Key Takeaways and Learnings:
Fostering inclusion effectively is a longstanding challenge in clinical trials. Clinical research recruitment strategies have evolved to reach out to a wider range of population segments, through steps such as highly targeted advertising or careful site selection. However, these actions alone aren’t enough to overcome systemic barriers to clinical trial access — ranging from structural health inequities to limited access to the research process.
The impact of inequity is most acutely felt in communities of color. Given ancestral differences, potential variances in how drugs are metabolized, and preconditions that may be present in communities of color, less is known about the safety and effectiveness of therapeutics in these populations compared to White individuals who are overrepresented in drug trials.
Clinical research recruiters face competitive pressures and federal regulatory guidance to make trials more inclusive. Getting this right requires a more holistic approach that addresses root causes of inequity by building trust within communities of color before recruitment begins by using solutions such as Acclinate’s NOWINCLUDED community and the e-DICT insights platform.
Driven by congressional action, the U.S. Food and Drug Administration is pushing sponsors to submit Diversity Action Plans for major trials. The FDA wants to see these plans prior to the start of Phase 3 studies, ideally as early as possible. The goal is to ensure clinical research recruitment strategies consider multiple dimensions of diversity poised to impact a trial’s outcomes from the very beginning, rather than viewing diversity as an afterthought.
Diversity Action Plans are necessary because the challenges affecting participation in clinical trials, particularly among communities of color, are well-documented. Factors include limited knowledge of the medical system and clinical research process, historical atrocities, implicit bias from healthcare providers and researchers, language barriers, cost of participation, time commitments, and a lack of transportation to faraway trial sites.
The biggest barrier to trial participation is distrust. Individuals who otherwise meet a trial’s inclusion criteria as well as a sponsor’s desired demographic profile are unlikely to enroll if they don’t trust their primary care physicians, trial sponsors, or clinical research recruitment agencies working with these entities.
Distrust of the medical industry in communities of color is deep and systemic. It cannot be overcome with free parking or better brochures. Nor can trial sponsors rely on cognitive trust alone, or trust based on logic and reasoning, to build rapport with communities of color.
Successful clinical research recruitment strategies emphasize affective trust, which is based on emotional connections and shared values. This approach is all about providing transparent communication about what a trial hopes to accomplish, along with building genuine relationships with community leaders and organizations already familiar to potential participants.
The American Society of Clinical Oncology (ASCO) and Association of Community Cancer Centers (ACCC) recently offered recommendations for increasing diversity in clinical trials that align with the affective trust approach. Suggestions from ASCO and ACCC included screening more eligible patients in clinical settings, broadening the selection of physical trial sites, and offering ongoing training to research teams in topics of inclusion, such as culturally sensitive communication methods.
Using community platforms such as Acclinate’s NOWINCLUDED, clinical research recruitment agencies can connect individuals in communities of color to resources about their health and encourage greater in-person and virtual participation in wellness and clinical care. Acclinate’s AI-powered predictive analytics solution e-DICT can identify individuals with a high likelihood of trial participation and track their engagement with trial sponsors, helping to ensure messaging reaches the right individuals at the right moment.
By forging ties with communities of color and providing relevant education and support, clinical research recruiters are positioned to build affective trust and break down traditional barriers to clinical trial participation. The five key benefits of this approach to clinical research recruitment strategies include:
Establish more inclusive clinical research by genuinely connecting with marginalized communities and refining outdated recruitment practices. Acclinate engages and mobilizes communities of color with its community platform, NOWINCLUDED, while leveraging its AI-powered analytics interface, e-DICT, to monitor participation. To find out more, schedule a 1:1 meeting with our team.