TY - JOUR
T1 - Identification of the minimum non-inferior dose in a three-arm non-inferiority trial
AU - Zhong, Junjiang
AU - Wen, Miin Jye
AU - Cheung, Siu Hung
N1 - Funding Information:
We are grateful to the referees who provided very helpful suggestions and comments. Zhong’s research was supported by the Natural Science Foundation of Fujian Province, China (2018J01430) and a research grant from Xiamen University of Technology, China (YKJ17003R). Wen’s research was supported by the Ministry of Science and Technology, Taiwan, MOST 108-2118-M-006-008, and MOST 107-2118-M-006-005. Cheung’s research was supported by the Research Grants Council of the Hong Kong Special Administrative Region (CUHK14304916) and a direct grant from The Chinese University of Hong Kong.
Publisher Copyright:
© 2020, Korean Statistical Society.
PY - 2020/12
Y1 - 2020/12
N2 - Non-inferiority (NI) trials have gained recognition as an effective tool with which to search for substitutes for a standard treatment that is associated with certain undesirable features, such as adverse side-effects, an exorbitant cost, or an extremely complicated therapeutic regimen. Statistical methods have been developed for NI studies with multiple experimental treatments. However, experimental treatments sometimes represent a new treatment with various dose levels, and in such circumstances, identification of the minimum non-inferior dose is a reasonable objective of the trial. Thus, we examine several potential testing procedures with respect to this testing objective. A simulation study is conducted to evaluate their performance, and determination of the sample size is discussed. Two clinical examples are provided to illustrate the proposed method.
AB - Non-inferiority (NI) trials have gained recognition as an effective tool with which to search for substitutes for a standard treatment that is associated with certain undesirable features, such as adverse side-effects, an exorbitant cost, or an extremely complicated therapeutic regimen. Statistical methods have been developed for NI studies with multiple experimental treatments. However, experimental treatments sometimes represent a new treatment with various dose levels, and in such circumstances, identification of the minimum non-inferior dose is a reasonable objective of the trial. Thus, we examine several potential testing procedures with respect to this testing objective. A simulation study is conducted to evaluate their performance, and determination of the sample size is discussed. Two clinical examples are provided to illustrate the proposed method.
UR - http://www.scopus.com/inward/record.url?scp=85080932366&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85080932366&partnerID=8YFLogxK
U2 - 10.1007/s42952-020-00053-w
DO - 10.1007/s42952-020-00053-w
M3 - Article
AN - SCOPUS:85080932366
SN - 1226-3192
VL - 49
SP - 1238
EP - 1254
JO - Journal of the Korean Statistical Society
JF - Journal of the Korean Statistical Society
IS - 4
ER -