ABSTRACT
Since the establishment of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), many countries in the world have rapidly improved their clinical trial performance, and the era has come to compare the clinical trial performance of each country. Japan's clinical trials are considered excellent quality, but costly and slow. In this study, we examined the speed of enrollment period in clinical trials. We surveyed clinical trials from January 1, 2010, to December 31, 2019, covering the top 10 pharmaceutical companies in each global sales ranking (Global 10) and the Japanese sales ranking (Japan 10). Clinical trial data were obtained from ClinicalTrials.gov, a clinical trial registration information database, and the speed of participant enrollment (cases/month) was compared for each phase of the trials. The number of clinical trials conducted during the 10 years was 8938 trials for Global 10 and 1439 trials for Japan 10. Comparing the speed of participant enrollment by phase, Japan 10 was significantly faster in phase 1 for both healthy subjects and oncology patients. [Japan 10: Global 10; 15.1 : 12.0 cases/month (healthy subjects) and 5.5 : 1.8 cases/month (oncology), respectively. p < 0.001]. Global 10 was also significantly faster in phase 3. [Japan 10: Global 10; 12.4: 36.9 cases/month, p < 0.001). No significant difference was observed in phase 2 and phase 4. There was a possibility that the speed of enrollment differed by phase between global companies and Japanese domestic companies.
