Japan will Loosen Restrictions on Clinical Trials, Allowing Use of Outside Data for Evaluations

In a push to speed drug approval times amid the coronavirus pandemic, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is finalizing plans to permit drug companies to supplement or replace their own clinical trials with data from patients who have taken the drug in question elsewhere.

The use of real-world data in the drug approval process has not been permitted in Japan before. It is sometimes used in the United States and the European Union, where the time it takes for a drug to get approved and be marketed is generally faster than in Japan.

Traditional clinical trials, in Japan and elsewhere, mandate dispensing one group of patients the drug being evaluated and another group a placebo. However, it has become increasingly hard for researchers to enlist enough participants in trials. If the new plans are approved, researchers will be able to replace the use of placebos with evaluations of how the drug in question has been used in other settings.

Japanese health officials recognize that quicker approval of new drugs, provided that safety and efficacy can still be assured, would bring more new therapies to patients faster.