[Interim analyses].
The methodological principles for the planning of interim analyses in a phase III clinical trial are presented in this article. The case for superiority, non-inferiority and futility, and the roles of Data Monitoring Committees are summarized. Several examples are presented to illustrate the methodology and to help investigators by better understanding and planning interim analyses in a phase III clinical trial.
Unité de Biostatistiques, Centre régional de lutte contre le cancer Val d'Aurelle-Paul Lamarque, Montpellier. Andrew.Kramar@valdorel.fnclcc.fr
Andrew
A
Kramar
Xavier
X
Paoletti
D026661:Clinical Trials Data Monitoring Committees; D017326:Clinical Trials, Phase III as Topic / Q000379:methods* / Q000592:standards; D003627:Data Interpretation, Statistical; D006801:Humans; D010934:Planning Techniques; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D018401:Sample Size; D016896:Treatment Outcome