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Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome

Overview of attention for article published in Trials, January 2013
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Title
Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome
Published in
Trials, January 2013
DOI 10.1186/1745-6215-14-23
Pubmed ID
Authors

Babak Choodari-Oskooei, Mahesh KB Parmar, Patrick Royston, Jack Bowden

Abstract

In 2011, Royston et al. described technical details of a two-arm, multi-stage (TAMS) design. The design enables a trial to be stopped part-way through recruitment if the accumulating data suggests a lack of benefit of the experimental arm. Such interim decisions can be made using data on an available 'intermediate' outcome. At the conclusion of the trial, the definitive outcome is analyzed. Typical intermediate and definitive outcomes in cancer might be progression-free and overall survival, respectively. In TAMS designs, the stopping rule applied at the interim stage(s) affects the sampling distribution of the treatment effect estimator, potentially inducing bias that needs addressing.

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Mendeley readers

The data shown below were compiled from readership statistics for 31 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United States 1 3%
France 1 3%
Unknown 29 94%

Demographic breakdown

Readers by professional status Count As %
Researcher 14 45%
Student > Ph. D. Student 5 16%
Other 4 13%
Professor 1 3%
Student > Master 1 3%
Other 1 3%
Unknown 5 16%
Readers by discipline Count As %
Medicine and Dentistry 12 39%
Mathematics 8 26%
Nursing and Health Professions 1 3%
Decision Sciences 1 3%
Economics, Econometrics and Finance 1 3%
Other 2 6%
Unknown 6 19%