E6 Renovation

Our work to improve the quality and efficiency of clinical trials goes beyond the U.S. borders.

Patient Engagement

Diversity in Clinical Trials

The underrepresentation of diverse populations in clinical trials creates knowledge gaps about the risks and benefits of drugs and devices and undermines public trust in research.

Refine Your Selection

Formats

Stage of Trial

Informing ICH E6 Renovation

Topics Included: Ensuring Quality

SHARE TO:

Our work to improve the quality and efficiency of clinical trials goes beyond the U.S. borders. Recently, CTTI conducted several efforts to help inform the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as it revises ICH E6 Good Clinical Practice (GCP):

Through a global survey with 327 research professionals from 154 countries, in-depth interviews, and a public open comment period, CTTI issued a report outlining the areas requiring the most focus pertaining to sponsors, essential documents, and investigators.
CTTI co-hosted a public event with the FDA to help the ICH in its efforts to improve various topics within GCP.
CTTI also convened two public web conferences hosted by the ICH that provided an update on the progress to revise this important and impactful guideline.

Project Team Members

Role	Name	Affiliation
Project Manager	Pamela Tenaerts*	Clinical Trials Transformation Initiative
Social Science Lead	Amy Corneli	Clinical Trials Transformation Initiative
Team Member	Melissa Bomben	Syneos Health
Team Member	Lawrence Calais	Department of Veterans Affairs
Team Member	Jiyoung Choi	Northwell Health
Team Member	Fred Feldstein	Johnson & Johnson/Janssen
Team Member	Pamela Gonzalez	Department of Veterans Affairs
Team Member	Patricia Hurley	American Society of Clinical Oncology
Team Member	Ji-Eun Kim	Northwell Health
Team Member	Martin Landray	University of Oxford
Team Member	Peter Marks	Merck & Company, Inc.
Team Member	Sarah Mizrahi	Medidata Solutions
Team Member	Theresa Mullin	Food and Drug Administration/CDER
Team Member	Janette Panhuis	Population Health Research Institute-McMaster University
Team Member	James Riddle	Quorum Review IRB
Team Member	Michele Russell-Einhorn	Advarra
Team Member	Maryam Sadat	Amgen Inc.
Team Member	Fergus Sweeney	European Medicines Agency

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.

Resources

Regulatory Submissions + Approvals | CTTI News

Webinar Recording Available: Listen to Best Practices on Conducting Clinical Trials during COVID-19

Regulatory Submissions + Approvals | CTTI News

Webinar on Best Practices on Conducting Clinical Trials during COVID-19

Regulatory Submissions + Approvals | CTTI News

Webinar Now Available: Findings & Reflections from CTTI’s ICH E6 Renovation Work

A recording is now available of a CTTI webinar on new stakeholder-informed research to identify areas within ICH E6 GCP that are in the greatest need of renovation. The webinar, held Thurs.,...

Ensuring Quality | Resources

Survey Findings: Informing the Renovations to the ICH E6 GCP Guideline

Ensuring Quality | Resources

Open Comment Findings: Informing the Renovations to the E6 GCP Guideline

Ensuring Quality | Resources

Interview Findings: Informing the Renovations to the ICH E6 GCP Guideline

Regulatory Submissions + Approvals | CTTI News

Webinar to Provide Findings & Reflections from CTTI’s ICH E6 Renovation Work

Ensuring Quality

Quality By Design

Ensuring Quality

Informing ICH E6 Renovation

Our work to improve the quality and efficiency of clinical trials goes beyond the U.S. borders.

Patient Engagement

Diversity in Clinical Trials

The underrepresentation of diverse populations in clinical trials creates knowledge gaps about the risks and benefits of drugs and devices and undermines public trust in research.

Refine Your Selection

Formats

Stage of Trial

Diversity in Clinical Trials

Topics Included: Access to Clinical Trials, Patient Engagement

SHARE TO:

The underrepresentation of diverse populations in clinical trials creates critical knowledge gaps about the safety and effectiveness of medical products—and erodes public trust in research. To help change this, CTTI conducted a project aimed at improving access to clinical trials and increasing the inclusion of underrepresented populations. The resulting recommendations and resources are designed to help organizations implement practical, system-level changes that lead to more diverse participation and research findings that better reflect the needs of all people.

What is the Issue?

