Disparities between patients included in oncology clinical trials and real-world patient populations continue to exist, and often jeopardize the generalizability of the results. The gap between study populations and the targeted cancer population has become a high-priority public health problem. There have been numerous initiatives across large US oncology organizations aimed at reducing disparities and increasing diversity in clinical trials at regional and national levels. One example is the US Food and Drug Administration Oncology Center of Excellence launch of Project Equity and issuance of draft guidance for industry to support greater diversity in trial populations. The National Cancer Institute is exploring program-based, investigator-based, and patient-based strategies to increase access and accrual to oncology clinical trials.
Dr Ana Acuña-Villaorduña and colleagues reviewed several projects by these and other organizations to summarize best practices for increasing access of underserved populations to clinical trials. Best practices to support greater diversity in clinical trial populations include broadened eligibility requirements for trials, simplification of trial procedures (eg, telehealth, fewer study visits), community outreach through patient navigators, decentralization of clinical trial procedures to community settings, and funding to offset costs of travel and lodging. In addition to clinical considerations, operational measures and strategies can foster engagement and collaboration with key stakeholders, such as global regulatory authorities and community cancer centers.
Implementation of policies that improve access to clinical trials is critical for improving care of historically underserved and under-represented populations. To achieve greater diversity and equity, major long-term cultural shifts in the educational and professional practice, research, and regulatory communities are needed. This will require clear communication and interaction between all stakeholders, as well as major increases in funding.
Cultural changes are also needed at the practice level. Local efforts can help to incentivize patients and improve access to clinical trials among underserved and under-represented populations. Community outreach is most effective when facilitated by cultural and linguistically appropriate advocacy groups, patient navigators, and study coordinators.