title: Characteristics of pharmacogenomics/biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan.
abstract: Pharmacogenomics (PGx) or biomarker (BM) has the potential to facilitate the development of safer and more effective drugs in terms of their benefit/risk profiles by stratifying population into categories such as responders/non-responders and high-/low-risks to drug-induced serious adverse reactions. In the past decade, practical use of PGx or BM has advanced the field of anti-cancer drug development. To identify the characteristics of the PGx/BM-guided clinical trials for regulatory approval of anti-cancer drugs in Japan, we collected information on design features of 'key trials' in the review reports of anti-cancer drugs that were approved after the implementation of the 'Revised Guideline for the Clinical Evaluation of Anti-cancer drugs' in April 2006. On the basis of the information available on the regulatory review data for the newly approved anti-cancer drugs in Japan, this article aims to explain the limitations and points to consider in the study design of PGx/BM-guided clinical trials.
authors: Pharmaceuticals and Medical Devices Agency (PMDA), Toyko, Japan. ishiguro-akihiro@pmda.go.jp
authors: Akihiro
authors: A
authors: Ishiguro
authors: Satomi
authors: S
authors: Yagi
authors: Yoshiaki
authors: Y
authors: Uyama
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects*; D015415:Biomarkers; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007564:Japan; D007880:Legislation, Drug / Q000592:standards; D009369:Neoplasms / Q000188:drug therapy; D010597:Pharmacogenetics; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors
chemical_list: D000970:Antineoplastic Agents; D015415:Biomarkers