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A lack of diversity in clinical trials is a critical issue, as racial and ethnic subgroups may respond differently to therapies, potentially undermining efficacy and safety outcomes and producing results that are not representative of the patients who will receive the treatment in the real world. Furthermore, clinical trials provide access to novel therapies, making participation in clinical research an issue of health equity.

Many factors have made it challenging for biopharmaceutical and medical device companies (sponsors) and Contract Research Organizations (CROs) to achieve clinical trial diversity. New regulatory guidance, such as the Consolidated Appropriations Act of 2023 requiring diversity action plans for pivotal trials including Phase 3 trials, has made it increasingly imperative to enact practices ensuring diversity in clinical studies.

There are several key areas upon which sponsors and CROs can focus to implement diversity strategies that achieve inclusion representative of the overall patient population.

Optimize site selection to speed trials and enroll diverse patients. To ensure a diverse trial, it is critical that sponsors and CROs build diversity into the study planning and site identification process. Historical clinical trial data, alongside epidemiology data, can provide a baseline for informing both the diversity goals and the rationale behind those goals, as mandated by the diversity action plans.

Site identification can help achieve diverse enrollment by assessing a site’s performance not only from an operational perspective (e.g., enrollment rate, data quality) but also from diversity performance. Identifying the right sites early on can increase the likelihood of working with high quality, fast enrolling sites that can also ensure diverse representation.

Additionally, working with sites that are trained in decentralized technologies and have access to a diverse patient population increases the ability to educate and provide access to underserved communities. Integrated research organizations such as Circuit Clinical offer a comprehensive DCT-enabled site network for increasing accessibility to underrepresented groups.

Engage trusted community partners to develop the trial strategy. As patients are the true experts in their own patient journeys, infusing their voices into protocol design is crucial to enhancing the trial experience and building trust.

Gathering a diverse group of patient advocates or working with a partner offering an established program that enables patients to share their insights on trial design, schedules of events, and appropriate measures for supporting diverse groups can provide the guidance needed to foster an optimized trial experience.

Foster continuous patient engagement to address disparities in access and awareness. As clinical trials have shifted from a transactional experience to a more engaging approach that deepens relationships among patients, sites, and sponsors, the industry has developed aligned solutions embracing patient education, engagement, and empowerment throughout the trial lifecycle. Pre-trial, sponsors can engage patients through patient registries to prepare them for research participation offering access to essential, easily digestible trial information, pre-screening, and trial matching capabilities. Post-trial, patients may view their clinical trial data and receive updates about future trial opportunities.

Shifting the trial approach towards continuous patient engagement can help to build a pool of diverse, confident, and research-ready participants while addressing disparities in clinical trial access and awareness while providing an engaging pre- and post-trial experience.

Summary
Improving diversity by developing meaningful action plans is critical for true clinical trial success and regulatory compliance. While there is no simple solution to solving complex diversity challenges, a multi-faceted approach can help develop a solution that best fits the needs of the patient population being served.

Working with a trusted partner such as Medidata to leverage its Diversity Program can assist in building diversity strategies that improve access, raise awareness, and foster inclusion, creating a trial experience where patients are valued.