Milken Institute Statement on Newly Released FDA Guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Trials
The Milken Institute celebrates the publication of the second iteration of the Food and Drug Administration (FDA) draft guidance on Diversity Action Plans (DAP) to improve clinical trial diversity by enrolling underrepresented populations in the US.
FasterCures at the Milken Institute has been at the forefront of advancing health equity across the biomedical innovation ecosystem. In 2020, FasterCures initiated a body of work focused on developing strategies and policies to increase diversity and inclusion in all stages of clinical research and to change the culture of systems within the biomedical research community to value diversity and representation in the development and execution of clinical trials.
We also supported and applauded the inclusion of the DEPICT Act in the Food and Drug Omnibus Report Act of 2022 (FDORA), which aimed to remove barriers and improve diversity and inclusion in populations to involve participants in clinical trials mirroring the prevalence and incidence of diseases and conditions.
We believe the draft guidance created a pathway for diverse and inclusive clinical trials, particularly with the recommendations below within the guidance.
The expanded categories for enrollment of underrepresented populations in the US include race, ethnicity, sex, and age, and disaggregated enrollment is required for categories.
The FDA also encouraged sponsors to consider geographic locations, gender identity, sexual orientation, physical and mental disabilities, pregnancy status, lactation status, and co-morbidity as factors when developing the DAP.
The FDA recommended that sponsors increase the proportional enrollment of a certain population (over-enrollment) to evaluate outcomes or other relevant factors in that group if they think certain populations might respond differently to the medical product.
The guidance clarified that the prevalence or incidence among the US intended use population should be the foundation for determining the enrollment goals, except for products like vaccines targeting the entire population. For the latter, US Census data can be used. It encourages the industry to have ownership and leadership in designing clinical trials based on such data.
For multi-regional clinical studies, the DAP requires the description of the participant enrollment goals for the entire study, not limited to US-enrolled participants. It also requires site selection to account for the need to enroll a population representative of the US intended use population.
We want to emphasize the key points below, which might need additional clarification and enforcement.
It would be important to clarify what protocols the FDA would put in place if the enrollment goals were not met despite the best efforts from an industry sponsor. The first iteration of the draft guidance states, “In the event that recruitment goals are not met despite best efforts, sponsors should discuss with the FDA a plan to collect this data in the post-marketing setting.” This point is not repeated in the second draft guidance.
The guidance states that sponsors should consider that "certain demographic groups may have a different response to medical products based on factors such as differential pharmacokinetics (PK), pharmacodynamics (PD),” etc. Although the FDORA requires sponsors to submit the DAP for phase 3 or other pivotal studies, it is essential to highlight that PK/PD studies are conducted in phases 1 or 2. These analyses determine an appropriate dose for a clinical trial. It will be necessary for the FDA and sponsor to ensure these factors are considered when setting enrollment goals.
“We look forward to working with the FDA to refine the guidance to maximize the full potential of the Diversity Action Plans,” said Esther Krofah, executive vice president of health at the Milken Institute. “It is imperative that clinical trials, and thus access to potential treatments and interventions, reflect prevalence and incidence of US intended population, including communities of color and other historically underrepresented populations.”
Albert Bourla, Anthony Fauci, Margaret Hamburg among 175+ speakers Washington, DC – Dec. 6, 2020 – The Milken Institute Future of Health Summit kicks off tomorrow, drawing more than 1,000 leaders from government, science, education...
BD 2 commits to finding answers for the 40 million individuals with bipolar disorder and those not yet diagnosed Washington, D.C. – September 12, 2022 – Today, three family philanthropies joined with the Milken Institute to commit $150...
Chad Clinton is the director of media relations for the Milken Institute. Hired to this role in August 2021, Clinton develops and executes strategies to amplify the Institute’s core messages by generating coverage of its pillar workstreams, experts, and events.
Washington D.C., USA, December 19, 2023—To help strengthen local capital markets, IFC and the Milken Institute have joined forces with Georgetown University’s McDonough School of Business to provide advanced knowledge and skills training to...
Paul Guequierre is the director of strategic communications. In this role, he works to increase the profile of Milken Institute in the media, raise the visibility of issues important to the organization and its stakeholders, and expand the Institute's digital presence.
Washington, DC – June 18, 2021 – The Milken Institute today released a set of strategies outlining how corporations, large financial institutions, philanthropic organizations, and governments can leverage mission-focused lenders to better...
New report calls for leveraging Minority Depository Institutions and Community Development Financial Institutions to better meet the needs of underserved communities.
New report from Alliance to Improve Dementia Care highlights health- and long-term care systems, communities, and workplaces. Washington, D.C. – March 31, 2021 – The Milken Institute today released recommendations to reduce disparities in...
Rajiv Ahuja is a director for the MI Health Future of Aging team where he focuses on aging policies and programs that support healthy longevity. Ahuja’s mission is to create lasting change through research, advocacy, and the formation of impact coalitions.
Washington, DC (November 16, 2022) – The 4th annual Milken Institute Middle East and Africa Summit returns to Abu Dhabi November 17-18 for the first time in more than two years. The summit will gather hundreds of attendees, including C...
Chad Clinton is the director of media relations for the Milken Institute. Hired to this role in August 2021, Clinton develops and executes strategies to amplify the Institute’s core messages by generating coverage of its pillar workstreams, experts, and events.
Los Angeles – August 5, 2020 – The Milken Institute Global Conference, an annual convening of global leaders in government, finance, health, academia, and philanthropy, will go fully virtual this fall from October 12-21, 2020. Building on...
Washington, DC – June 21, 2021 – The Milken Institute Future of Health Summit kicks off tomorrow, drawing more than 1,000 leaders from government, academia, business, philanthropy, tech, and the private sector. Over the course of two days...
House Speaker Nancy Pelosi, HHS Secretary Alex Azar among new speakers added; Major Research on Alzheimer’s Disease, Dementia and more to be released WASHINGTON, October 28, 2019 – The Milken Institute Future of Health Summit opens today in...
The four-day, in-person event features nearly 600 speakers whose expertise and creativity are reinventing health, finance, technology, philanthropy, industry, and media. Los Angeles – October 16, 2021 – The 24th annual Milken Institute...
Chad Clinton is the director of media relations for the Milken Institute. Hired to this role in August 2021, Clinton develops and executes strategies to amplify the Institute’s core messages by generating coverage of its pillar workstreams, experts, and events.
The livestreamed eight-day event features nearly 500 speakers, including top business leaders, health and government officials, activists, entertainers, influencers and more. Los Angeles – October 11, 2020 – The 23rd annual Milken Institute...
LOS ANGELES, August 7, 2018 – The challenge of fixing America’s deteriorating infrastructure and making it more resilient to the effects of extreme weather and climate change underscores the need for a more robust green bond market...