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

Ellie Siden | Zendy; Jay Park | Zendy; Michael J. Zoratti | Zendy; Louis Dron | Zendy; Ofir Harari | Zendy; Kristian Thorlund | Zendy; Edward J. Mills | Zendy

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

Author(s) -

Ellie Siden,

Jay Park,

Michael J. Zoratti,

Louis Dron,

Ofir Harari,

Kristian Thorlund,

Edward J. Mills

Publication year - 2019

Publication title -

contemporary clinical trials communications

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.678

H-Index - 14

ISSN - 2451-8654

DOI - 10.1016/j.conctc.2019.100406

Subject(s) - protocol (science) , computer science , systematic review , medical physics , medline , medicine , alternative medicine , pathology , political science , law

The terms 'master protocol', 'basket trial', 'umbrella trial', and 'platform trial' are inconsistently described. Careful treatment of these terms and adherence to the definitions set forth by the FDA will facilitate better understanding of these trial designs and allow them to be used broadly and to their full potential in clinical research. We encourage trial methodologists to use these trial designations when applicable.

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