Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective.
The multi-regional clinical trials (MRCTs) being administered in different regions of the world now play a major role in providing evidence for the efficacy and safety of new drugs amidst the simultaneous global development and worldwide registration of such drugs, in support of the expeditious availability of medical products to patients. However, such trials present considerable challenges as far as quality, design, implementation, analysis, and interpretation are concerned. In this article, we share our observations and lessons learned from the design, implementation, analysis, and interpretation of some MRCTs with case examples. Current Japanese regulatory guidance on MRCTs is introduced along with some suggestions for design, implementation, and interpretation.
Ando
Yuki
Y
Office of New Drug II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. ando-yuki@pmda.go.jp
Hamasaki
Toshimitsu
T
D004305:Dose-Response Relationship, Drug; D017277:Drug Approval / Q000331:legislation & jurisprudence; D005843:Geography; D017408:Guidelines as Topic; D006801:Humans; D038622:Internationality; D007564:Japan; D015337:Multicenter Studies as Topic / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D004364:Pharmaceutical Preparations; D010599:Pharmacokinetics; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D012107:Research Design
D004364:Pharmaceutical Preparations