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Incorporating intermediate binary responses into interim analyses of clinical trials: A comparison of four methods
Author(s) -
Whitehead Anne,
Sooriyarachchi Marina Roshini,
Whitehead John,
Bolland Kim
Publication year - 2007
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.3046
Subject(s) - interim , interim analysis , statistics , sample size determination , randomization , clinical trial , econometrics , wald test , odds , type i and type ii errors , logistic regression , mathematics , computer science , medicine , statistical hypothesis testing , archaeology , history
In clinical trials with a long period of time between randomization and the primary assessment of the patient, the same assessments are often undertaken at intermediate times. When an interim analysis is conducted, in addition to the patients who have completed the primary assessment, there will be those who have till then undergone only intermediate assessments. The efficiency of the interim analysis can be increased by the inclusion of data from these additional patients. This paper compares four methods of increasing information based on model‐free estimates of transition probabilities to incorporate intermediate assessments from patients who have not completed the trial. It is assumed thatthe observations are binary and that there is one intermediate assessment. The methods are the score and Wald approaches, each with the log‐odds ratio and probability difference parameterizations. Simulations show that all four approaches have good properties in moderate to large sample sizes. Copyright © 2007 John Wiley & Sons, Ltd.