S-Space College of Medicine/School of Medicine (의과대학/대학원) Internal Medicine (내과학전공) Journal Papers (저널논문_내과학전공)
International models of investigator-initiated trials: implications for Japan
- Trimble, E. L.; Ledermann, J.; Law, K.; Miyata, T.; Imamura, C. K.; Nam, B. -H.; Kim, Y. H.; Bang, Yung-Jue; Michaels, M.; Ardron, D.; Amano, S.; Ando, Y.; Tominaga, T.; Kurokawa, K.; Takebe, N.
- Issue Date
- Annals of Oncology, Vol.23 No.12, pp.3151-3155
- academic; institutional investigator-initiated clinical trials; anticancer drugs; good clinical practice; health care policy; international clinical trials; patient advocates
- Academic/institutional investigator-initiated clinical trials benefit individuals and society by supplementing gaps in industry-sponsored clinical trials. In May 2010, experts from Japan, the Republic of Korea, the UK, and the United States, met at a symposium in Tokyo, Japan, to discuss how policies related to the conduct of clinical trials, which have been shown to be effective, may be applied to other regions of the world. In order to increase the availability of anticancer drugs world-wide, nations including Japan should examine the benefits of increasing the number of investigator-initiated clinical trials. These trials represent one of the most effective ways to translate basic scientific knowledge into clinical practice. These trials should be conducted under GCP guidelines and include Investigational New Drug application submissions with the ultimate goal of future drug approval. To maximize the effectiveness of these trials, a policy to educate health care professionals, cancer patients and their families, and the public in general on the benefits of clinical trials should be strengthened. Finally, policies that expedite the clinical development of novel cancer drugs which have already been shown to be effective in other countries are needed in many nations including Japan to accelerate drug approval.
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