Proposals of statistical consideration to evaluation of results for a specific region in multi-regional trials--Asian perspective.
In recent years, global collaboration has become a conventional strategy for new drug development. To accelerate the development process and to shorten approval time, the design of multi-regional trials incorporates subjects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them. Recently, the trend for simultaneous clinical development in Asian countries being undertaken simultaneously with clinical trials conducted in Europe and the United States has been rapidly rising. In this paper, proposals of statistical consideration to multi-regional trials are provided. More specifically, three aspects are addressed: the definition of the 'Asian region,' the consistency criterion between the 'Asian region' and the overall regions, and the sample size determination for the multi-regional trial.
Tsou
Hsiao-Hui
HH
Division of Biostatistics and Bioinformatics, Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Miaoli County, Taiwan.
Chow
Shein-Chung
SC
Lan
K K Gordon
KK
Liu
Jen-Pei
JP
Wang
Mey
M
Chern
Herng-Der
HD
Ho
Low-Tone
LT
Hsiung
Chao A
CA
Hsiao
Chin-Fu
CF
D001208:Asia; D044466:Asian People / Q000208:ethnology / Q000235:genetics; D018849:Controlled Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D003627:Data Interpretation, Statistical; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational; D005843:Geography / Q000706:statistics & numerical data; D006801:Humans; D038622:Internationality; D015233:Models, Statistical; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data / Q000639:trends; D011110:Polymorphism, Genetic; D012107:Research Design; D018401:Sample Size; D016896:Treatment Outcome
D015507:Drugs, Investigational