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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Published in:	Clinical trials (London, England) Vol. 14; no. 5; p. 451
Main Authors:	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
Format:	Journal Article
Language:	English
Published:	England 01.10.2017
Subjects:	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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Abstract	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.
AbstractList	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. 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.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.
Author	Kaplan, Richard Cafferty, Fay H Brown, Louise Maughan, Timothy Parmar, Mahesh Kb Sydes, Matthew R Choodari-Oskooei, Babak Phillips, Patrick Pj Langley, Ruth E Spears, Melissa R James, Nicholas D Rowley, Sam Royston, Patrick J Paton, Nicholas
Author_xml	– sequence: 1 givenname: Mahesh Kb surname: Parmar fullname: Parmar, Mahesh Kb organization: 1 MRC Clinical Trials Unit at UCL, University College London, London, UK – sequence: 2 givenname: Matthew R surname: Sydes fullname: Sydes, Matthew R organization: 1 MRC Clinical Trials Unit at UCL, University College London, London, UK – sequence: 3 givenname: Fay H surname: Cafferty fullname: Cafferty, Fay H organization: 1 MRC Clinical Trials Unit at UCL, University College London, London, UK – sequence: 4 givenname: Babak surname: Choodari-Oskooei fullname: Choodari-Oskooei, Babak organization: 1 MRC Clinical Trials Unit at UCL, University College London, London, UK – sequence: 5 givenname: Ruth E surname: Langley fullname: Langley, Ruth E organization: 1 MRC Clinical Trials Unit at UCL, University College London, London, UK – sequence: 6 givenname: Louise surname: Brown fullname: Brown, Louise organization: 1 MRC Clinical Trials Unit at UCL, University College London, London, UK – sequence: 7 givenname: Patrick Pj surname: Phillips fullname: Phillips, Patrick Pj organization: 1 MRC Clinical Trials Unit at UCL, University College London, London, UK – sequence: 8 givenname: Melissa R surname: Spears fullname: Spears, Melissa R organization: 1 MRC Clinical Trials Unit at UCL, University College London, London, UK – sequence: 9 givenname: Sam surname: Rowley fullname: Rowley, Sam organization: 1 MRC Clinical Trials Unit at UCL, University College London, London, UK – sequence: 10 givenname: Richard surname: Kaplan fullname: Kaplan, Richard organization: 1 MRC Clinical Trials Unit at UCL, University College London, London, UK – sequence: 11 givenname: Nicholas D surname: James fullname: James, Nicholas D organization: 2 Faculty of Health, Education and Life Sciences, Birmingham City University, Birmingham, UK – sequence: 12 givenname: Timothy surname: Maughan fullname: Maughan, Timothy organization: 3 University of Oxford, Oxford, UK – sequence: 13 givenname: Nicholas surname: Paton fullname: Paton, Nicholas organization: 4 National University of Singapore, Singapore – sequence: 14 givenname: Patrick J surname: Royston fullname: Royston, Patrick J organization: 1 MRC Clinical Trials Unit at UCL, University College London, London, UK
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Title	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
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