The California Institute for Regenerative Medicine (CIRM) is proud to join 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 This new law builds on draft guidance issued by the FDA in April 2022 and will move the draft forward to finalization and enforcement.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 facilitate increasingly personalized treatments, we need to develop new models for basic and disease research that reflect diverse ancestral backgrounds and sex and ensure that diverse populations are included among donors and research participants.”
For example, low participation of Black Americans in clinical trials is well documented including by the JCO Oncology Practice. The JCO reports that Black Americans constitute at least 13% of the general population in the United States, account for 22% of annual cancer cases, and succumb to prostate, stomach, uterine cancers, and multiple myeloma, at rates twice as high as white people. And yet, Black Americans reflect only 7% of those enrolled in cancer clinical trials.
Addressing Diversity in Clinical Trials at CIRM
CIRM requires plans for inclusion of diverse or underserved demographic groups in the clinical trials we fund.
Proposals for funding (see samples here) must demonstrate an understanding of health disparities associated with the target indication of the study, and plans to:
- Include an inclusive group of participations by race, ethnicity, sex, gender, and age.
- Address any barriers to trial participation faced by underserved demographic groups.
- Guide, as needed, the cultural competency of study researchers.
“We have incorporated the principles of promoting diversity, equity and inclusion in our research funding programs, education programs and future programs,” 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 CIRM’s investments in clinical trials, visit this page on our website. To learn more about participating in a clinical trial, click here.