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In group sequential trials, the interim results are more promising in the early termination of a trial either for efficacy or futility of the trial. This reduces the cost and time implications. Moreover, interim analyses play a key role to tackle the problem that arises due to adverse effects. In concern with the early stopping of trials, there are numerous stopping methods among them the Conditional power (CP) approach is best recommended. The CP approach provides the probability of getting significant results at the end of the study given the data observed so far. There are very few Indian studies that had incorporated the concept of CP and made decisions based on the results. This study popularises the CP approach detailing computing and its interpretation and is thereby facilitating clinical researchers to use this approach effectively. We have used real-time and hypothetical examples and illustrated the concept of CP under trend, CP under null, and CP under design. We suggest stopping the study for efficacy when the CP under null is greater than 80% and stopping the study for futility when CP under trend is less than 30%.
Author(s): Marimuthu S, Thenmozhi M, Joy M, Babu M, Sudarsanam TD, Jeyaseelan L
Publication type: Article
Publication status: Published
Journal: Indian Journal of Applied Research
Year: 2022
Volume: 12
Issue: 10
Pages: 51-55
Online publication date: 01/10/2022
Acceptance date: 01/10/2022
ISSN (print): 2249-555X
Publisher: World Wide Journals
URL: https://www.worldwidejournals.com/indian-journal-of-applied-research-(IJAR)/fileview/interpretation-and-estimation-of-conditional-power-in-interim-analyses-of-clinical-trials-often-ignored-in-decision-making-process_October_2022_2262756461_6412839.pdf
DOI: 10.36106/ijar/6412839
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