Current Status and Future Prospects of Post-Marketing Clinical Trials / 薬剤疫学

ABSTRACT

Good Post-Marketing Surveillance Practice (GPMSP) defines “post-marketing clinical trials” as industry-initiated studies constituting a part of Post-Marketing Surveillance (PMS). Post-marketing clinical studies play the role of gathering further information on appropriate drug use. This is why the proper conduct of medically required post-marketing clinical trials would facilitate the proposal of new treatments with improved efficacy and/or safety over existing therapies, thereby contributing to the promotion of EBM and to the advance of healthcare. In the case of anticancer drugs, in particular, post-marketing clinical trials are of great importance, because they also serve as Phase III studies. In reality, however, pharmaceutical companies are not very active in conducting these studies because of the many issues involved. To solve or alleviate these problems, the Japan Pharmaceutical Manufacturers Association and COTEC are making aggressive efforts.