Publication and Reporting Results of Clinical Trials Initiated by Investigators

Abstract

Investigator-initiated clinical trials provide important knowledge and insights for rational use of approved drugs and off-label use. However, it is unclear whether those results have been utilized effectively through publication or reporting to the clinical trial registration database. In this article, we investigated publication and reporting of the results of investigator-initiated clinical trials conducted in Clinical Trials Core Hospitals in Japan. We selected interventional trials of malignant tumor registered in UMIN-CTR (Clinical Trial Registry) between April 2009 and March 2015, whose completion was registered by March 1st 2017. We calculated proportion of publication of trial results and registering the results on UMIN-CTR. We identified 142 interventional trials across 7 Clinical Trials Core Hospitals. Over all, the proportion of publication of clinical trials was 73.0% (103/141). The proportion of registering results on UMIN-CTR was 4.9% (7/142). We found that there were about 30% of all clinical trials that were not effectively used because the results were not published. Apparent variations also appeared between hospitals. It is essential to motivate investigators for understanding the necessity of publication. We also found that UMIN-CTR was poorly managed regarding to the trial results. As the newly enacted Clinical Trials Act mandates reporting of specified clinical trials to jRCT (Japan Registry of Clinical Trials), the proportion of reporting results and its utilization will be improved.