Underrepresentation of racial minorities, ethnic minorities, and women in U.S. clinical trials limits knowledge of investigational medical products’ (IMPs) safety and efficacy, reducing the availability of evidence-based treatment guidelines for underrepresented populations. Despite ample scientific evidence of treatment response differences in underrepresented populations and numerous initiatives to increase diversity in clinical trials, systemic change remains elusive—presenting the clinical trial ecosystem with a serious human subject protection issue and a broader public health threat.

Over time, awareness and support for patient centricity in clinical trials has increased. However, commitment to creating targeted, scientifically driven strategies to increase the participation of underrepresented patient populations in clinical trials remains insufficient. Gaps in knowledge about the value and impact of initiatives to increase diversity in clinical trials weakens resolve to allocate necessary resources to the development of clinical trial infrastructures that address the needs of diverse patient populations.

CTTI’s project aims to address this gap through generating resources that demonstrate the value of increasing diverse patient populations’ participation in the development of drugs and devices—from initial target identification to clinical trial conduct.

What CTTI project has been inititated to address the issue?

What are the objectives of CTTI's work on Diversity?

Identify organizational-level practices, and related metrics, that increase the inclusion of diverse patient populations in the development lifecycle of medical products.
Identify incentives & disincentives for decision makers to invest sufficient resources in
organizational-level practices that increase diversity in clinical trials.
Identify factors that yield clinical, scientific, and financial return on investment from
engaging diverse populations in clinical trials.

What is the anticipated impact of CTTI's work on Diversity?

Project Team Members

Role	Name	Affiliation
EC Champion	Robert Temple	Food and Drug Administration/CDER
Project Manager	Sara Calvert	Clinical Trials Transformation Initiative
Communications Lead	Rae Holliday	Clinical Trials Transformation Initiative
Social Science Lead	Amy Corneli	Clinical Trials Transformation Initiative
Team Leader	Bernadete Siddiqi*	The Michael J Fox Foundation for Parkinson's Research
Team Leader	Dawn Corbett	National Institutes of Health
Team Leader	Luther Clark	Merck & Company, Inc
Team Leader	Richardae Araojo	Food and Drug Administration/OC
Team Leader	Tesheia Johnson	Yale University
Team Member	Arisha Ali	Amgen Inc
Team Member	Beverly Lorell	King & Spalding LLP
Team Member	Cassandra Beisel*	Melanoma Research Foundation
Team Member	Cassandra Smith*	Johnson & Johnson/Janssen
Team Member	Cecilia Belmonte*	Amgen Inc
Team Member	Christina Brennan	Northwell Health
Team Member	Coleman Obasaju	Eli Lilly and Company
Team Member	Dinorah Villanueva	Johnson & Johnson/Janssen
Team Member	Diana Foster	Society for Clinical Research Sites
Team Member	Glendon Zinser	Susan G Komen
Team Member	Heidi Pereira	Novartis
Team Member	Jaime Arango	CITI Program, a Division of BRANY
Team Member	Jamil Rivers	Individual Patient/Caregiver
Team Member	Jane Williams	Syneos Health
Team Member	Jeffrey Sherman	Drug Information Association
Team Member	Jerrihlyn McGee	University of Kansas Medical Center
Team Member	Julia Yegorova	Genentech-a member of the Roche Group
Team Member	Karlin Schroeder	Parkinson's Foundation
Team Member	Katy Sadowski	TrailSpark
Team Member	Kaveeta Vasisht	Food and Drug Administration/OC
Team Member	Kelley O'Donoghue	University of Rochester
Team Member	Kevin Thomas	Duke University
Team Member	Kimberly Carlson	Department of Veterans Affairs
Team Member	Kimberly Fisher	Janssen
Team Member	Maria Ali	The George Institute for Global Health
Team Member	Melania Boyce	EMD Serono
Team Member	Natalie Holick	University of Kansas Medical Center
Team Member	Patricia Hurley	American Society of Clinical Oncology
Team Member	Patricia Jones	National Institutes of Health
Team Member	Ruma Bhagat	Genentech-a member of the Roche Group
Team Member	Susan Burriss	GlaxoSmithKline
Team Member	Suzanne Maahs	Novartis
RAC Member	Alyssa O'Grady	MJFF
RAC Member	Emmelyn Kim	Northwell Health
RAC Member	Karen Peterson	Karen's Club
RAC Member	Kim Fookes	Novartis
RAC Member	Kousick Biswas	Department of Veterans Affairs
RAC Member	Linda Davidson-Ray	Duke University
RAC Member	Reem Yunis	Medable
RAC Member	Ubong Peters	Genentech - a member of the Roche Group

Organization affiliations are listed as active affiliations during the project.