Minority racial and ethnic groups in the United States remain underrepresented in clinical trials. Often, far fewer of these patients appear in clinical trials than appear in the patient population as a whole.
In April 2022, the Food and Drug Administration (FDA) released draft guidance to help medical product creators create a race and ethnicity diversity plan “to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the United States.”
The plan seeks to improve racial and ethnic diversity in clinical trial enrollment. In doing so, the FDA wants to support the U.S. government’s Cancer Moonshot plan to make cancer care more equitable.
The Race and Ethnicity Diversity Plan
The 2022 draft guidance is not the FDA’s first attempt to help pharmaceutical and medical device companies improve diversity in clinical trial populations. Guidance released in 2015 and 2020 also sought to refine researchers’ approach to diversity.
Early efforts to improve clinical trial diversity, however, failed to reach their goals. In a March 2022 study published in Health Affairs, Angela K. Green and fellow researchers concluded that the FDA’s 2015 action plan fell short of its goal of improving enrollment of Black patients in clinical trials.
The researchers reported that “Black patients remained inadequately represented in clinical trials for drugs, with a median of one-third the enrollment that would be required, whether the trials were started before, during, or after the action plan.” They also found no change in the number of drugs that included data about treatment effects for Black patients before or after the 2015 plan.
The 2022 draft guidance expands on the FDA’s 2016 document “Collection of Race and Ethnicity Data in Clinical Trials.” In the draft, the FDA states that the expansion is intended “to provide detail on what sponsors should include in a Race and Ethnicity Diversity Plan.”
The FDA recommends a Race and Ethnicity Diversity Plan be submitted when:
- An Investigational New Drug (IND) or Investigational Device Exemption (IDE) submission is required.
- Clinical studies are intended to support a section 351(a) marketing submission for a Biologics License Application (BLA) or a section 505(b)(1) or (b)(2) application for an NDA.
- Clinical studies are intended to support a submission for a 510(k) premarket notification, a premarket approval (PMA) application, a De Novo classification request, or a humanitarian device exemption (HDE).
The agency notes it “will evaluate the Race and Ethnicity Diversity Plan as an important part of the sponsor’s development program.” Sponsors can submit a plan at any time; the suggested timelines in the draft guidance are convenient for reviewers, but early efforts to create a plan and get feedback are encouraged, Ferdous Al-Faruque writes in Regulatory Focus.
The draft guidance isn’t the only effort aimed at improving racial and ethnic diversity in clinical trials. Congress has also recently considered several bills, including the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act and the Clinical Trial Diversity Act, write attorneys Bryant M. Godfrey and Tina Papagiannopoulos.
Race and Ethnicity in Clinical Trials
Members of minority groups face barriers to participation in clinical trials, writes ONS Government Affairs Director Alec Stone. These include:
- Lack of access to healthcare or to information about clinical trials and how to participate.
- Constraints related to time, travel, and resources.
- Language, religious, and cultural differences.
- Mistrust of the clinical research system, often stemming from past abuses of minority communities.
Addressing these barriers has often posed challenges for clinical trial teams. In some cases, the best way to address a barrier — such as lack of trust — is to engage the very patients who shy away due to lack of trust. By offering additional guidance on plan creation, the FDA hopes to bolster clinical trial teams’ efforts to reach out to underserved communities.
Addressing barriers to clinical trial participation will require a multi-pronged approach, Vishnu Priyan writes in Clinical Trials Arena. Improving communication with underserved racial and ethnic communities offers one solution. Better data collection and analysis can help clinical trial teams refine their outreach and retention strategies.
While the FDA guidance represents another step toward equitable clinical trial enrollment, some commentators say it doesn’t go far enough. In an opinion piece at STAT, Nicholas Kenny, Keri McDonough, and Stephen Keith recommend several ways the FDA could strengthen its guidance to improve outcomes and provide better support to clinical researchers. Their recommendations include:
- Discussing healthcare and access disparities, such as patient mistrust or lack of access to prior treatments and how these affect a proposed trial.
- Define the meaning of “diverse population.” The FDA’s current guidance uses a broad definition of “diverse population,” encompassing a wide range of data points — information that reflects both immutable characteristics like race and mutable ones like geographic location. Using this data effectively is necessary if researchers are to understand how their products work for real-world patients.
- Include information on how enrollment goals are chosen to “connect enrollment goals to disease epidemiology.”
- Avoid reductionist discussions of patient mistrust. Kenny, McDonough, and Keith note that the FDA’s reference to the Tuskegee experiments in its discussion of patient mistrust may be overly simplistic, “framing a long history of unethical research practices … through a single egregious study.” Rather, they note that research teams need a fuller understanding of how unethical past practices lead to current mistrust.
Whether or not the FDA adopts these recommendations, clinical trial teams can incorporate them into their own plans. By doing so, team members can better understand not only what they seek to accomplish in diversifying their trial enrollment, but why they have set these goals, what challenges may arise in meeting them, and how to respond.
Tools for Tracking Race, Ethnicity, and Other Key Data
The draft guidance issued in April 2022 focuses on race and ethnicity. In the document, however, the FDA acknowledges that diversity is a broader question than race or ethnicity. The FDA recommends that clinical trial teams also track other diversity-related data points, including:
- Sex and gender identity.
- Age.
- Socioeconomic status.
- Disability.
- Pregnancy or lactation status.
- Comorbidity.
Future FDA guidance may focus more closely on these topics, says Praduman Jain, founder and CEO of Vibrent Health. Clinical trial teams can prepare for future guidance and improve the quality of their own data sets by choosing tracking tools that allow for the inclusion of these and other characteristics of clinical trial participants.
In a comment on the proposed guidance, Mary Dwight and JP Clancy of the Cystic Fibrosis Foundation note that data collection and dissemination are essential. They raise concerns that these areas may be overlooked by the proposed guidance, particularly in the area of rare diseases and the need to compile collected diversity data in an interoperable and accessible way. The right digital tools can help clinical trial teams gather relevant data and ensure it remains usable for future research.
Despite efforts to improve racial and ethnic diversity in clinical trial participation, many trials still run without a representative sample of participants from various racial and ethnic backgrounds. The FDA’s guidance seeks to help clinical researchers improve diversity in clinical trials without imposing additional mandates.
Clinical trial teams that embrace the why behind these plans can better serve patient cohorts. They can also improve their data collection through the use of comprehensive digital tools, providing a clearer picture of drug and device performance in the population as a whole.
Anju’s clinical intelligence solution TA Scan can help you comply with FDA’s Race and Ethnicity Diversity Plan with the help of its integrated diversity data. TA Scan allows you to visualize ethnicity, socio-economic data, and site / PI experience on a single map. You can also intuitively filter on age, gender, racial distribution, or average income. This saves you time and manual effort while ensuring a cohesive site selection and recruitment strategy. The diversity data is accessible in the TA Scan application or via our API. Recently, TA Scan and its integrated diversity data have won the SCOPE Best of Show award for most innovative technology used by clinical research professionals.
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