Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols

Abstract Background Master protocols, classified as basket trials, umbrella trials, and platform trials, are novel designs that investigate multiple hypotheses through concurrent sub-studies (e.g., multiple treatments or populations or that allow adding/removing arms during the trial), offering enhanced efficiency and a more ethical approach to trial evaluation. Despite the many advantages of these designs, they are infrequently used. Methods We conducted a landscape analysis of master protocols using a systematic literature search to determine what trials have been conducted and proposed for an overall goal of improving the literacy in this emerging concept. On July 8, 2019, English-language studies were identified from MEDLINE, EMBASE, and CENTRAL databases and hand searches of published reviews and registries. Results We identified 83 master protocols (49 basket, 18 umbrella, and 16 platform trials). The number of master protocols has increased rapidly over the last five years. Most have been conducted in ...

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PID https://www.doi.org/10.6084/m9.figshare.c.4671194
PID https://www.doi.org/10.6084/m9.figshare.c.4671194.v1
PID https://www.doi.org/10.1186/s13063-019-3664-1
URL https://dx.doi.org/10.6084/m9.figshare.c.4671194.v1
URL https://dx.doi.org/10.1186/s13063-019-3664-1
URL https://dx.doi.org/10.6084/m9.figshare.c.4671194
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Author Park, Jay J. H
Author Siden, Ellie
Author Zoratti, Michael J.
Author Dron, Louis
Author Harari, Ofir
Author Singer, Joel
Author Lester, Richard T.
Author Thorlund, Kristian
Author Mills, Edward J.
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Collected From Datacite
Hosted By figshare
Publication Date 2019-09-19
Publisher figshare
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keyword FOS: Sociology
keyword FOS: Biological sciences
keyword FOS: Health sciences
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Source https://science-innovation-policy.openaire.eu/search/dataset?datasetId=dedup_wf_001::9d9038a7f8997fe9dbb3e70f10a87239
Author jsonws_user
Last Updated 14 January 2021, 13:34 (CET)
Created 14 January 2021, 13:34 (CET)