New England Journal of Medicine
July 6, 2017 Vol. 377 No. 1
The Changing Face of Clinical Trials: Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both
Woodcock and L.M. LaVange
Master protocols come in different sizes and shapes but share many commonalities. All require increased planning efforts and coordination to satisfy the objectives of different stakeholders. Innovative design elements help ensure that maximum information is obtained from the research effort, and the infrastructure required for implementation increases data quality and trial efficiencies, as compared with those in stand-alone trials. If designed correctly, master protocols can last many years, even decades, with innovations from the laboratory translating quickly to clinical evaluation. As the targets for new drugs become more and more precise, there is no alternative but to move forward with these coordinated research efforts.