FDA Guidance for Diversity in Clinical Trials

Diversity in clinical trials is vital to ensure the safety and efficacy of new medical products and treatments. FDA suggests four recommendations to promote racial and ethnic diversity in clinical trials.
Clinical researcher talking to Hispanic participant in clinical trial

Diversity and Inclusion in Clinical Trials

Encouraging the participation of people from diverse backgrounds in clinical trials is essential for advancing health equity. The individuals involved in these trials must mirror the demographics of the patients who will ultimately use the medical products being tested.
Unfortunately, there’s often a lack of representation from racial and ethnic minorities as well as other diverse groups in clinical research. For instance, the FDA’s Center for Drug Evaluation and Research (CDER) approved 53 novel drugs in 2020. According to the 2020 Drug Trials Snapshots Report, of these associated trials, 75% of participants self-reported their race as White.
This lack of diversity is concerning because individuals of different ages, races, and ethnicities may respond differently to various medical products. Without improving representation in research, we can continue to expect:
  • Compromised generalizability of research findings to the broader population.
  • Lack of faith and trust in treatment options among vulnerable populations.
  • Hindered innovation.
  • Obscured safety or efficacy outcomes.
  • Uneven disease burdens.

What are Clinical Trials?

Clinical trials are research studies conducted on human volunteers to assess the safety and efficacy of a new medical product for patients. Prior to introducing any new medication to the U.S. market, sponsors are required to conduct clinical trials to ascertain whether it is safe and effective to use in the general U.S. population.

FDA’s Role in Clinical Trials

The Food and Drug Administration (FDA) supervises clinical trials for drugs, biologics, and medical products under its regulatory authority. These trials are crucial in the development of new drugs. When a sponsor aims to introduce a new medical treatment to the American public, they must provide the FDA with study designs and participant data from clinical trials for approval. The FDA reviews this information to determine if the new medication is safe and effective for broader usage among the general population, considering the intended purpose for which the drug is seeking approval.

Why is Participant Diversity Important for Clinical Trials?

When developing a new drug, researchers need to make certain that the population enrolled in the clinical trials represents the type of population that the drug is going to be used in.

An individual’s well-being is impacted by various elements, encompassing behavior, biology, surroundings, and notably, personal history. These life experiences are varied and influenced by factors like race, ethnicity, socioeconomic status (SES), location, gender, and other sociodemographic traits.

In order to acknowledge and accommodate these diverse life experiences, clinical research should include participation from racial and ethnic minority populations, along with other groups encountering health disparities. This approach aims to reduce biases, advance social justice, encourage scientific innovation, and ultimately attain health equity.

Real-World Example of Diversity in Clinical Trials

In the early stages of the pandemic, COVID-19 had a disproportionately heavy impact on several racial and ethnic minority communities, including African American, Hispanic/Latino, American Indian/Alaska Native, and Native Hawaiian and Pacific Islander groups. This led to higher rates of infection, hospitalizations, and fatalities within these populations.

It was vital to ensure adequate representation from diverse populations in COVID-19 vaccine trials to accurately assess their effectiveness, considering the varied environmental exposures and life experiences of individuals. By employing inclusive recruitment strategies, researchers were able to demonstrate that the safety and efficacy of vaccines remained consistent across all racial and ethnic groups. Moreover, engaging diverse populations enhances public trust in new medical interventions.

Barriers to Participation in Clinical Trials

Racial and ethnic minorities face numerous barriers that contribute to their reluctance to participate in clinical trials. These obstacles significantly impact health equity and the inclusion of diverse populations in medical research. Key factors include:

Eligibility Criteria

Using the same criteria across various trials can inadvertently lead to the exclusion of certain populations from trials, even when there isn’t a compelling clinical or scientific rationale for doing so. If individuals are excluded without sufficient justification, there’s a risk of overlooking critical safety and effectiveness insights about the new medication for all people who will take the drug, if it is approved by the FDA.

Mistrust in Clinical Trials

Historical mistreatment in medical research, such as the Tuskegee Syphilis study, have fostered deep-seated mistrust of public health officials and clinical trials, especially among many African Americans and Hispanic Americans. For example, the study was unethical because participants were not adequately informed about the nature of the study or the potential risks involved.

Pew Research Center conducted focus group discussions in July 2021, shedding light on the various factors that Black and Hispanic Americans consider when deciding whether to participate in a clinical trial.

I would [participate in a clinical trial], because I do suffer from migraines, so if there would be something for me to help other people who have migraines. I probably would.

Simultaneously, several participants talked about the delicate balance between their desire to help others and the need to safeguard themselves from potential harm.

Because basically, this is my body and I don’t really know what you’re testing on me. Anything can happen to me. I can just break down or probably anything can just happen to me. So I don’t want to take the risk. It’s unknown for me.

Lack of Awareness and Access

Minority individuals frequently lack awareness of clinical trials or encounter difficulties accessing information about them. This lack of awareness and accessibility hampers their ability to consider participation in these trials, potentially depriving them of opportunities for medical advancements. It is essential to address this issue to ensure equitable access to clinical trials and promote inclusivity in medical research participation among diverse populations. By improving awareness and accessibility, we can empower minority communities to make informed decisions about participating in clinical trials, leading to more representative and impactful research outcomes that benefit everyone.

Cultural and Language Barriers

Language differences and cultural nuances often create barriers to effective communication between researchers and minority participants in clinical trials. These obstacles can lead to misunderstandings and reluctance among minorities to participate in trials. It is crucial to address these challenges to foster trust, enhance communication, and promote greater inclusivity in medical research endeavors. By implementing strategies such as providing language interpretation services, culturally sensitive communication materials, and training researchers in cross-cultural communication, trials can bridge the communication gap and create a more inclusive and welcoming environment for minority participants. This not only improves the quality of research but also ensures that findings are applicable and beneficial to diverse populations.

