Strategies for enhancing participation of underrepresented patient populations in cancer clinical trials: learning from “bright spots”

Abstract Background Adequate participation of women, older adults, racial and ethnic subgroups, and other groups, in pivotal trials for cancer therapies is critical for understanding and trusting the safety and efficacy of new medical products across populations. Despite consensus on the importance of representative research and extensive documentation of trial participation barriers, progress has been minimal for most groups, raising the question: What more can be done to enhance participation of underrepresented patient populations in cancer clinical trials, and in turn, improve medical evidence? Methods We used a “bright spot” approach to understand what drives successful representation of Black and LatinX patients in cancer clinical trials. We conducted 1-h interviews with “bright spot trial” teams, teams who conducted trials that adequately enrolled Black or LatinX patients relative to disease burden among pivotal trials supporting FDA approval of novel cancer therapeutics between 2012 and 2021, to identify organizational contexts and facilitators associated with success across multiple action levels. Transcripts were analyzed using constant comparative methods. Results Thirteen participants from 8 bright spot trial teams described a coherent set of strategies associated with representative enrollment, clustering across five levels: patient and community, clinician, trial and site, sponsor organization, and policy. Key practices included prospective budgeting for mitigating participant expenses; patient- and community co-developed educational programs; navigator use; early clinician engagement and referral training; protocol simplification, decentralization, and broadening of eligibility criteria; expansion into community and satellite hospitals affiliated with NCI Designated Cancer Center trial sites; and sustained, non-transactional community partnerships. At the organizational level, “bright spot trial” teams emphasized the importance of executive leadership commitment, real-time dashboarding on enrollment goals, performance-based incentives, employee training, and minimizing reliance on generic vendor solutions. Conclusions Sponsors that achieved representative enrollment in oncology trials shared a common operational playbook: reduce patient and site burden, expand access to where care is delivered, widen trial eligibility, invest in trusted relationships, and embed accountability through leadership, data and incentives. Translating these strategies from bright spots into standard practice, supported by clearer regulatory guidance and evaluation, offers a concrete path toward more accessible and generalizable cancer clinical research.