Overcoming Challenges Posed by Biomarker-Selective Clinical Trials: The Role of a Research Specialist

Project Summary/Abstract Molecular testing and targeted therapies have revolutionized cancer care resulting in better outcomes for patients. The number of biomarker-selective clinical trials continues to increase presenting challenges for cancer centers to adapt processes for efficient identification and enrollment of patients to these clinical trials. Furthermore, there is a gap in uptake of molecular testing and clinical trial enrollment for minority and underserved populations. Addressing these challenges plays an important role in ensuring equitable and effective care for all patients. The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center is an NCI- designated Comprehensive Cancer Center and one of eight with lead roles in both the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) and NCI National Clinical Trials Network (NCTN). Biomarker- selective studies are a major focus of these two networks. In this R50 Project, Dr. Gaillard will focus on addressing challenges in patient enrollment to biomarker-selective trials. The work will focus on three approaches: (i) development of a molecular registry to improve process of patient identification and determination of patient eligibility at the Center level, (ii) facilitate timely referrals to biomarker-selective trials using an electronic medical record clinical trials alert for eligible patients at the Physician level, and (iii) provide study-eligible patients with timely education on the role of biomarkers in treatment decision making (Patient level). The long term goal of this program is to develop a streamlined conduit for identifying, referring and enrolling patients for personalized medicine trials. Successful development will enhance accrual to NCI- sponsored clinical trials and be translatable to other cancer centers.