Disparities in clinical research are well-documented, and part of the broader health care disparities we see as a byproduct of systemic and institutional racism. COVID-19 vaccine and treatment development has greatly amplified the need for all communities to have the same opportunity to participate in research. Lack of representation of minorities in lung cancer clinical trials have been reported over the past 20 years. We have previously reported that there is a disconnect between U.S. lung cancer clinical trials placement and where patients with lung cancer reside, especially racial minorities. Both NCCN and ASCO guidelines suggest that clinical trials be considered the standard-of-care for advanced-stage non-small cell lung cancer and extensive-stage small cell lung cancer patients in first- and subsequent- line settings. In addition, participation in clinical trials has been associated with improved overall survival in lung cancer regardless of cancer stage, insurance and other prognostic factors. In order to provide better outcomes and achieve health equity for historically underserved populations, we must work together with all stakeholders to increase representation of diverse populations in lung cancer research. Our Question: What is a successful and sustainable multi-stakeholder framework that will result in inclusive lung cancer research in the US? Our methods will expand on previous work in the identification of notable practices where the focus was on successful pan-cancer inclusive clinical trial practices in 8 US cancer centers. We will include notable practices and recommendations of all stakeholders and focus on successful lung cancer inclusive research practices including behavioral research, community-based research and clinical research. We will conduct a robust environmental scan to identify strategies and standards, process and capabilities and roles. We will specifically identify tools and references to engage patients with lung cancer where applicable and interview identified experts based on practice themes representing all key stakeholder groups. Authors have identified 14 preliminary practice themes representing all key stakeholder groups to guide our framework development: Leadership & Goals; Protocol development; Operations and process; Data collection standards and reporting; Site selection, Health literacy & translation of recruitment materials including informed consent; Bilingual research staff; Community & Patient Engagement; PCP engagement; Digital capablities, Budget elements; Employee engagement and training; IRB Approval; Investigator meeting standards. Our framework is intended deliver the foundation for a theoretical underpinning of a evidenced based practical guide toward fostering collaboration amongst and between health care systems, academia, industry, health care leaders, PCPs, and patient organizations to promote successful inclusive research practices in lung cancer and will provide a roadmap for other disease areas.
Citation Format: Jeanne M. Regnante, Narjust Duma, Quita Highsmith, David E. Gerber, Lorna McNeill, Upal Basu Roy, Gerren Wilson, Mary Stober Murray, Andrea A. Ferris, Fabian Sandoval, Moon S. Chen, Jr. A guide for development of a successful and inclusive lung cancer research strategy based on U.S. best practices [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-096.