Review of patient-reported outcomes in multiple myeloma registrational trials: highlighting areas for improvement.

ABSTRACT: Over the past 13 years, there have been advances in characterizing the patient experience in oncology trials, primarily using patient-reported outcomes (PROs). This review aims to provide details on the PRO measures and analyses used in multiple myeloma (MM) registrational trials. We identified registrational trials supporting MM indications from 2007 to 2020 from FDA databases. Trial protocols, statistical analysis plans, and clinical study reports were reviewed for PRO measures used, collection methods, statistical analyses, baseline and instrument completion definitions, and thresholds for clinical meaningfulness. Twenty-five trials supporting 20 MM indications were identified; 17 (68%) contained submitted PRO data. Of the 17 trials, 14 were randomized controlled trials and the remainde

SUBMITTER: Fernandes LL 

PROVIDER: S-EPMC8408214 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature