The California Institute for Regenerative Medicine (CIRM) joins fellow advocates of clinical trial diversity in applauding a new law that will allow the U.S. Food & Drug Administration (FDA) to require diverse representation in clinical trials.
A clinical trial, as defined by the FDA, tests potential treatments in human volunteers to see whether they should be approved for wider use in the general population. CIRM has invested in 88 clinical trials to date.
In December 2022, Congress approved a bill that requires diversity action plans for clinical trials used by the FDA. This new law builds on draft guidance the FDA issued in April 2022 and will move the draft toward finalization and enforcement.
The law follows a 2022 report issued by the National Academies of Sciences, Engineering and Medicine that starkly notes:
“While progress has been made with representation of white women in clinical trials and clinical research, there has been little progress in the last three decades to increase participation of racial and ethnic minority population groups. This underrepresentation is compounding health disparities, with serious consequences for underrepresented groups and for the nation.”
New Requirements for Clinical Trials
Under the law, clinical trial sponsors will be required to submit a diversity action plan to the FDA along with other important trial documents. The plans, according to the law, should contain:
- The sponsor’s goals for clinical study enrollment, disaggregated by age group, sex, and racial and ethnic characteristics.
- The rationale for these enrollment goals, including information about the disease or condition and its prevalence or incidence among various demographics.
- An explanation of how the sponsor intends to meet the goals, including demographic-specific outreach and enrollment strategies, inclusion and exclusion practices, and diversity training for study personnel.
A Major Step Forward
Requiring a clinical trial to expand the representation of diverse people is a major step forward to reverse systemic and structural social inequities in the health care system.
In a study published in Nature Cell Biology, the authors, which included Dr. Maria Millan, CIRM’s President & CEO, summarized:
“To address health disparities and support personalized treatments, we must develop research models that reflect diverse ancestral backgrounds and sex, and ensure diverse donor and participant representation.”
For example, low participation of Black Americans in clinical trials is well documented, including by JCO Oncology Practice. Black Americans make up at least 13% of the U.S. population and account for 22% of annual cancer cases. They also experience prostate, stomach, uterine cancers, and multiple myeloma at twice the rate of white Americans. Yet they represent only 7% of participants in cancer clinical trials.
Addressing Diversity in Clinical Trials at CIRM
CIRM requires plans to include diverse or underserved groups in the clinical trials it funds. Proposals must show understanding of health disparities tied to the study’s target indication and must:
• Include participants diverse by race, ethnicity, sex, gender, and age.
• Address barriers that underserved groups face in joining trials.
• Strengthen cultural competency among study researchers.
“We have built DEI principles into our research funding, education programs, and future initiatives,” Dr. Millan says. “This is essential to ensure that the therapies we support reach all patients in need, especially communities disproportionately affected or underserved.”
To learn more about CIRM’s investments in clinical trials, visit this page on our website. To learn more about participating in a clinical trial, click here.,” Dr. Millan says. “We believe this is essential to ensure that the therapies our support helps advance will reach all patients in need and in particular communities that are disproportionately affected and/or under-served.”
To learn more about participating in a clinical trial, click here.
Diversity in clinical trials is absolutely essential, and it’s encouraging to see the California Institute for Regenerative Medicine (CIRM) and the FDA making strides to address this issue. The new law requiring diversity action plans is a crucial step in ensuring that treatments developed through clinical trials are safe and effective for all populations, not just a select few. Historically, the lack of representation of racial and ethnic minorities in clinical research has compounded health disparities, as noted in the National Academies’ report. This new framework will help bridge that gap by encouraging more inclusive recruitment and trial practices.
CIRM’s commitment to including underserved groups in their funded trials is commendable. Their efforts, combined with the FDA’s new requirements, will help ensure that future therapies are better suited for the full diversity of the population. It’s especially significant considering the striking disparities in health outcomes for certain diseases, such as the higher rates of cancer among Black Americans, who remain underrepresented in clinical research.
I look forward to seeing the positive changes this will bring to medical research and patient care, and I hope more organizations will follow CIRM’s lead in prioritizing diversity, equity, and inclusion in their work.