Clinical Study

To those planning clinical studies

To those planning clinical studies

The Center for Clinical and Translational Research (CCTR) provides support and manages clinical studies (sponsor-initiated/investigator-initiated clinical studies) for their smooth conduct.

What are investigator-initiated clinical studies?

The 2002 revision of the Pharmaceutical Affairs Law made it possible for physicians themselves to plan and carry out clinical studies. Such “Investigator-initiated trials” are actively carried out with the following objectives for the development of new medical treatments.

  • For obtaining approval for a pharmaceutical product or medical device that has not been approved in the country, or for addition of new indications

    An investigator-initiated trial for obtaining approval under the Pharmaceutical Affairs Law for a pharmaceutical product or medical device that has been approved in another country or in other countries but not in Japan, or for the use of a pharmaceutical product or medical device that is being used off-label

  • Translational research that leads the fruits of academic research to practical applications

    Investigator-initiated studies at an early stage of development such as exploratory studies, dose-response studies, etc. to obtain clinical proof of concept in order to lead the fruits of basic research to practical application

  • Drug repositioning

    Investigator-initiated studies that identify new action mechanisms or new indications of existing drugs, or drugs whose development had been discontinued, to pursue their development as drugs with newfound effectiveness

In investigator-initiated studies

In investigator-initiated studies, the physicians themselves have to carry out numerous tasks that the pharmaceutical companies normally do in ordinary sponsor-initiated studies. The preparation of clinical study protocol, submission of the clinical trial protocol notification, procurement of the investigational product, management of monitoring, auditing and data processing, preparation of clinical study reports, etc. must all be compliant with GCP (Good Clinical Practice) and the trial must be implemented scientifically and logically.

The standard operational procedure and the formats of various documents concerning the conduct of trials are given only in Japanese. Please see the Japanese version of the site.