E L Trimble1, J Ledermann2, K Law3, T Miyata4, C K Imamura5, B-H Nam6, Y H Kim7, Y-J Bang8, M Michaels9, D Ardron10, S Amano11, Y Ando12, T Tominaga12, K Kurokawa13, N Takebe14. 1. Department of Health and Human Services, National Cancer Institute, National Institutes of Health, Rockville, USA. 2. UCL and UCL Hospitals Comprehensive Biomedical Research Centre, University College of London, London. 3. Cancer Research UK, London, UK. 4. Research and Development Division, Health Policy Bureau, Ministry of Heath, Labour, and Welfare, Government of Japan, Tokyo. 5. Department of Clinical Pharmacokinetics and Pharmacodynamics, School of Medicine, Keio University, Tokyo, Japan. 6. Clinical Research Coordination Center, Biometric Research Branch, National Cancer Center, Geonggi-do. 7. Department of Internal Medicine, Korea University College of Medicine, Seoul. 8. Seoul National University College of Medicine, Seoul, Republic of Korea. 9. Education Network to Advance Clinical Trials (ENACCT), Bethesda, USA. 10. National Cancer Research Institute Consumer Liaison Group, University of Leeds, Leeds, UK. 11. Group NEXUS Japan, Tokyo. 12. Pharmaceuticals and Medical Devices Agencies (PMDA), Tokyo. 13. Health and Global Policy Institute, Tokyo, Japan. 14. Department of Health and Human Services, National Cancer Institute, National Institutes of Health, Rockville, USA. Electronic address: takeben@mail.nih.gov.
Abstract
BACKGROUND: Academic/institutional investigator-initiated clinical trials benefit individuals and society by supplementing gaps in industry-sponsored clinical trials. MATERIALS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: Academic/institutional investigator-initiated clinical trials benefit individuals and society by supplementing gaps in industry-sponsored clinical trials. MATERIALS: 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. RESULTS: 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. CONCLUSIONS: To maximize the effectiveness of these trials, a policy to educate health care professionals, cancerpatients 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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