Quality evaluation of investigator-initiated trials using post-approval cancer drugs in Japan.

ABSTRACT: Investigator-initiated trials (IIT) are important aspects of medical research and have contributed substantially to modern oncology. IIT using post-approval drugs have been conducted by domestic institutions in Japan. Data from the present study were obtained by all IIT registered clinical trials for five cancers (lung, colorectal cancer, gastric cancer, liver cancer, and breast cancer) using drugs approved from 1999 to 2009 in Japan. Kaplan-Meier method, analysis of variance (anova), and Kruskal-Wallis test were used to estimate time to enrolment completion (TTEC) and time to enrolment per patient (TTEP). Of 1222 trials eligible for analysis, 465 trials (38%) completed enrolment to the studies, and 203 trials (17%) published results. In the distribution according to trial phase, 98 (8%) w

SUBMITTER: Kondo S 

PROVIDER: S-EPMC5448621 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature