|
Abstract:
|
Master protocols are protocols that investigate multiple drugs, multiple populations or both. Master protocols include umbrella trials, basket trials, and platform trials. Umbrella trials match multiple drugs to corresponding sub-populations. Basket trials group multiple populations sharing a common molecular marker or pathophysiological characteristic in a study with a single drug. Platform trials move multiple drugs through a study in an assembly-line fashion using a common infrastructure, the “platform”. This presentation will discuss how these innovative designs may improve the degree to which drug development meets the needs of both clinical trial participants and patients.
|
