To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting

Abstract

Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands, as any bias introduced at the outset of the clinical trial would cascade down to the analysis and eventually the reporting of the results. The common study designs for oncology drugs, their challenges, the current perspectives (and dilemmas) in the industry on choosing the right endpoints/estimands, design and reporting biases, and the roles of medical writers in facing these challenges are discussed in this article.