ABSTRACT
Early-stage clinical trials in oncology are important not only for the primary investigation into safety and tolerability but also for the first look at the effectiveness of a therapeutics. With the increase in precision medicine approaches in oncology, these early-stage trials are also a first chance to investigate biomarker-driven patient selection ahead of full companion diagnostic development. It is key that the most appropriate molecular test is selected to ensure generation of the high-quality data needed to guide the choice of a patient’s treatment. The process of identifying the right molecular test starts by fully understanding a study’s specific clinical, technical and partner requirements and translating these into the criteria for assay selection. The next step is to select suitable assays and investigate their performance against these criteria. Successful incorporation of an assay into the clinical trial requires a strong team and effective communication between all partners, successful regulatory review and up-front preparation for patient selection. This section provides an outline for this process, highlighting key steps, providing useful examples and exploring recent advances in molecular testing in early-stage clinical trials.
