Departamento da Criança e da Família, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte-EPE, Laboratório de Farmacologia Clínica e Terapêutica, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Portugal.
BMC Pediatr. 2009 Dec 13;9:77. doi: 10.1186/1471-2431-9-77.
Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials.
We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination.
110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods.
Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results.
基于数据监测委员会（DMC）的建议，对临床试验进行中期分析和提前终止的决策对试验的科学有效性和临床影响具有深远的意义。我们的目的是评估儿科试验中 DMC 组成和作用、中期分析和提前终止的报告频率和质量。
我们对 2005 年至 2007 年在四本普通期刊和四本儿科期刊样本中发表的随机对照临床试验进行了系统评价。我们使用全文数据库来识别报告 DMC、中期分析或提前终止的试验，并纳入儿童或青少年。提取了关于一般试验特征、偏倚风险以及 DMC 组成和作用、中期分析和提前终止的一系列参数的信息。
在该样本的 648 项儿科试验中，有 110 项（17%）报告了 DMC 或中期分析或提前停止，并被纳入；68 项来自普通期刊，42 项来自儿科期刊。在纳入的 110 项试验中，有 89 项（81%）报告了 DMC 的存在；62 篇论文，包括 46 篇报告了 DMC 的论文（52%），也提供了关于中期分析的信息。没有一篇论文充分报告了所有 DMC 参数，有 9 篇（15%）报告了所有中期分析细节。在 32 项提前终止的试验中，有 22 项（69%）未报告预设的停止指南，有 15 项（47%）未提供关于统计监测方法的信息。
儿科试验中关于 DMC 组成和作用、中期分析结果和提前终止的报告不完整且不一致。我们提出了一套最小的报告参数，使读者能够评估试验结果的有效性。
