Three key ways to drive diversity in clinical trials
People of color are largely unrepresented in clinical research studies. However, many factors, including biological sex, disabilities, chronic comorbidities, geographical location, gender identity, race, and ethnic background, can influence how an individual may react to certain drugs, medical devices, and treatment plans. We share three key ways to drive diversity in clinical trials, so that communities of color and diverse populations are better represented in your studies.
Get input on protocol design from communities of color early in the process
Communities of color should be involved in all aspects of a clinical trial, including protocol design. Diverse communities are able to ensure that a trial addresses real patient needs, and that inclusion and exclusion criteria balance scientific requirements with the real-world experiences of patients. Individual advocates, advocacy groups/networks, and health nonprofits are great choices for input on study design.
Allison Kalloo of Clinical Ambassador told us: “Another barrier falls under study design, and for Black and Brown people who wrestle with social determinants of health, having comorbidities, or pre-existing conditions, summarily excludes these individuals from participation at the gate.” That’s why input from a diverse community of patients is critical. It helps identify elements of a trial that appeal most to them, their symptoms, and their health history. This also becomes valuable information when it comes time to develop outreach materials.
Working with a recruitment company that has relationships with a vast network of diverse patient advocacy groups can help sponsors access input from these organizations.
Include diverse messaging and imagery across all outreach venues
All clinical trial recruitment campaigns should start with a strategy, which must include communities of color from the start. In your planning, it’s important to make sure that you’re providing adequate resources to communities of color for the duration of a recruitment campaign.
Outreach materials should visually reflect the diversity of your patient population. Involving communities of color in the process of creating recruitment strategies and materials is an important step in making sure campaigns resonate with diverse audiences. Patients are more likely to connect with imagery that reflects who they are and what matters to them. Successful campaigns and effective advertising must mirror the real-world patient population in their imagery, copy, and targeting.
Additionally, recruitment materials should incorporate feedback from patients themselves as well as echo the sentiments that patients are sharing amongst themselves. Before submitting recruitment materials to an Institutional Review Board (IRB), partner with patient advocacy groups and individuals to review the materials to ensure they will resonate with that patient population.
There are some important questions you should be asking yourself, such as: What are patients talking about online when they’re not at a site or a doctor’s office? Learning about your target patient communities when they’re not in a medical setting is necessary to understand a greater picture of their lives. Engage with Instagram hashtags, watch community TikTok videos, and read posts in Facebook groups to learn important things about patients, such as attitudes toward clinical research and recruitment, what treatment regimens individuals are using, and symptom management.
If you’re planning on working with a patient recruitment company, ask to see examples of their outreach materials from prior campaigns, preferably from the same condition area. Did their images match the demographics of their target audience? Did they include a variety of options that spoke to a range of patient experiences? What kinds of communities of color did they partner with to successfully launch the campaign?
Be flexible and offer fair compensation
Also critical to maintaining diversity is ensuring that clinical trial sites are geographically accessible to all – not just those near an urban center. Key prohibitive barriers to participation can be the location or distance to trial sites, limited transportation, work, caregiving constraints, and sometimes a lack of access to technology, especially for decentralized trials that require data input and monitoring.
The important message here is to allow patients flexibility. If an individual wants to participate in your study and help accelerate the research behind groundbreaking treatments, make sure they have what they need to take part, whether that is time, technology, money, or ride-share services to your site.
Flexibility is necessary, and so is compensating study participants well. It’s important to point out why participants are being compensated in the first place: individuals are engaging in a potentially risky endeavor. Access to care and facilities that aren’t available to average patients are great perks, but the treatments being tested often times have not been approved. That, coupled with the intense time constraints that many clinical trials require, is a major reason that clinical trials should pay their participants well.
According to experts, in consideration of both the ethics and the logistics of payment to research participants, payment should be partitioned into three categories: (1) reimbursement for expenses incurred as a result of participation, (2) compensation for time and effort related to research participation, and (3) incentive payments to encourage participation, retention, and study completion. At the end of the day, participants should not be further economically disadvantaged by agreeing to volunteer in clinical research.
Looking for patient recruitment support? Antidote uses precision recruitment to reach the right patients with the right messaging, working with communities of color and patient advocates along the way. Get in touch to learn more about our unique approach to clinical trial patient recruitment.