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Background: In September 2018 the FDA provided a draft guidance on master protocols reflecting an increased interest in these designs by industry.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...
Main Authors: | , , , , , , |
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Format: | Article |
Language: | English |
Published: |
Elsevier
2019-09-01
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Series: | Contemporary Clinical Trials Communications |
Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865419301103 |