FDA, NCI study will serve as prototype for streamlined pragmatic trials

Two U.S. government agencies, two pharmaceutical companies and an academic cooperative trials group are collaborating to conduct a pragmatic clinical trial of a combination therapy for advanced non-small cell lung cancer. They hope the trial, which FDA has dubbed Project Pragmatica, will be a model for quickly answering urgent questions that can shape clinical practice.

Richard Pazdur, director of FDA’s Oncology Center of Excellence, and NCI Director Monica Bertagnolli described the origins and goals of Project Pragmatica Thursday at the Friends of Cancer Research annual meeting. ...