How to move from diversity to inclusion in medical research

Increasing racial diversity in clinical research is a common topic in the industry, and for good reason. The purpose of a clinical trial is to ensure that any new medications are safe and effective for the patient population, so it is of the utmost importance that studies have participant pools that reflect the diversity of real-world individuals.

Establishing the importance of this is the first step, but to create effective change, action must follow. In this blog, we’re examining the relationship between clinical trial enrollment and diversity, the importance of health literacy, and how sponsors can use these insights to inform their study design and outreach strategies.

Why is racial diversity in clinical trials so important? 

Historically, the clinical trial participant population has not been reflective of individuals in the real world. Statistics from a panel discussion at the BIO Conference in 2019 revealed that racial and ethnic minorities make up 39% of the population in the U.S., but comprise only 2% to 16% of clinical trial participants. Additionally, nearly 14% of Americans are Black and 19% are Latino. Still, these groups make up less than 5% and 1% of trial participants respectively.

While this lack of diversity is an issue from an inclusion standpoint, it can also be compromising from a scientific stance — a lack of diverse representation in clinical trials can make it particularly challenging to get a complete picture of a drug’s safety and efficacy. Because the current majority of clinical trial participants identify as white European men, minority individuals may be faced with reduced efficacy, increased safety risks, and unknown side effects if a research study is not adequately inclusive. 

The FDA guidelines for diversity in clinical trials

Once the importance of inclusion in medical research is established, the discussion can evolve to determine what actions can be taken to advance change. The FDA has guidelines for increasing the diversity of clinical trial populations, specifically focusing on patient-centric eligibility criteria, enrollment practices, and trial design guidance. Major themes include: 

• Making eligibility criteria less restrictive
• Ensuring trial participation is less burdensome for patients by reducing the frequency of study visits, using digital health technology tools, working with mobile medical professionals, and offering compensation for costs associated with participation
• Enrolling participants who reflect the characteristics of clinically relevant populations concerning age, sex, race, and ethnicity
• Including racial and ethnic minorities in clinical trials and the analysis of clinical trial data by race and ethnicity
• Providing resources in multiple languages

How to increase diversity and inclusion in medical research

Focusing on inclusive care and research participation makes healthcare providers and industry leaders responsible for designing and executing protocols that give all patients a seat at the table. So, what needs to be done? Below are several ways that sponsors and researchers can try to move the needle toward patient centricity to result in more inclusive trials:

Get the patients’ perspective. When designing study protocols, ask patients or caregivers what their opinions are. By working directly with patient communities, nonprofits, and advocacy organizations, it is possible to gain insights to address participant needs and design more inclusive protocols to reduce barriers to participation. 

Provide compensation where appropriate. Depending on the study design, the time commitment, effort, and travel requirements placed on participants can be difficult to juggle — especially for individuals more likely to work non-traditional hours, struggle with childcare, or have less flexibility in their schedules. Providing compensation, travel arrangements, and other monetary incentives can help recruit patients from diverse backgrounds.

Use imagery representative of patient populations. Performing successful outreach requires properly targeting the individuals the study is trying to reach and making sure that the outreach materials are likely to resonate. Imagery is often the first thing people notice about recruitment materials, so be sure that these are reflective of the ideal patient participant.

Ensure the copy is free from medical jargon. While calling out specifics such as the condition name and medication requirements may be helpful, ensure that the outreach copy is free from unnecessary jargon and complicated medical terms. Only about 12% of the country is considered “health literate” — this means that the majority of an audience may have trouble understanding health information. Patients are most likely to interact with studies that they understand, so writing outreach copy that’s easy to understand is an important element of accessibility.

Consider decentralizing parts of the trial. The COVID-19 pandemic provided us with a new framework for just how many things can be virtual, especially in the clinical trial space. Decentralized trials have become increasingly popular, and they can work well for both patients and sponsors. Trials that require less in-person interaction can allow researchers to cast a wider geographic net and can reduce costs through programs such as patient-reported outcomes and at-home lab visits.

The issue of diversity, equity, and inclusion in clinical trial participation is critically important, as better treatments and potential cures require trial populations to reflect the real world. Click the button below to learn how Antidote can help with your diversity-focused outreach efforts.