Enhancing diversity in oncology trials: Key strategies from the ACORI community oncology inclusive clinical trial design summit.

Background: Oncology clinical trials often lack ethnic and regional diversity, limiting the generalizability of findings across real-world patient populations. The Association of Cancer Care Centers (ACCC) Community Oncology Research Institute (ACORI) hosted the ACORI Community Oncology Inclusive Clinical Trial Design Summit on October 29–30, 2024 to convene multidisciplinary stakeholders to identify and address barriers to participation among underrepresented groups in clinical trials in the community settings. Methods: The summit featured didactic sessions, case-based presentations, and moderated interactive discussions with 76 participants, including 24 cancer center practitioners and researchers, 17 professional and patient advocacy organizations, industry representatives, and leaders from the FDA, NCORP, and the National Cancer Institute. The summit focused on identifying actionable solutions to expand access to clinical trials by enhancing clinical trial design, employing innovative operational delivery of trial opportunities, and building consensus on effective strategies around engagement, recruitment, and retention of participants and communities. Results: Discussions yielded the following recommendations to increase trial diversity: Strengthening the clinical trial workforce: Expand APP and clinical pharmacist roles as principal investigators through education and advocacy and strengthen training pathways for trial navigators/coordinators. Optimizing trial design and infrastructure for diverse populations: Broaden eligibility criteria, simplify protocols, and incorporate patient-friendly tools like e-consent and multilingual resources. Fostering community engagement: Build trust through local partnerships, establish patient education programs, and address systemic biases in trial recruitment. Advancing Decentralized Clinical Trials (DCTs): Advocate for flexible regulatory frameworks, educate practitioners through a DCT implementation playbook, and utilize community-based healthcare infrastructure. Leveraging AI and digital tools for trial efficiency: Apply AI for patient matching, protocol simplification, and remote monitoring, while improving transparency and interoperability with EHRs. Conclusions: Inclusive trial design and delivery of trial opportunities are essential to achieving equitable cancer care. Addressing systemic barriers and adopting innovative approaches can enhance diversity and improve the generalizability of clinical research. Through ACORI, ACCC will continue to foster collaboration among stakeholders. This remains critical to ensuring sustainable progress in community oncology research.