Diverse participant pools in clinical trials lead to better health outcomes for everyone. By promoting diversity in clinical trials, we ensure that medical treatments and interventions are safe and effective for everyone, regardless of their background or identity. Unfortunately, clinical trials have historically failed to achieve adequate representation of minority groups. Lack of representation in a clinical trial can lead to biased and incomplete data and potential harm to these underrepresented groups. Improving diversity and equitable access to clinical trials has been a slow process, but growing industry awareness of the issue, motivation to right past wrongs, and new legislation aimed at this lack of inclusion are changing the tide.
While improving diversity in clinical trials is critically important, it is not simple. Achieving an equitable and diverse clinical trial requires careful planning, monitoring, and creative, dynamic thinking. Not sure where to start? Here are some specific actions that sponsors can take, including how Curavit can help you improve the recruitment and retention of diverse clinical trial participants:
• Implement a diversity plan: As of 2022, certain clinical trials are now required by law to submit a diversity action plan to the Food and Drug Administration (FDA). Using FDA guidelines, Curavit can develop a specific plan for promoting diversity in your trials. The plan will be based on a thorough analysis of the demographics of the target population and the barriers to participation that may exist. This plan will include recruitment goals, strategies, and metrics for measuring success.
• Facilitate participation with the study design: Study design should be optimized to encourage diverse populations to participate. This can include selecting study sites in diverse communities, using multiple different recruitment methods, and ensuring that the targeted study population is representative of the population where the treatment will ultimately be used. Decentralized clinical trials (DCTs) are uniquely useful for reaching a wide range of potential participants. DCTs can overcome some traditional barriers to entry by eliminating the need to travel to a study site that is far from home. Leveraging Curavit’s DCT expertise and collaboration with our partners who specialize in diverse patient recruitment will ensure that your recruitment strategy is set up for success.
• Engage with diverse communities: Clinical trial sponsors should strive to connect with diverse communities through partnerships with community organizations, leaders, and community medical providers. This can help build familiarity, trust, and understanding between the study team and potential participants. Curavit can help connect you with the right individuals and organizations to support your community engagement efforts.
• Address cultural and linguistic barriers: Study planning should involve anticipation and preparation to overcome any potential cultural and linguistic barriers to participation. This can include translating study materials into different languages, using culturally appropriate messaging, and providing interpretation services during study visits. Curavit is poised to help you identify the linguistic and cultural consultation services you might require and to connect with the best partners to get the job done.
• Monitor diversity: Clinical trial sponsors should be aware of the changing demographics of the study participant pool throughout the course of the study and be prepared to take steps to address any gaps in representation. This can include targeted outreach efforts to underrepresented groups. This also involves tracking attrition rates and working to eliminate stress points that might be causing participants to discontinue their involvement with the trial. Curavit can work with your trial sites to track and report participant metrics in a convenient and easy-to-digest format that gives you peace of mind that the study participants are truly representative of the population you are hoping to reach.
• Foster diversity in research teams: Clinical trial sponsors should foster diversity within their research teams. This can include recruiting and promoting researchers from diverse backgrounds, providing training and support for researchers to better understand and work with diverse communities, and ensuring that study teams reflect the diversity of the population being studied. Some studies have even shown lower attrition rates of minority participants when the study teams are from familiar and similar cultural backgrounds. By promoting diversity, equity, and inclusion within our own company, Curavit strives to bring unique perspectives and cultural competencies to each of our study sponsors’ projects.
As the landscape around diversity in clinical trials changes for the better, it is critical for study sponsors to stay abreast of current best practices and strategies. Curavit is proud to provide comprehensive diversity, equity, and inclusion consultation services tailored to help our clients bring historically underrepresented groups to the clinical trial table— to create a more equitable and just healthcare system for all.