Japan to use clinical data from outside trials to boost drug approval

In a bid to help new drugs reach the market faster, Japan’s health ministry is working on a new set of guidelines that it will release in the next fiscal year to allow pharmaceutical manufacturers to use data from outside clinical studies.

Reportedly, the health ministry will accept medical information from patients who have consumed the drugs in another setting. The requirement for clinical trials, including the number of volunteers and the participants, will also be relaxed. These guidelines will be rolled out before this fiscal year in March.

Notably, through this, the Japanese health ministry aims at making certain drugs available whose conventional clinical trials may be difficult.

Seemingly, these trials are carried out in a random manner and are controlled, in which a certain group of volunteers is given the drug dosage and the others receive a placebo, and neither doctors nor patients know which is which. However, during the treatment of rare diseases, researchers may not be able to line up the required number of participants.  

It is worth mentioning that, Japan provides a fast-track drug review alternative that allows certain steps to be postponed until later, reducing the length of the process which may otherwise take nearly a year. But this does not restrict the drug makers from submitting crucial clinical trial results.

For the record, the new Japanese guidelines support the use of real-world data in the drug approval process to facilitate drug development, along with noting other concerns regarding the possibility of drug companies re-analyzing the data in various kinds until they get the required results.

Speaking along similar lines, the health ministry has started accumulating real-world data on certain severe medical conditions like diabetes and cancer.

According to the National Institutes of Biomedical Innovation, Health, and Nutrition, the institute is working on a pool of database of information about coronavirus affected patients which has been collected from university hospitals, and other sources, that will be shared with medical institutions and the drug makers.

Source Credit: https://asia.nikkei.com/Business/Pharmaceuticals/Japan-to-use-data-from-outside-clinical-trials-in-drug-approvals