title: Inefficacy interim monitoring procedures in randomized clinical trials: the need to report.
abstract: If definitive evidence concerning treatment effectiveness becomes available from an ongoing randomized clinical trial, then the trial could be stopped early, with the public release of results benefiting current and future patients. However, stopping an ongoing trial based on accruing outcome data requires methodological rigor to preserve validity of the trial conclusions. This has led to the use of formal interim monitoring procedures, which include inefficacy monitoring that will stop a trial early when the experimental treatment appears not to be working. For participants, inefficacy monitoring is especially important as it ensures that they are not being treated worse than if they had not enrolled on the trial. We discuss the importance of reporting with trial results the formal interim inefficacy monitoring guidelines that were utilized, and, if none were used, the reasons for their absence. A survey of two leading medical journals suggests that this is not current practice.
authors.affiliation: Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA. korne@ctep.nci.nih.gov
authors.forename: Edward L
authors.initials: EL
authors.lastname: Korn
authors.forename: Boris
authors.initials: B
authors.lastname: Freidlin
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000191:economics; D057239:Early Termination of Clinical Trials; D019317:Evidence-Based Medicine; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods* / Q000592:standards*; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards; D012449:Safety; D013997:Time Factors; D016896:Treatment Outcome