Data Monitoring Committees (DMCs) recommended that interim analysis and early termination of clinical trials have far-reaching implications for a trial’s scientific validity and clinical impact. The goal was to determine how often researchers reported DMC makeup and roles, interim analysis, and early termination in pediatric studies. Researchers conducted a comprehensive evaluation of randomized controlled clinical trials published in four general and four pediatric journals between 2005 and 2007. They searched full-text databases for studies that included children or adolescents and reported on DMCs, interim analysis, or early termination. General trial features, risk of bias, and a collection of metrics related to DMC composition and roles, interim analysis, and early termination were all extracted.

In a sample, 110 of the 648 pediatric studies (17%) reported on DMC, interim analysis, or early halting, and were included; 68 from general journals and 42 from pediatric journals. DMCs were found in 89 of the 110 trials studied (81 %); 62 articles, including 46 of the 89 that reported on DMCs (52 %), also contained information on interim analyses. None of the papers adequately provided all DMC parameters, and only nine (15%) of the documents reported all provisional analysis information. 22 (69%) of the 32 trials that ended early did not offer information on predetermined termination rules, and 15 (47%) did not provide information on statistical monitoring measures. Reporting on DMC composition and duties, interim analysis results, and pediatric trial early termination is inconclusive and inconsistent. They suggest a set of reporting parameters that will enable the reader to evaluate the validity of trial outcomes.

 

Reference:bmcpediatr.biomedcentral.com/articles/10.1186/1471-2431-9-77