Princess Margaret Cancer Centre, Division of Medical Oncology and Hematology, University Health Network, 7-723 700 University Avenue, Toronto, ON, M5G2M9, Canada.
Sackler school of medicine, Tel-Aviv University, Tel-Aviv, Israel.
Invest New Drugs. 2017 Dec;35(6):827-833. doi: 10.1007/s10637-017-0510-8. Epub 2017 Sep 14.
Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (p<0.001), multicenter trials (p<0.001) and publication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.
背景 关于癌症 I 期临床试验报告完整性的数据在出版物中是缺乏的。
方法 检索 ClinicalTrials.gov 数据库中已完成的报告结果的成人癌症 I 期临床试验。检索 PubMed 以查找在 2016 年 11 月 1 日之前发表的匹配的原始出版物。使用 28 分制（2=完整；1=部分；0=无报告）对与研究设计、结局测量和安全概况相关的 14 项内容，比较原始出版物与 ClinicalTrials.gov 数据库的报告。记录原始出版物与 ClinicalTrials.gov 之间的不一致。使用线性回归来确定与不完整报告相关的因素。
结果 在对 ClinicalTrials.gov 中 583 项试验进行审查后，确定了 163 项匹配的原始出版物。在 25%的试验中，出版物报告了 ClinicalTrials.gov 中未出现的结局。在 47%的试验中，出版物升级、降级或省略了结局。总体中位数报告评分 23/28（四分位距 21-25）。在超过 25%的出版物中，未完全报告的项目包括：纳入标准（29%）、主要结局定义（26%）、次要结局定义（53%）、不良事件（71%）、严重不良事件（80%）和研究开始日期和数据库锁定日期（91%）。更高的报告评分与 I 期（而非 I/II 期）试验（p<0.001）、多中心试验（p<0.001）和发表在影响因子较低的期刊上的出版物（p=0.004）相关。
结论 与 ClinicalTrials.gov 条目相比，早期癌症试验的原始出版物中报告的结果经常不一致或不完整。ClinicalTrials.gov 可能提供新癌症药物试验更全面的数据。
