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Original Articles

Strategies for Including Patients Recruited During Interim Analysis of Clinical Trials

&
Pages 1211-1225
Received 15 Apr 2007
Accepted 15 Jun 2007
Published online: 14 Nov 2007
 

In clinical trials a periodical check of safety and efficacy data is often needed. For organizational reasons it is rarely desirable to stop a trial during such an interim analysis. Therefore, new study patients are included in the trial while the interim analysis is ongoing. Disregarding the additional information provided by these interim patients would be unsatisfactory, especially for an office of regulatory affairs. Consequently, the rules for group sequential or adaptive decisions must be adjusted to the recruitment of interim patients. In this paper, two strategies for modifying study designs to consider the analysis of interim patients are proposed.

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