Quality of Reporting in Oncology Randomized Controlled Trials

摘要

Randomized controlled trials (RCTs) are important for evidence-based medicine; however, their quality of reporting remains to be evaluated. The aim of this study was to assess the quality of the report concerning solid tumor medication. Articles were searched in PubMed to identify all oncology phase III RCTs published from 2011 to 2015, and the results were classified manually through Endnote X7.0 software. Registration rate, primary end point (PEP) consistency, positive result rate, enrollment time point, outcome feedback in the registry, and publish time zone were extracted and assessed. The overall registration rate was higher than years before; nevertheless, a portion of trials showed PEP discrepancies and enrolled patients before registration in either journal formats. Trials published in top 5 general medical journals paid more attention to results feedback on registration websites and were more prompt with publication after study accomplishment. Our data suggested general medical journals may be more rigorous compared to oncology journals but identified a preference for positive results. On the whole, RCTs published between 2011 and 2015 seemed fairly standardized. Surveillance in registry and outcome feedback still needs to be strengthened for the stringency and reliability of clinical trials in solid tumor medication territory.