Best Practices for Addressing Diversity in Clinical Trials

Why Diversity in Clinical Trials is Crucial 

FDA requires safety and efficacy data from clinical trials in order to approve prescription drugs and other treatments. This clinical data provides insights into how prescribers will respond to medicines and how medicines may be best used.

But differences between individuals, including age, genetics, gender, weight, ethnic origin, and geographic location generally lead to different responses to the same mediation. 

For example, Black people or African Americans may need an entirely different dosage or drug altogether for certain conditions compared to White, Asian, or Hispanic individuals. 

Statistics from the US Census Bureau revealed that racial and ethnic minorities make up 39 percent of the population in the US. 

Additionally, a 2014 study in Clinical Pharmacology & Therapeutics found variations in how people from different ethnic groups reacted to nearly 20 percent of new drugs approved between 2008 and 2013.

Therefore, diversity in clinical trials is crucial to public health and the overall well-being of individuals. 

Federal agencies have recognized the different characteristics that can impact drug safety and effectiveness. So in 1993, the National Institutes of Health (NIH) adopted a policy, called the Revitalization Act, which ordered all federal grants for clinical research to include women and minorities. 

Then in 2000, the NIH updated the policy for the inclusion of women and minority groups in clinical trials. The updates required inclusion of women and members of minority groups in all “biomedical and behavioral research projects involving human subjects.” 

FDA has also released policies to better understand the barriers for a more diverse population. 

But despite these early efforts, current clinical diversity is still severely lacking. 

Challenges of Clinical Trial Diversity

A February 2021 JAMA Network Open study has revealed that diversity in clinical trials is still lacking.

Data from completed interventional vaccine trials from July 2011 to June 2020 showed that White individuals were overrepresented (77.9 percent of the time) in clinical trials, while Black or African American individuals were represented only 10.6 percent of the time and Hispanic or Latino participants were represented just 11.6 percent of the time. 

Asian individuals and American Indian or Alaska Native individuals were represented the least amount in the trials, at just 5.7 percent and 0.4 percent, respectively. 

“Among adult participants in US vaccine clinical trials, the racial/ethnic minority groups that we studied and people 65 years or older were underrepresented, whereas female adults were overrepresented. Populations with an increased infectious disease burden should be equitably included in trials of vaccines for COVID-19 and other vaccines,” researchers stated.  

Clinical trial sponsors and researchers just haven’t gotten there yet, with many citing key barriers to improving diversity.

According to Hopkins Biotech Network, there are a few major barriers that lead to the lack of diversity in clinical trial recruitment. 

First, a majority of providers do not have a robust patient engagement plan. Doctors may not have enough time to teach patients about clinical trials during one appointment or may feel uncomfortable answering the patient’s questions about specific details of the trial.

Second, the continuing need for medicine in the pharmaceutical industry has led to many expedited pathways for approval. Therefore, clinical trial diversity may not be a priority. 

Finally, certain groups of patients may be wary about participation for many different reasons, such as economic, linguistic, cultural, religious, or even physical barriers, including lack of access to a health center. 

An individual’s inability to cover treatments that are part of a trial or lack of health insurance are also main factors leading to the shortage of trial diversity. 

Additionally, minorities are generally more likely to have health issues, such as high blood pressure, diabetes, and heart disease. Due to increasingly rigorous trial inclusion criteria, having these conditions often eliminates these individuals from participating in trials. 

How to Improve Clinical Trial Diversity

Major organizations, including PhRMA and FDA, have released and updated policies to improve diversity in clinical trials. 

In 2017, for example, FDA updated the Revitalization Act to require investigators to not only include specified groups in NIH-defined Phase 3 clinical trials, but also submit their results to ClinicalTrials.gov after conducting analyses based on sex, gender, and race or ethnicity. 

In November 2020, the agency also issued final guidance to encourage clinical trial diversity from the design to execution of the tests.

The guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, addresses both demographic characteristics of study populations, including sex, race, ethnicity, age, and location of residency, as well as non-demographic characteristics, such as comorbid conditions or disabilities.

At the same time, PhRMA announced the release of industry-wide principles on clinical trial diversity that will focus on four main areas. 

The first two principles will focus on building trust and acknowledging the historic mistrust of clinical trials within Black and Brown communities as well as reducing barriers to clinical trial access. 

To put these two principles into action, PhRMA states that improving community outreach and health literacy can build trust and increase clinical trial awareness, which can directly help address recruitment, enrollment, and retention of a diverse clinical trial population.

Additionally, the strategy can expand access to investigational treatments for underserved populations.

“We commit to conduct outreach to the medical community in communities that have been underserved and support trial sites with comprehensive education on medical product development,” the organization said. “We will do so in a manner that is culturally competent and developed in partnership with the communities we are seeking to serve.” 

The third and fourth principles focus on using real-world data to enhance product information, as well as boost information regarding diversity and inclusion in clinical trial participation. 

PhRMA said that biopharmaceutical companies should use information on populations at risk for a particular disease, data from earlier trials, the therapy’s mechanism of action, or any real-world evidence to enhance understanding of a certain treatment’s effect for selected subgroups.

Additionally, collecting real-world evidence may be an important method of supplementing trial data and could serve as an effective way to enhance understanding of drug effects in diverse patient populations. 

“Biopharmaceutical companies that voluntarily adopt these principles should establish or maintain policies or practices that focus on enhancing the diversity of clinical trial populations and promoting enrollment practices that lead to clinical trials better reflecting all populations who are likely to use the medical product once it is approved,” PhRMA said. 

In light of renewed focus on diversity in clinical trials, pharmaceutical company Pfizer also recently released recommendations to increase diversity.

One of the recommendations was that patients would benefit from more education on clinical trials, including outreach and education programs in churches, schools, town hall meetings, and community centers. This may help to bring better awareness of clinical trials to all communities.

Additionally, doctors could talk to their patients about clinical trials and may also look into becoming trial investigators themselves.

The COVID-19 pandemic has brought to light the longstanding racial and ethnic disparities in clinical trials. Therefore, it is likely that top pharmaceutical companies will release their own recommendations and put principles into action to increase diversity in the future.