Testing many treatments within a single protocol over 10 years at MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols

There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone often we find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has b...

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Vydáno v:Clinical trials (London, England) Ročník 14; číslo 5; s. 451
Hlavní autoři: Parmar, Mahesh Kb, Sydes, Matthew R, Cafferty, Fay H, Choodari-Oskooei, Babak, Langley, Ruth E, Brown, Louise, Phillips, Patrick Pj, Spears, Melissa R, Rowley, Sam, Kaplan, Richard, James, Nicholas D, Maughan, Timothy, Paton, Nicholas, Royston, Patrick J
Médium: Journal Article
Jazyk:angličtina
Vydáno: England 01.10.2017
Témata:
Clinical Protocols - standards
Clinical Trials, Phase III as Topic
Humans
London
Male
Outcome Assessment, Health Care
Patient Selection
Randomized Controlled Trials as Topic
Research Design
Treatment Outcome
London
randomised trials
basket
multi-stage
umbrella
platform
Multi-arm
ISSN:1740-7753, 1740-7753
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Shrnutí:There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone often we find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this article, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.
Bibliografie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:1740-7753
1740-7753
DOI:10.1177/1740774517725697