The Issues on the Research and Development Strategies of New Drugs

Takeuchi Masahiro

doi:10.4091/iken.15.1_17

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) started from the beginning of 1990. The main purpose of the conference is to consolidate necessary documentations and its formats of new drug application to the regulatory agencies among US, EU and Japan. In 1998 E5 guideline was implemented to extrapolate foreign clinical data to new regions, allowing sponsors to avoid unnecessary clinical trials in new regions. At the same time, a new GCP guideline has implemented to assure quality of foreign clinical trial data. The two new guidelines open the door to conduct small studies, called "bridging studies," in new regions for the extrapolation and conduction of simultaneous global studies. The two types of studies can provide better drugs in a timely fashion.<br>Against the recent trend on the research and development strategies of new drugs, Japanese clinical trial situations are known as "Hollowing out of clinical trials". The phenomenon are due to high costs in conducting clinical trials, slow recruit of patients, and the extrapolation of foreign clinical trial data. This situation expels conduct of bridging studies in Japan and participation in simultaneous global studies. Comparing the situation in conducting clinical trials in Japan, Asia, Europe and the US, we can examine the issues in clinical trials, investigate and incorporate factors to successful bridging and simultaneous global studies. Finally we can consider future issues to cope with among sponsors, academia and regulatory bodies.

The Issues on the Research and Development Strategies of New Drugs

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