Regional consistency and sample size considerations in a multiregional equivalence trial
| Autor: | Xinji Zhang, Si-Cheng Wu, Jinfang Xu, Jia He, Zhi-Wei Li |
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| Rok vydání: | 2020 |
| Předmět: |
Statistics and Probability
Computer science Consistency criterion Equivalence Trials as Topic 01 natural sciences 010104 statistics & probability 03 medical and health sciences 0302 clinical medicine Econometrics Humans Multicenter Studies as Topic Pharmacology (medical) 030212 general & internal medicine 0101 mathematics Biosimilar Pharmaceuticals Equivalence (measure theory) Pharmacology Models Statistical Comparability Biosimilar Treatment Outcome Clinical Trials Phase III as Topic Therapeutic Equivalency Equivalence Trial Research Design Sample size determination Data Interpretation Statistical Sample Size |
| Zdroj: | Pharmaceutical Statistics. 19:897-908 |
| ISSN: | 1539-1612 1539-1604 |
| DOI: | 10.1002/pst.2044 |
| Popis: | The main objective of a confirmatory multiregional clinical trial (MRCT) is to demonstrate the overall efficacy of test drugs in all participating regions as well as to evaluate the possibility of extrapolating the overall results to each region. With the emergence of the demands of biosimilar drugs development, some guidelines recommended using equivalence design to demonstrate the comparability of efficacy between biosimilar and reference drugs. Previous discussions about assessing regional consistency in MRCT are mainly focused on superiority or non-inferiority designs, while the extensions to equivalence designs were limited. In this work, we proposed a flexible regional consistency criterion for the MRCT with equivalence design. Based on this criterion, sample size determination and sample allocation were also discussed. |
| Databáze: | OpenAIRE |
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