Advancing Diversity and Inclusion in Clinical Trials: FDA’s strategic framework

The integrity and applicability of clinical trial outcomes rely heavily on the inclusion of diverse populations. This helps to ensure equity in healthcare advancements across demographic groups. Historically, clinical trials have faced gaps in representation, failing to reflect the broader population. To address these disparities, the U.S. Food and Drug Administration (FDA) has implemented strategic initiatives aimed at fostering inclusivity and equity in clinical research.

The Need for Diversity in Clinical Trials

Representation in clinical trials is essential to ensure that the outcomes are applicable and beneficial to diverse populations. If a study does not account for a broader demographic, the resulting drug or treatment could have adverse effects for the neglected group. Including a diverse population in the study acknowledges the variability in genetic, epigenetic, environmental, and socio-cultural aspects that can potentially influence the treatment efficacy. Furthermore, equitable access to innovations can benefit the underserved populations, who are disproportionately affected by certain health conditions. Lastly, inclusivity in clinical research aligns with ethical mandates and promotes the credibility of study outcomes. Despite this recognized importance, multiple barriers persist in ensuring diversity and inclusivity in clinical trials.

Barriers in Ensuring Diversity in Clinical Trials

Numerous systemic, social, and logistical barriers hinder the participation of underrepresented groups, affecting efforts to create equitable and inclusive research. Here are a few:

1. Lack of Trust:

Certain racial and ethnic minorities often mistrust medical research and clinical trials due to historical injustices, stigma associated with participation, or miscommunication by investigator. Furthermore, infamous cases such as the Tuskegee Syphilis Study can contribute to the public mistrust towards these studies.

2. Logistical Constraints:

Challenges related to transportation and proximity to trial sites disproportionately affect marginalized communities. Moreover, language barriers can pose significant challenges, as non-native speakers may struggle to understand trial protocols or consent forms.

3. Limited Awareness

Many individuals, especially in underserved communities, are unaware that clinical trials are an option and could potentially treat their medical conditions. Furthermore, misconceptions about clinical trials, such as fear of being treated as “guinea pigs” discourage participation by a wider community.

While several factors form a barricade in ensuring diversity of clinical trials, several initiatives aim to bridge this gap.

FDA Initiatives to Promote Inclusivity

Since 2016, FDA has organized several initiatives and created documents aimed at promoting DEI in clinical trials. To address representation issues in clinical trials, FDA has adopted a multi-faceted approach.

1. Defining the Requirements and Enrolment Goals

A draft published in 2024 outlines the requirements for Diversity Action Plans, including the need to specify enrollment goals and their implementation for clinical studies, disaggregated by race, ethnicity, sex, and age group, and to include a rationale for these goals. Sponsors must also include measures to improve study participant awareness, reduce participant burden, and improve access to the clinical study.

2. Broadening Eligibility Criteria

FDA’s 2020 guidance document suggests to broaden the eligibility criteria to promote diverse participation. Restrictive criteria, such as strict age limits or health status requirements, can needlessly exclude participants who could benefit from or contribute to research.

3. Promoting Community Engagement and Education

Through the Office of Minority Health and Health Equity (OMHHE), the FDA conducts targeted outreach to build trust and disseminate information about clinical trial participation. OMHHE aims to promote equity in health. it works to educate individuals about the benefits and safety of clinical trials, emphasizing the importance of participation in advancing health equity.

4. Promoting Technological Innovations

The FDA advocates for the use of decentralized trial designs and digital health technologies to mitigate logistical barriers and expand access for remote populations. Digital health technologies, such as wearable devices and mobile apps, facilitate real-time data collection and remote monitoring of patients. This reduces logistical barriers, making participation more accessible for remote and underserved populations.

5. Documenting Properly

The FDA’s 2016 guidance standardizes the collection of demographic data, including age, sex, gender, race, and ethnicity, to ensure consistency across federal agencies. Based on OMB Directive 15 and the Affordable Care Act, it applies to clinical trials conducted in the U.S. and abroad. The guidance recommends a two-question format for race and ethnicity, with ethnicity asked first, and provides minimum category options. This framework improves the quality and completeness of demographic data while promoting uniformity in its use.

While the FDA’s initiatives provide a solid foundation, achieving meaningful diversity requires a collective effort from the industry stakeholders, healthcare providers, and community advocates to bridge the representation gap. Sponsors must institutionalize diversity as a critical component of trial design and execution and supervisors or healthcare experts should actively educate patients about clinical trials and advocate for their participation. Furthermore, investigators can consider clinical trial translation services to overcome the barriers in clinical trial submissions. Contact now! 

A truly representative clinical trial ecosystem will not only enhance the robustness of scientific findings but also ensure that the benefits of medical advancements are shared equitably among all populations.

References:

1. Clark, Luther T., Laurence Watkins, Ileana L. Piña, Mary Elmer, Ola Akinboboye, Millicent Gorham, Brenda Jamerson, et al. 2019. “Increasing Diversity in Clinical Trials: Overcoming Critical Barriers.” Current Problems in Cardiology 44 (5): 148–72. https://doi.org/10.1016/j.cpcardiol.2018.11.002.

2. “An Overview of FDA Diversity-Related Documents for Clinical Trials.” 2024. Applied Clinical Trials. May 30, 2024. https://www.appliedclinicaltrialsonline.com/view/an-overview-of-fda-diversity-related-documents-for-clinical-trials.

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Author:

Anagha Nair

Editorial Assistant, Enago Academy
Medical Writer, Enago Life Sciences
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