4/15/2020

Master protocols can increase efficiency of clinical trials while reducing risks to subjects. A master protocol compares multiple different investigational products with one placebo within one protocol. An adaptive design may be built into the protocol so that a substudy could be eliminated if the data warrants. Read our blog on adaptive design for further information.

Many stakeholders are unfamiliar with master protocol studies and are looking for additional resources. The Food and Drug Administration (FDA) released a draft guidance on their use. Because of the need for faster outcome information from COVID-19 clinical trials, the Clinical Trials Transformation Initiative (CTTI) opened a comment period for their draft resources on master protocols. The intent of their resources is to further guide and support stakeholders.

Comment here through April 24, 2020.

- The Clinical Pathways Team

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