Best Practice of RBQM in Solid Tumor Oncology Trials

Risk-based quality management (RBQM) has evolved from simple risk-based monitoring to become the defacto method for implementing ICH E8(r1) section 3’s requirements for designing quality into clinical studies. This includes adopting Quality-by-Design (QbD) principles and Critical-to-Quality (CtQ) Factors. Oncology studies are notoriously complex due to the various disease settings, various derived endpoints, combination therapies and innovative treatment modalities. Use of RBQM tools and central statistical monitoring based on CtQ factors can reduce site burden and reduce Sponsor CRA on-site and remote monitoring while enhancing focus on ‘data-that-matters.’ Selection of critical variables and processes based on clinical endpoints is best achieved via a collaboration between Medical and Biostatistics. To support these steps, the Authors propose a standard core set of critical variables based on oncology efficacy endpoints in solid tumor studies.