Advancing Clinical Trial Diversity: A Step Towards Equitable Healthcare

The lack of diversity in clinical trials has long been a concern, leading to adverse side effects and health disparities among various racial and ethnic groups, as well as women. Historically, clinical trials have disproportionately included white men as participants, which limited our understanding of how drugs and treatments affect different populations.

This article explores the reasons for the lack of diversity in clinical trials and examines the steps being taken to promote inclusivity, containing revised inclusion criteria, outreach, diverse recruitment strategies, data analysis, and updated guidelines and regulations. Increasing diversity in clinical trials is crucial to ensuring that medical treatments are effective and safe for all populations, ultimately improving health outcomes and reducing disparities.

There are several reasons why lack of diversity occurs:

1. Historical practices: In the past, clinical trials were too often conducted on white men because they were seen as the “standard” population. This historical bias has persisted, leading to underrepresentation of other groups.
2. Barriers to participation: Certain racial and ethnic groups and women may face barriers to participating in clinical trials. These barriers can include language barriers, lack of trust in the medical system, financial constraints, and cultural factors.
3. Generalization of results: When clinical trials are predominantly conducted on one group, the results may not be easily applicable to other populations. Differences in genetics, physiology, and metabolism can affect how drugs are absorbed and processed, leading to varying responses and side effects.
4. Underdiagnosis and undertreatment: Lack of representation in clinical trials can contribute to underdiagnosis and undertreatment of certain health conditions in specific populations.

To address these issues and promote better representation and understanding of drug effects, researchers, regulatory agencies, and medical institutions are increasingly recognizing the importance of diversity in clinical trials.

In December of 2022, the US Congress passed the omnibus spending legislation to provide funding for the federal government through September 2023. The legislation contains numerous reforms focused on FDA bundled under Title III, the Food and Drug Omnibus Reform Act of 2022, or FDORA. Among the many provisions is chapter 1 of subtitle F, Clinical Trial Diversity and Modernization, which amends the FDORA to require drug and device sponsors to submit diversity action plans articulating goals for increasing enrollment of subjects from historically underrepresented populations.

These provisions reflect the principles outlined in FDA’s April 2022 draft guidance “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” and previous agency guidance documents focused on clinical trial diversity, and expand the scope of characteristics required to be considered in a diversity plan.

The FDA has been actively encouraging diversity in clinical trials. They have issued guidance to emphasize the importance of diverse representation in clinical research and have highlighted the need for demographic data collection to ensure that clinical trial results are generalizable to various populations.

Additionally, the FDA’s Prescription Drug User Fee Act (PDUFA) includes provisions that aim to enhance diversity in clinical trials. These provisions enable the FDA to collect fees from pharmaceutical companies to fund certain activities, including efforts to improve the diversity of clinical trial participants.

Steps are being taken to ensure that clinical trials are more inclusive and representative of the population:

1. Inclusion criteria: Researchers are expanding their inclusion criteria to better reflect the diversity of the population. This includes considering various age groups, genders, and racial and ethnic backgrounds.
2. Outreach and education: Efforts are being made to reach out to underrepresented communities, raise awareness about clinical trials, and educate potential participants about their importance and safety.
3. Diverse recruitment strategies: Researchers are using various recruitment strategies, including partnering with community organizations and healthcare providers, to increase participation from diverse populations.
4. Data analysis: Researchers are paying more attention to subgroup analysis to understand how drugs might affect different populations differently.
5. Guidelines and regulations: Regulatory agencies are encouraging or requiring more diverse representation in clinical trials to ensure the safety and efficacy of drugs for all populations.

As societal expectations evolve, regulatory agencies may incorporate diversity and inclusion considerations into their evaluation of drug development programs. While not explicit in FDORA and PDUFA, these expectations may become more relevant in future updates to drug development regulations.

It’s important for drug developers to be aware of the broader industry trends and initiatives related to diversity and inclusion. Incorporating diverse perspectives in all aspects of drug development, from preclinical research to clinical trials and post-marketing, can lead to more effective and inclusive healthcare solutions.

If you have any questions or want to find out more about how Cromos Pharma can support your next clinical trial please contact us by emailing inquiry@cromospharma.com.