Reporting of master protocols towards a standardized approach: A systematic review

Background: In September 2018 the FDA provided a draft guidance on master protocols reflecting an increased interest in these designs by industry. Master protocols refer to a single overarching protocol developed to evaluate multiple hypotheses and may be further categorized as basket, umbrella, and...

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Bibliographic Details
Main Authors: Ellie G. Siden, Jay JH. Park, Michael J. Zoratti, Louis Dron, Ofir Harari, Kristian Thorlund, Edward J. Mills
Format: Article
Language:English
Published: Elsevier 2019-09-01
Series:Contemporary Clinical Trials Communications
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865419301103