Related: Diversity

Increasing Diversity in Clinical Trials Expert Meeting

OCTOBER 12 & 21, 2021

CTTI Project: Diversity

Meeting Objectives:

  • Present findings from project evidence generation: in-depth interviews with key decision-makers.
  • Refine a maturity model for organizational-level strategies to increase diversity in clinical trials.
  • Identify specific multi-stakeholder, portfolio-level strategies to increase the participation of underrepresented racial and ethnic minorities and women in clinical trials.

Meeting Location: Virtual Meeting

Meeting Summary

Meeting Agenda

List of Meeting Attendees

Pre-Meeting Materials

Meeting Materials:

Day 1

 

Day 2

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Increasing Diversity in Clinical Trials Recommendations Launch

CTTI Project: Increasing Diversity in Clinical Trials

Webinar Presenters:

  • Richardae Araojo, U.S. Food & Drug Administration (FDA)
  • Ruma Bhagat, Genentech - a member of the Roche Group
  • Sara Calvert, CTTI
  • Luther T. Clark, Merck & Co, LLC
  • Dawn Corbett, National Institutes of Health Office of Extramural Research (OER)
  • Tesheia Johnson, Yale University
  • Jane Williams, Syneos Health
  • Glendon Zinser, Susan G. Komen

Webinar Resources:

Download PowerPoint slideset

Report Now Available: Virtual Public Workshop to Enhance Clinical Study Diversity

Posted on by Hannah Faulkner

The report of the two-day virtual public workshop to enhance clinical study diversity, convened by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. The workshop was held on November 29 and 30, 2023 with more than 2,600 global attendees. 

The workshop solicited input on strategies and considerations for increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of diseases or conditions among demographic subgroups. Speakers and panelists included representatives from the FDA and other federal agencies, academia, medical device and pharmaceutical sponsors, patients and patient advocacy groups, and research study teams. 

The workshop fulfilled a requirement under section 3603 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). View the recording and slide deck to learn more. 

Recording of Virtual Public Workshop Now Available: Enhancing Diversity in Clinical Studies

Posted on by Hannah Faulkner

A recording for the virtual public workshop to enhance clinical study diversity convened by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held November 29 and 30, is now available.  

Day 1 of the virtual public workshop opened with welcoming remarks from Karen A. Hicks, Deputy Director of the FDA’s Office of Medical Policy (OMP). Following the opening remarks, Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research (CDER), delivered the keynote address. Following the keynote, multiple speaker presentations and panel discussions were held, including topics such as an overview of clinical study diversity, establishment of clinical study enrollment goals, approaches to support the inclusion of underrepresented populations in clinical studies, and more. The first day concluded with closing remarks from Karen Hicks.    

Day 2 of the workshop began with opening remarks from Mathilda Fienkeng, Director of the FDA’s Division of Medical Policy Development at the OMP. Following the opening remarks, further presentations and panel discussions were held on approaches to support the inclusion of individuals with mental illness in clinical trials, how to use digital health tools to increase clinical study diversity, community engagement, and next steps to enhance clinical study diversity with respect to the FDA’s overall mission. The second and final day of the workshop concluded with closing remarks from Hicks. 

View the full slide deck to learn more about the methods to support the inclusion of various underrepresented populations in clinical studies.  

This workshop fulfilled a requirement under section 3603 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). 

CTTI Publication Investigates Organizational Practices to Promote Diversity and Inclusion in Clinical Trials

Posted on by Hannah Faulkner

A new CTTI publication, published in the Journal of Clinical Pharmacology & Therapeutics, investigates organizational-level practices for enhancing diversity and inclusion in clinical trials as one component of advancing health equity and improving health outcomes. When clinical trial participants do not reflect the populations that will use the medical product, it can limit our understanding of the safety and efficacy of the investigational medical product, restrict the availability of evidence-based treatment guidelines for vulnerable populations disproportionally burdened by disease, and delay access to innovative and potentially life-extending therapies.  

CTTI interviewed 36 senior-level leaders at 20 organizations that conduct clinical trials to gather perspectives on strategies to support diversity and inclusion in clinical research. Based on these interviews and a 2-day meeting with 53 experts, CTTI identified four key action areas to implement sustainable, organizational-level practices: commitment, partnerships, accountability, and resources. To improve equitable access and increase diversity in clinical trial populations, CTTI suggests making diversity and inclusion in clinical trials an organizational priority and defining responsibility for these efforts, establishing and maintaining bi-directional community partnerships, and allocating organizational resources that support diversity and inclusion in clinical research. The CTTI Diversity Project Team is using the findings from this research to develop recommendations and a tool for institutions to use to initiate or enhance their diversity and inclusion efforts.