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Could master protocols be adapted for effectiveness-implementation hybrid studies?


ABSTRACT:

Background

Master protocols leverage a common trial infrastructure for launching multiple sub-studies. Translational research aims to progress scientific discoveries toward public health impact, which depends on establishing an intervention's efficacy, effectiveness in real-world conditions, and successful strategies for implementation. While master protocols have been designed to improve the efficiency of clinical trials as sub-studies addressing a particular disease, their application with effectiveness-implementation hybrid studies is yet to be explored. The aim of this study was to develop recommendations for adapting mater protocol methods for effectiveness-implementation research.

Methods

A method of consultation with translational research networks was undertaken betw

SUBMITTER: Chapman JJ 

PROVIDER: S-EPMC12625322 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature