ABSTRACT
BACKGROUND: The COVID-19 pandemic demanded pharmaceutical companies to urgently develop new drugs and vaccines. However, it has been said that there may be some regional differences in the volume of drug development during the pandemic. Therefore, the present study compared the number of phase 3 RCTs for COVID-19 conducted in the US, Europe, Japan, or the rest of the world since the pandemic began. METHOD(S): We searched ClinicalTrials.gov, EudraCT, and jRCT (Japan Registry of Clinical Trials) for "double-blind or more, randomized, in progress or completed" We collected a list of phase 3 trials of COVID-19 that met the criteria of "double-blind or greater, randomized, ongoing, or completed." This list was divided into prophylactic and therapeutic according to primary objective. Using this list, the number of clinical trials conducted in Japan, the US, and the EU/UK were aggregated, by sponsor and by site, respectively. RESULT(S): There were 430 trials that met the predefined criteria, of which 140 were prophylactic and 290 were therapeutic. By site, 133 trials were conducted in the US, 127 in the EU and UK, 41 in Japan, and 248 in other regions. By sponsor headquarters, 115 trials were conducted in the US, 115 in the EU and UK, 19 in Japan, and 181 in the rest of the world. CONCLUSION(S): The regional difference in the number of clinical trials for COVID-19 was found. Fewer phase 3 trials of COVID-19 were conducted in Japan than in the US and Europe, suggesting that the drug development in Japan may be slower or less active among the three major regions during the worldwide pandemic.