Elements for successful clinical trial operationalization

Clinical studies in an adaptive master protocol are helping speed targeted therapies and diagnostics to market. These novel frameworks take advantage of improved precision medicine, technology and analytics to bring flexibility, speed and economies of scale to clinical development not readily available with traditional randomized controlled trials.

Master protocol trials require expertise in the design, statistics and methods of adaptive trials as well as in operational preparation and execution. IQVIA Biotech's extensive experience with adaptive master protocols, including basket, umbrella and platform trials, offers lessons for success to biotech sponsors considering initiating or joining these types of trials.