Improving Health Care Outcomes Through Increased Clinical Trial Diversity: Embracing a…

Health disparities continue to be a significant challenge in the healthcare industry, particularly with respect to race and ethnicity. One crucial aspect contributing to this issue is the lack of diversity in the recruitment and retention of underrepresented patients in clinical trials. Clinical trial diversity plays a pivotal role in ensuring that medications are safe and effective for all intended treatment populations. However, as of a 2020 FDA report, three-quarters of clinical trial participants for novel drugs were white, while underrepresented populations, including Hispanic, Black or African American, and Asian participants, were significantly underrepresented.

Recognizing the urgency to address this disparity, the FDA published updated guidance in 2022, emphasizing the need to enhance the diversity of clinical trial populations. In 2023, this guidance was solidified into law through the omnibus spending bill, making it a requirement for FDA-approved drug safety and efficacy studies to include a clinical trial diversity strategic action plan. This move aims to promote inclusive research and eliminate costly delays that arise when trials fail to engage representative patient populations.

The life sciences industry has a responsibility to commit to change collectively. Acknowledging the existing inequities and committing to a community-based approach is essential to improve clinical trial diversity and, subsequently, health care outcomes for all patients. Patient perspectives and experiences are invaluable in shaping strategies to encourage more diverse participation in clinical trials. As such, the industry must listen to patients and learn from them to develop more inclusive and effective trial recruitment and retention strategies.

Key considerations in fostering clinical trial diversity revolve around implementing a multifaceted community-based approach. The approach encompasses various stages of the clinical trial life cycle and ensures ongoing patient engagement.

1. Pre-clinical trial: Increasing patient knowledge and awareness of clinical trials in underserved communities is crucial. Patients from underrepresented populations often lack awareness of clinical trials, which underscores the need for targeted educational efforts and outreach programs. Establishing trusted messenger programs, involving community leaders, and utilizing social media can help bridge this gap.
2. During clinical trial: Enhancing patient access and convenience are vital factors in attracting diverse participants. Patients of color reported not being asked to enroll in clinical trials as frequently as white patients. Reducing barriers, addressing safety concerns, and alleviating the financial burden of participation are actionable steps to improve diversity.
3. Post-clinical trial: Maintaining community relationships through ongoing engagement is key to sustained diversity. Collecting post-trial feedback, conducting awareness events, and providing continuing education programs for investigators and site staff help strengthen the bond between communities and the industry.

While progress has been made, there is still much work to be done to ensure diverse representation in clinical trials. Organizations must prioritize diversity, equity, and inclusion (DEI) and center their strategies on community needs. Novel and sustainable approaches, driven by community-based efforts, can create a win-win-win situation for patients, sponsors, and the overall healthcare ecosystem. Patients gain equitable access to life-saving therapies, sponsors collect more representative data, and the healthcare ecosystem experiences improved patient outcomes and sustained community engagement.

In conclusion, fostering clinical trial diversity through a community-based approach is not only a moral imperative but also a crucial step towards achieving equitable and effective healthcare outcomes for all patients. By actively listening to patients and learning from their experiences, the life sciences industry can create a more inclusive and impactful future for clinical research and healthcare as a whole.