e13598 Publication Only Study design of a global molecular disease characterization initiative (MDCI) in oncology clinical trials. David Downs, Rob Weker, Melissa Lynne Johnson, Adrian G. Sacher, Marcus O. Butler, Hassane M. Zarour, Jeffrey S. Weber, Edward B. Garon, David Paul Carbone, Ann Dokus, Jessica Taylor, Arindam Dhar, Marilyn Metcalf, Cristina Messina, John Yonchuk, Kristin Blouch, Anne-Marie Martin; New Zealand Story, Auckland, AL, New Zealand; Weker Advisors LLC, Wynnewood, PA; Ten- nessee Oncology, Sarah Cannon Research Institute, Nashville, TN; University of Toronto, Toronto, ON, Canada; Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada; University of Pittsburgh Medical Center, Hillman Cancer Cen- ter, Pittsburgh, PA; Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY; Ronald Reagan UCLA Medical Center, Santa Monica, CA; The Ohio State University Wexner Medical Center, Columbus, OH; IQVIA, Durham, NC; GlaxoSmithKline, Collegeville, PA Background: Current clinical trial selection for patients with independent screening for each trial, re- sults in high screen failure and limited options for ineligible patients. MDCI’s concept for patient screening centers around broad molecular analysis and one screening protocol for multiple trials to in- crease patient inclusion and shorten recruitment time for oncology clinical trials.. Methods: MDCI was designed in collaboration with patients, physicians and study sites. Feedback from the Oncology Pa- tient Council (OPC) was solicited beginning at study conception with input on study design, the in- formed consent form and the Gather Share Know participant portal. Patients provided specific detailed feedback and user acceptance throughout development to ensure a truly patient-focused approach. To track implementation of feedback, the MDCI team developed a document, which was shared with OPC, recording all feedback received and all actions taken by the study team. Feedback from study sites led to additional flexibility for visits (ie, combining study visits 1 and 2; allowing for telehealth vis- its for visit 3) and collection of data on medical history and prior therapies to streamline the screening process. Physician input included the acceptance of next generation sequencing (NGS) to determine the best therapy for each patient. Results: The MDCI protocol combines analysis of patient medical his- tory, blood, and tumor assays, including HLA expression, protein analyses and NGS. A trial-matching approach, developed in collaboration with IQVIA, identifies potential clinical trials based on screening results. The Gather Share Know Hub, an optional patient-facing portal, allows patients to view the screening results identified as important for patients and information about ongoing clinical trial op- tions. Patients also have access to a patient-friendly informational video, disease-specific education, credible resources and information on “what to expect” at study visits. Physicians receive clinical re- ports and molecular profiles from multiple screening tests (available through the Physician Portal), en- abling them to make informed, data-driven decisions on the best clinical trial option for each patient. Conclusions: Utilizing a collaborative approach, MDCI was developed as a novel tumor-profiling proto- col. MDCI is designed to rapidly prescreen patients for multiple studies at once by evaluating each pa- tient’s tumor and blood genetics as well as their medical and cancer history using a prescreening algorithm. MDCI introduces an individualized approach to patient care with the aim of accelerating the availability of new therapeutic options. Continued feedback is solicited from patients on study design and the Gather Share Know hub through timed questionnaires to further enhance the patient experi- ence. This study (NCT04772053) is funded by GlaxoSmithKline (GSK). Clinical trial information: NCT04772053. Research Sponsor: GlaxoSmithKline. CARE DELIVERY AND REGULATORY POLICY © 2022 by American Society of Clinical Oncology. Visit abstracts.asco.org and search by abstract for disclosure information. Downloaded from ascopubs.org by 3.227.254.96 on July 1, 2022 from 003.227.254.096 Copyright © 2022 American Society of Clinical Oncology. All rights reserved.