Advanced search
524
Views
13
CrossRef citations to date
0
Altmetric
Original Articles

Optimal Timing for Interim Analyses in Clinical Trials

&
Pages 1067-1080
Received 01 Nov 2011
Accepted 16 May 2012
Published online: 19 Aug 2013
 

In clinical trials, interim analyses are often performed before the completion of the trial. The intention is to possibly terminate the trial early or adjust the sample size. The time of conducting an interim analysis affects the probability of the early termination and the number of subjects enrolled until the interim analysis. This influences the expected total number of subjects. In this study, we examine the optimal time for conducting interim analyses with a view to minimizing the expected total sample size. It is found that regardless of the effect size, the optimal time of one interim analysis for the early termination is approximately two-thirds of the planned observations for the O'Brien–Fleming type of spending function and approximately half of the planned observations for the Pocock type when the subject enrollment is halted for the interim analysis. When the subject enrollment is continuous throughout the trial, the optimal time for the interim analysis varies according to the follow-up duration. We also consider the time for one interim analysis including the sample size adjustment in terms of minimizing the expected total sample size.

ACKNOWLEDGMENT

This research was supported in part by a Grant-in-Aid for Scientific Research of Seikei University, number Kyodo-2011-01.

Log in via your institution

Log in to Taylor & Francis Online

PDF download + Online access

  • 48 hours access to article PDF & online version
  • Article PDF can be downloaded
  • Article PDF can be printed
EUR 47.00 Add to cart

Purchase access via tokens

  • Choose from packages of 10, 20, and 30 tokens
  • Can use on articles across multiple libraries & subject collections
  • Article PDFs can be downloaded & printed
From EUR 400.00
per package
Learn more
* Local tax will be added as applicable
 

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.