TY - JOUR
T1 - Benefits of pharmacogenomics in drug development-earlier launch of drugs and less adverse events
AU - Ohashi, Wataru
AU - Tanaka, Hiroshi
PY - 2010/8/1
Y1 - 2010/8/1
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Cost-effective
KW - Personalized medicines
KW - Pharmacogenomics
KW - SNPs
KW - Warfarin
UR - http://www.scopus.com/inward/record.url?scp=77956056999&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77956056999&partnerID=8YFLogxK
U2 - 10.1007/s10916-009-9284-7
DO - 10.1007/s10916-009-9284-7
M3 - Article
C2 - 20703925
AN - SCOPUS:77956056999
VL - 34
SP - 701
EP - 707
JO - Journal of Medical Systems
JF - Journal of Medical Systems
SN - 0148-5598
IS - 4
ER -