Introduction to FDA's"Master Protocols for Drug and Biological Product Development Guidance for Industry(Draft)"
Master protocol is a protocol designed with multiple substudies,which may have different objectives and involve coordinated efforts to evaluate one or more medical products in one or more diseases or disease subtypes within the overall study structure.A well-designed and conducted trials using master protocols can accelerate drug development by maximizing the amount of information obtained from the research effort.In December 2023,FDA issued the"Master Protocols for Drug and Biological Product Development Guidance for Industry(Draft)"to describe the requirements for the design,implementation and analysis of clinical trials using the master protocol.This paper introduces the guidance in detail,focusing on the random umbrella and platform design that provide substantial evidence for safety and effectiveness,and discusses the important considerations for the design and analysis of the master protocol.Combined with the requirements of the current guidance in China,the adoption of the master protocol design is discussed from the perspective of regulation,in order to promote the application of the master protocol in China and guide the regulatory practice.
Food and Drug Administration(FDA)master protocolumbrella trialplatform trialbasket trialconcurrent controlguidance
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