FDA Guidelines to Improve Diversity in Clinical Trials

FDA published the guidance in April 2020 as part of its ongoing commitment to promoting the diversity of participants in clinical trials that test the safety and efficacy of new medical products. The guidance document provides recommendations that sponsors can apply to ensure participants in clinical trials are diverse.

  • Broaden the eligibility criteria for clinical trials and avoid unnecessary exclusions.
  • Design clinical trials in ways that achieve participant diversity.
  • Improve practices for recruiting participants to clinical trials.
  • Apply the recommendations for broad eligibility criteria to clinical trials of drugs intended to treat rare diseases or conditions.

Let’s dive deeper into each recommendation.

Broaden Eligibility Criteria

Clinical trials often establish stringent eligibility criteria, inadvertently leading to the exclusion of certain groups. Sponsors should carefully evaluate exclusion criteria to determine if any restrictions could be eased without compromising safety or scientific integrity. The FDA advises sponsors to include underrepresented racial and ethnic populations, such as Black, Asian, Hispanic, Native American, and Pacific Islander individuals, in trials to assess diverse responses to the new drug.

Sponsors are encouraged to set initial enrollment goals for underrepresented racial and ethnic groups, taking into account disease prevalence. Studying the drug’s effects in various populations enhances our understanding of its efficacy and safety, benefiting all individuals. By ensuring representation from diverse groups, clinical trials can yield more comprehensive and applicable results, ultimately advancing medical knowledge and improving healthcare outcomes for everyone.

Design Trials for Diversity

To ensure the enrollment of participants from diverse backgrounds, the FDA recommends several strategies for clinical trial sites. Firstly, sites should be situated in areas with higher concentrations of underrepresented racial and ethnic groups and indigenous populations, as well as in neighborhoods where these communities typically receive healthcare services. Additionally, sponsors should consider flexible visit times and reduce the frequency of in-person study visits whenever possible and appropriate.

One approach to facilitate participation is by arranging for mobile medical professionals, such as nurses and blood collection workers, to conduct home visits or by allowing participants to visit local clinics or labs instead of trial sites. Alternatively, sponsors can employ electronic options, such as contacting participants via phone, email, social media, or telehealth technologies, to collect data and minimize the need for in-person visits.

Furthermore, it’s crucial to consider cultural nuances that may impact participation and commitment. Cultural awareness plays a vital role in engaging diverse groups in clinical trials. Practical steps to attract and retain underrepresented racial and ethnic participants involve tailored approaches such as providing language support, accommodations for individuals with disabilities, and addressing transportation barriers.

Here are five steps you can take to facilitate limited English proficient (LEP) patient recruitment to represent more diverse populations.

Improve Recruitment Practices

The FDA advises sponsors to ensure that interested individuals are well-informed about the trial and understand what participation entails. Recognizing that not all participants may be fluent in English, sponsors should provide trial-related resources and information in multiple languages, along with interpreters for those with limited English proficiency. Seeking feedback from participants or potential participants can also offer valuable insights into their challenges, burdens, and risk tolerance.

Engagement with the community is crucial. Sponsors should consult with patients, focus groups, community advisory boards, medical societies, healthcare providers, and disease registry staff to understand potential participants’ needs. Holding events in trusted locations such as places of worship, community centers, or cultural festivals can facilitate outreach.

Sponsors need to maintain ongoing engagement with participants and their communities even after the trial concludes. Sharing updates about the clinical trial helps to sustain and strengthen relationships with the communities from which participants were recruited.

Utilizing social media platforms is another effective strategy. For instance, if traditional referral centers are inaccessible to some participants due to location constraints, sponsors can employ online and social media recruitment methods to reach potential participants more effectively.

Diversity Clinical Trials for Rare Diseases

A rare disease is defined as a disease or condition that affects fewer than 200,000 people in the United States. Due to their low prevalence, studying and finding treatments for these diseases pose significant challenges. Sponsors conducting clinical trials for rare diseases must make special efforts to ensure diversity among participants.

During the early stages of medication development, sponsors can engage with patient advocacy groups, rare disease experts, and individuals living with rare diseases to solicit their input on trial designs, procedures, and other aspects. By incorporating patient suggestions, sponsors can enhance the relevance and effectiveness of clinical trials. This collaborative approach fosters trust and encourages patients to enroll in and support the trials, knowing that their perspectives are valued and considered. Ultimately, these efforts contribute to advancing research and improving outcomes for individuals with rare diseases.

PGLS as Language Service Partner in Clinical Trials

The necessity for meaningful representation of racial and ethnic minorities in clinical trials is apparent in the FDA’s dedication to health equity. This importance is further emphasized by the adverse effects on patient outcomes and the general applicability of trial findings when diverse populations are excluded.

Addressing these challenges isn’t just about ethical and fair practices; it holds tangible implications. Enhancing diversity and inclusion in clinical trials can lead to more precise data and diminish disparities in health outcomes, ultimately benefiting society as a whole.

PGLS offers high-quality translation services in over 200 languages, ensuring excellent experiences for Limited English Proficient (LEP) patients in clinical trials. Our highly qualified pool of linguists can facilitate sensitive patient interactions with both empathy and accuracy. We are dedicated to assisting you in navigating the intricacies of FDA and HIPAA requirements, utilizing our trusted in-country linguists, subject-matter experts, board-certified medical doctors, and sophisticated translation software to bridge language and culture for compassionate and effective communication. Get in touch to learn more.