title: [Standard Cancer Therapy Are Established by the Investigator-Initiated Post-Marketing Clinical Trials, Not by the Indication-Directed Clinical Trials].
abstract: The financial supports for investigator-initiated post-marketing clinical trial in clinical oncology are reduced after scandals related to the other fields of clinical trials in Japan. These clinical trials are the essential final steps of clinical development in newer cancer therapy, which should be conducted in the investigator-initiated clinical trial groups with well-organized infrastructure and continuous financial supports. The present problems are discussed and summarized. Future perspectives with the national viewpoints needed to be included the idea of "health technology assessment".
authors.affiliation: Dept. of Clinical Oncology, Kochi Health Sciences Center.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D006801:Humans; D008389:Marketing of Health Services; D009369:Neoplasms / Q000188:drug therapy*; D017410:Practice Guidelines as Topic / Q000592:standards
chemical_list: D000970:Antineoplastic Agents