Trial Design
Master Protocol
A master protocol is a single overarching trial protocol that supports the simultaneous evaluation of multiple drugs, multiple diseases, or multiple sub-populations, typically under one IND and shared operational infrastructure.
Master protocols come in three main forms: basket trials (one drug across multiple cancers sharing a biomarker), umbrella trials (multiple drugs against multiple molecular subtypes of one cancer), and platform trials (multiple drugs added and removed over time against a common control). FDA's 2022 Master Protocols Guidance defines the regulatory expectations.
Master protocols reduce duplication of regulatory review, IRB submissions, and site activation, but require sophisticated statistical infrastructure and IRB/sponsor governance to handle protocol amendments cleanly.
References
Related terms
Platform Trial
A platform trial is a clinical trial that evaluates multiple investigational treatments against a common control under a single master protocol, with treatments added or dropped over time based on accumulating evidence.
Basket Trial
A basket trial is a clinical trial that tests one investigational therapy across multiple disease types (typically cancers) that share a common molecular biomarker or genetic alteration.
Umbrella Trial
An umbrella trial is a clinical trial that evaluates multiple targeted therapies in patients with a single disease, stratified by molecular or genetic subtype, under one master protocol.
Adaptive Trial Design
An adaptive trial design is a clinical trial that uses pre-specified rules to modify aspects of the study (sample size, randomization ratio, dose, treatment arms, endpoints) based on accumulating interim data, without compromising scientific validity.
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