Several regulatory guidelines and recommendations have been developed in order to support correct use of interim analyses of randomized controlled trials (RCTs). Incorrectly performed unblinding and repeated testing in a trial may have detrimental consequences on both the validity and the precision of the trial’s findings.
The authors of (1) reviewed pediatric RCTs that reported on Data Monitoring Committees (DMC), interim analysis or early termination in 8 general medical and pediatric journals during 2005-2007.
Of 648 paediatric trials 110 (17%) reported on DMCs, interim analyses or early stopping. Strict predefined stopping rules were reported in 10 of 23 trials. No adjustment for repeated testing was reported in 11 of 33 trials.
The authors conclude that heterogeneous practices and apparent shortcomings jeopardize the valdity of the results and that easily accessible guidelines are needed.
1. Fernandes RM, van der Lee JH, Offringa M. Data monitoring committees and early termination in paediatric trials. Acta Paediatr 2011;100:1386-1392.