Increasing Access and Participation to Early Phase Clinical Trials to the Underrepresented Populations

Project Summary Access to health care including clinical trials leading to paradigm-changing cancer treatments is critical for high quality cancer care and equity in society. Differences in risks and cancer biology may contribute to disparities in cancer outcome particularly if minority/underserved groups are underrepresented in clinical trials as impact of

newer cancer therapies may not be adequately evaluated in these populations. Compared to later phase clinical trials, early phase trials are more complicated but are pivotal in the development of novel and more effective therapies. Participation into early phase clinical trials is often the only way a patient can access potentially

effective novel therapies not yet available commercially. There is evidence of direct medical benefit, improvement of quality of life, and achievement of psychological benefit in early phase trials. The challenge of engaging minority/underserved populations is more profound in early phase clinical trials as they are generally more

complex and often accessible only in larger centers in the metropolitan areas. In this project, Dr. Baranda will continue to lead in the development of sustainable and intentional strategies to extend access and increase participation to early phase Experimental Therapeutics Clinical Trials Network (ETCTN) clinical trials to underrepresented populations including the veterans using a roadmap built from

lessons learned from the National Cancer Institute’s (NCI) CATCH-UP.2020 (Create Access to Targeted Cancer Therapy for Underserved Populations) program. Implementation of more rigorous analysis of areas of unmet needs, efficiency in ETCTN clinical trial for timely activation, trial selection and prioritization, and engagement of

physicians throughout our catchment area will continue to be adopted in this project. A project for efficient workflow in genomic characterization of patient tumors will allow identification of patients appropriate for biomarker-driven ETCTN precision medicine clinical trials. KUCC will lead the Equity-Focused Clinical

Investigators Team within the ETCTN UM1 consortium through exchange of novel approaches among ETCTN sites and ensuring the use of pragmatic approach in clinical trial design to prevent unnecessary burden to pts and minimize load to the clinical trials operations in ETCTN.