Keywords: clinical outcome assessment, patient-reported outcome, data standards, clinical trials, SDTM, ADaM
Clinical outcome assessments (COAs) are used to capture input from patients, their caregivers, and physicians concerning key symptoms and functional impacts in a scientifically rigorous manner such that this information can be incorporated into regulatory decision-making. To this end, COAs are increasingly being used to construct efficacy, tolerability, and safety endpoints in drug development programs. As more and more COA data are collected and reviewed in the formulation of drug approval decisions, it is crucial these data be captured and reported in an organized way that preserves data integrity and traceability. Topics we aim to address through this discussion include, but are not limited to: (1) experiences in capturing and preparing COA data for submission to regulatory bodies; (2) regulator experiences with locating and analyzing COA data within regulatory application submissions; (3) whether or how some of the rules and conventions currently employed to create data standards may need to be re-thought for COAs; (4) how to handle COAs that are copyrighted; and (5) the scope of information that ought to be included in ADaM supplements for COAs.