Preclinical Efficacy in Investigator’s Brochures: Stakeholders’ views on measures to improve Completeness and Robustness

Abstract

Research ethics committees (RECs) and regulatory agencies assess whether the benefits of a proposed early-stage clinical trial outweigh the risks based on preclinical studies reported in investigator’s brochures (IBs). Recent studies have indicated that preclinical evidence presented in IBs is reported in a way that does not enable proper risk-benefit assessment. We interviewed different stakeholders (regulators, REC members, industry representatives, preclinical and clinical researchers, ethicists, and metaresearchers) about their views on measures to increase the completeness and robustness of preclinical evidence reporting in IBs.