Abstract B007: A qualitative research study on hematology and oncology consultants’ experiences and opinions on using minimal residual disease (MRD) as a fast-track approval endpoint in early-phase clinical trials in multiple myeloma in Saudi Arabia

Abstract Introduction: The U.S. Food and Drug Administration recently considered the minimal residual disease (MRD) as an acceptable accelerated approval endpoint in multiple myeloma (MM). The data from the meta-analysis studies established the clinical benefit of MRD negativity in certain hematological cancers such as MM. Objectives: The primary objective of this qualitative research study is to assess hematology and oncology consultants’ opinions and experiences on the adequacy of using minimal residual disease (MRD) as an intermediate endpoint in early- phase clinical trials in multiple myeloma (MM) for fast-track approval of drugs and biological products in the Saudi Food and Drug Authority. That may include using MRD in MM in both settings: newly diagnosed and relapsed/refractory MM. The secondary objective is to gather information about the feasibility and availability of sensitive methods for detecting MRD in the context of real-world medical practice and clinical trials in Saudi Arabia. Study Design: The study design is a qualitative approach to interviewing 30 registered male, or female physicians specialized in hematology and oncology in Saudi Arabia. The interviews will be conducted in two ways: a single focus group and several face-to-face interviews. The participants should have more than 1 year of experience post-fellowship training. The participants will be invited for an interview via email or phone. A predetermined set of semi-structured questions is to be asked in the same order to each participant. The topic of questions will include the definition of MRD, clinical and research significance of MRD, MRD detection thresholds (e.g., 10^-5 vs. 10^-6), duration of MRD negativity at the complete response, correlation with other clinical endpoints such as progression-free survival (PFS) and overall survival (OS). The interviews will be conducted by scientific oncology and hematology evaluation experts at the Saudi Food and Drug Authority who have considerable experience in engaging in personal discussion. This qualitative study has about 5–10 semi-structured one-to-one interviews of hematology and oncology consultants performed at a convenient time for each doctor. Moreover, the discussions in focus groups can be as small as four participants. Qualitative data will be prepared and analyzed by an expert in data analysis. Citation Format: Tariq Hassan Alqurayshah, Albandari Alnasser, Tariq Alqurayshah. A qualitative research study on hematology and oncology consultants’ experiences and opinions on using minimal residual disease (MRD) as a fast-track approval endpoint in early-phase clinical trials in multiple myeloma in Saudi Arabia [abstract]. In: Proceedings of the AACR Special Conference: Liquid Biopsy: From Discovery to Clinical Implementation; 2024 Nov 13-16; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(21_Suppl):Abstract nr B007.