LAUSR

The number of global clinical trials including Japan is increasing but still much lower than those including the USA and Europe. The regulatory requirements for clinical trials have been harmonized among Japan, USA, and Europe, and the quality of clinical trials is kept high in these regions. Xofluza (baloxavir marboxil) for influenza approved in Japan under the SAKIGAKE Designation System is a good example of clinical trials including Japan. To include Japan in more global clinical trials, stakeholders should work more collaboratively, and increase the perception that clinical trials can be conducted appropriately and efficiently in Japan. Further measures for better management of clinical trials should also be developed. These would ultimately lead to improved benefits for patients with timely access to new drugs.