Adaptive Designs for Non-inferiority Trials with Multiple Experimental Treatments

The increase in the popularity of non-inferiority clinical trials represents the increasing need to search for substitutes for some reference (standard) treatments. A new treatment would be preferred to the standard treatment if the benefits of adopting it outweigh a possible clinically insignifican...

Full description

Saved in:
Bibliographic Details
Published in:Statistical methods in medical research 2018-11, Vol.27 (11), p.3255-3270
Main Authors: Xu, Wenfu, Hu, Feifang, Cheung, Siu Hung
Format: Article
Language:English
Subjects:
Adaptive designs
Bias
Clinical research
Clinical trials
Efficacy
Inferiority
Medical research
Patients
Popularity
Power
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The increase in the popularity of non-inferiority clinical trials represents the increasing need to search for substitutes for some reference (standard) treatments. A new treatment would be preferred to the standard treatment if the benefits of adopting it outweigh a possible clinically insignificant reduction in treatment efficacy (non-inferiority margin). Statistical procedures have recently been developed for treatment comparisons in non-inferiority clinical trials that have multiple experimental (new) treatments. An ethical concern for non-inferiority trials is that some patients undergo the less effective treatments; this problem is more serious when multiple experimental treatments are included in a balanced trial in which the sample sizes are the same for all experimental treatments. With the aim of giving fewer patients the inferior treatments, we propose a response-adaptive treatment allocation scheme that is based on the doubly adaptive biased coin design. The proposed adaptive design is also shown to be superior to the balanced design in terms of testing power.
ISSN:0962-2802
1477-0334
DOI:10.1177/0962280217695579