Diversity action plans—focused on enrolling representative numbers of participants in clinical trials from historically underrepresented racial and ethnic populations—are part of U.S. Food and Drug Administration (FDA) draft guidance published in April 2022.{1} “Sponsors, such as Merck, are focused on developing strategies for actionable diversity plans,” says Amanda Bishop, Associate Director, Clinical Trial Diversity Program Lead, at Merck, known as MSD outside the U.S. and Canada. “This is an important part of our commitment to diversity, and to enrolling a diverse body of participants in our clinical trials.”
In her ACRP 2024 presentation on “Diversity Action Plans: Moving from Intentions to Actions” in May at Anaheim, Calif., Bishop described a blueprint for building a diversity action plan, which includes the following key elements as set forth in FDA’s draft guidance:
- Overview of the disease/condition, describing available data from databases and published literature on the pathophysiology of the disease in underrepresented racial and ethnic populations.
- Scope of the medical product development program, including the planned trials or studies that will support safety, effectiveness, and dosage in a future marketing submission. This section should describe the study design, study population, and endpoints.
- Goals for enrollment of underrepresented racial and ethnic participants, with definitions and justifications for the planned enrollment of participants from underrepresented populations.
- Specific plan of action to enroll and retain diverse participants, and the planned use of data to evaluate safety, efficacy, and dosage in these participants. This should include site location and access, community engagement, and plans to reduce potential challenges to participation.
- Status of meeting enrollment goals, and if the sponsor is not able to achieve these goals despite their best efforts, a plan should be provided for collecting data in the post-marketing setting.
“The specific needs of populations, as well as barriers to their participation in clinical research, are identified as part of the planning process,” states Bishop. “This process may involve working with advocacy groups and other organizations to understand potential patients’ voices and experiences. These needs and barriers should be captured in a way that enables action and tracking of progress, for example, using dashboards and other technologies.”
Joining Bishop for the conference session were Michelle Chawla, Diversity Program Lead; Cameron Davis, Associate Director, Clinical Trial Diversity; and LaShanda Gordon, Associate Director, Diversity Program Lead, all from Merck.
“The diversity plan is an important step forward, encouraging mindful development of specific actions and accountability,” Bishop adds. “The ability to move from intentions to actions in support of diversity, equity, and inclusion in clinical research will be vital. There is room for everyone to be involved with diversity planning, with cross-functional collaboration on actionable strategies from the earliest stages at the core of future advances.”
You can now explore photos and blogs from ACRP 2024, as well as access all recorded ACRP 2024 sessions that correspond to your conference registration type (Full, Weekend, or One-Day Registration) in ACRP Learning (go to learning.acrpnet.org/my to access your My Courses Dashboard and please use your ACRP username and password to login). If you did not attend the full conference in Anaheim and would like to access additional sessions, you can purchase Replay Packages of the six content tracks. Please visit the ACRP Course Catalog and filter by “Recorded Conference.”
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Edited by Jill Dawson
