Master protocols and other innovative trial designs in inflammation and immunology to expedite clinical drug development.

ABSTRACT

Master protocol designs, such as umbrella and basket studies, allow multiple compounds or multiple target populations to be evaluated simultaneously within a single protocol, and have been widely adopted in oncology clinical trials. These novel designs can also be applied in other therapeutic areas, where they could have several benefits over conducting traditional randomized controlled trials. Here, we detail Pfizer's recent implementations of master protocol designs in inflammation and immunology clinical studies, focusing on the opportunities for cost and resource savings and how these designs can expedite the time required to bring new treatments to patients in need.