title: International models of investigator-initiated trials: implications for Japan.
abstract: BACKGROUND
  Academic/institutional investigator-initiated clinical trials benefit individuals and society by supplementing gaps in industry-sponsored clinical trials.
  
  
  METHODS
  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.
authors: Department of Health and Human Services, National Cancer Institute, National Institutes of Health, Rockville, USA.
authors: E L
authors: EL
authors: Trimble
authors: UCL and UCL Hospitals Comprehensive Biomedical Research Centre, University College of London, London.
authors: J
authors: J
authors: Ledermann
authors: Cancer Research UK, London, UK.
authors: K
authors: K
authors: Law
authors: Research and Development Division, Health Policy Bureau, Ministry of Heath, Labour, and Welfare, Government of Japan, Tokyo.
authors: T
authors: T
authors: Miyata
authors: Department of Clinical Pharmacokinetics and Pharmacodynamics, School of Medicine, Keio University, Tokyo, Japan.
authors: C K
authors: CK
authors: Imamura
authors: Clinical Research Coordination Center, Biometric Research Branch, National Cancer Center, Geonggi-do.
authors: B-H
authors: BH
authors: Nam
authors: Department of Internal Medicine, Korea University College of Medicine, Seoul.
authors: Y H
authors: YH
authors: Kim
authors: Seoul National University College of Medicine, Seoul, Republic of Korea.
authors: Y-J
authors: YJ
authors: Bang
authors: Education Network to Advance Clinical Trials (ENACCT), Bethesda, USA.
authors: M
authors: M
authors: Michaels
authors: National Cancer Research Institute Consumer Liaison Group, University of Leeds, Leeds, UK.
authors: D
authors: D
authors: Ardron
authors: Group NEXUS Japan, Tokyo.
authors: S
authors: S
authors: Amano
authors: Pharmaceuticals and Medical Devices Agencies (PMDA), Tokyo.
authors: Y
authors: Y
authors: Ando
authors: Pharmaceuticals and Medical Devices Agencies (PMDA), Tokyo.
authors: T
authors: T
authors: Tominaga
authors: Health and Global Policy Institute, Tokyo, Japan.
authors: K
authors: K
authors: Kurokawa
authors: Department of Health and Human Services, National Cancer Institute, National Institutes of Health, Rockville, USA. Electronic address: takeben@mail.nih.gov.
authors: N
authors: N
authors: Takebe
mesh_terms: D000970:Antineoplastic Agents; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval; D055808:Drug Discovery; D006801:Humans; D007564:Japan; D057766:Policy; D012108:Research Personnel
chemical_list: D000970:Antineoplastic Agents