Selective exclusion of treatment arms in multi-arm randomized clinical trials

Law, Matthew G. and Emery, Sean (2003) Selective exclusion of treatment arms in multi-arm randomized clinical trials. Statistics in Medicine, 22 1: 19-30. doi:10.1002/sim.1308


Author Law, Matthew G.
Emery, Sean
Title Selective exclusion of treatment arms in multi-arm randomized clinical trials
Journal name Statistics in Medicine   Check publisher's open access policy
ISSN 0277-6715
1097-0258
Publication date 2003-01-15
Sub-type Article (original research)
DOI 10.1002/sim.1308
Open Access Status Not yet assessed
Volume 22
Issue 1
Start page 19
End page 30
Total pages 12
Place of publication Chichester, West Sussex United Kingdom
Publisher John Wiley & Sons
Language eng
Abstract In this paper we discuss a design for multi-arm randomized clinical trials (RCTs) in which clinicians and their patients can selectively exclude one of the randomized treatment arms. This approach has the advantage that it should expedite protocol development, and allow easier and faster recruitment of patients into the trial. However, to preserve the randomized nature of treatment comparisons, not all recruited patients can be included in all treatment comparisons. This dictates that treatment arms are compared in a pairwise fashion, and that the numbers of patients included in different treatment comparisons may not be equal. The total trial size of a multi-arm RCT that allowed selective exclusion of arms would be greater than the size of an equivalent standard multi-arm RCT. However, the duration of time taken to recruit the study would be reduced. The implications for the design, monitoring and analysis of such RCTs are discussed.
Keyword Design
Randomized clinical trial
Sample size
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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