title: Benefits of pharmacogenomics in drug development-earlier launch of drugs and less adverse events.
abstract: Currently, pharmaceutical companies are reluctant to introduce pharmacogenomics (PGx) in their practice, since cost-benefit of PGx is obscure and methodology to use PGx in drug development has not been fully established yet. The purpose of this study is to investigate advantages obtained by introducing PGx in clinical trials. Particularly, taking Warfarin as an example, we investigate benefits of Enrichment effect that raises response rate of the drug by PGx. When response rate is raised by only 5%, cost of a clinical trial can be reduced to about 40% of a conventional clinical trial. Furthermore, since period necessary for a trial also can be reduced, development period can be shortened by about 750 days. In summary, PGx enables earlier launch of a drug with less cost, representing benefit to pharmaceutical companies, patients and public as a whole.
authors: Information Center for Medical Science, Tokyo Medical and Dental University, Tokyo, Japan. wohashi@bioinfo.tmd.ac.jp
authors: Wataru
authors: W
authors: Ohashi
authors: Hiroshi
authors: H
authors: Tanaka
mesh_terms: D000925:Anticoagulants / Q000191:economics* / Q000378:metabolism; D002986:Clinical Trials as Topic / Q000191:economics; D003362:Cost-Benefit Analysis; D064420:Drug-Related Side Effects and Adverse Reactions / Q000191:economics* / Q000517:prevention & control; D006801:Humans; D006899:Mixed Function Oxygenases / Q000235:genetics; D010597:Pharmacogenetics / Q000191:economics*; D020641:Polymorphism, Single Nucleotide; D057285:Precision Medicine; D064417:Vitamin K Epoxide Reductases; D014859:Warfarin / Q000191:economics* / Q000378:metabolism
chemical_list: D000925:Anticoagulants; D014859:Warfarin; D006899:Mixed Function Oxygenases; D064417:Vitamin K Epoxide Reductases