Clinical trial diversity is the intentional inclusion of a diverse patient population in medical research to propel scientific advancements that benefit all communities. This issue is a top priority among lawmakers, public health officials, scientists, the health care industry, academia, and the medical community. The focus on clinical trial diversity will likely increase as the health care industry works to build trust among marginalized and historically excluded communities to increase their participation in medical research. Trial representation is crucial to developing drugs, treatments, and therapies because it ensures that all medical products are safe and effective for all Americans. Underrepresentation of certain populations in clinical trials creates a dangerous environment because there is no reliable data on how the treatment will affect this person based on age, gender, weight, race, ethnicity, biology, and other variables, which could lead to adverse events. Outside of the patient safety and ethical concerns, approved treatments that haven’t developed under diverse clinical trials cost the American public billions of dollars each year.
Efforts to promote equity in clinical trial participation began in 1993 with the NIH Revitalization Act of 1993 requiring all federally funded clinical research to prioritize the inclusion of women and underserved racial and ethnic groups. Despite this law, between 1993 and 2013, less than 2 percent of cancer studies included enough racial and ethnic group participants to report relevant results. After years of public and industry concern, the FDA is now recommending that sponsors include a plan to increase diversity when proposing clinical trial designs for investigational products. In 2022, the agency has published draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” and recommends that sponsors submit a “Race and Ethnicity Diversity Plan” when submitting an application for an investigational new drug, a biologics license, or an investigational device exemption. This measure is intended to provide a blueprint on how industry can diversify their clinical trials.
As the 118th Congress begins, Continuum Health Group will be monitoring the progression of any legislative efforts to promote diversity, equity, and inclusion (DEI) in clinical trials. In December 2022, President Joe Biden signed a $1.7 trillion omnibus spending package that included several clinical trial-related changes, such as new trial diversity provisions, updates to the FDA’s accelerated approval pathway, and increased FDA funding. The law also directs the FDA to issue final guidance on trial diversity, an effort the agency began last April with a 12-page draft guidance explaining how it would assess diversity plans as significant components of development programs. The FDA itself will receive $3.5 billion in appropriations, a marked boost of $226 million, or 6.5 percent, over fiscal 2022 funding.
Additionally, in 2022, the House of Representatives brought forth the NIH Clinical Trial Diversity Act which would require clinical trial sponsors to write formal diversity plans when they apply for funding from the National Institutes of Health (NIH). Many individuals across both party lines are optimistic that measures to safeguard the public and consumers will be passed in bipartisanship. Continuum Health Group will continue to support efforts to achieve health equity and provide policy analysis, advocacy development, and political strategy to the public and private sector, regardless of political ideology or party identification.
