2016
DOI: 10.1177/2168479016651660
|View full text |Cite
|
Sign up to set email alerts
|

Current Practice on Multiplicity Adjustment and Sample Size Calculation in Multi-arm Clinical Trials: An Industry Survey in Japan

Abstract: To adequately design a multi-arm clinical trial, it is important within sample size calculation to consider whether to perform multiplicity adjustment, select MCPs, and define their power.

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
1
1

Citation Types

0
2
0

Year Published

2019
2019
2020
2020

Publication Types

Select...
2

Relationship

0
2

Authors

Journals

citations
Cited by 2 publications
(2 citation statements)
references
References 10 publications
(15 reference statements)
0
2
0
Order By: Relevance
“…Assuming that the primary end point was 7% in the UDCA groups 35 and 18% in the placebo group, 3,36 the minimum sample size necessary to detect a difference with 80% statistical power (α = .05; 2-sided test) was 138 per group (not considering the multiplicity adjustment of α using a fixedsequence method: 600 mg of UDCA vs placebo, and 300 mg of UDCA vs placebo). 37 Efficacy was evaluated by both the full analysis set (FAS, based on the intention-to-treat principle) and the perprotocol set (PPS); FAS findings were interpreted as the main results. The FAS comprised participants who underwent at least 1 evaluation of gallstone formation after randomization and did not violate the inclusion or exclusion criteria.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…Assuming that the primary end point was 7% in the UDCA groups 35 and 18% in the placebo group, 3,36 the minimum sample size necessary to detect a difference with 80% statistical power (α = .05; 2-sided test) was 138 per group (not considering the multiplicity adjustment of α using a fixedsequence method: 600 mg of UDCA vs placebo, and 300 mg of UDCA vs placebo). 37 Efficacy was evaluated by both the full analysis set (FAS, based on the intention-to-treat principle) and the perprotocol set (PPS); FAS findings were interpreted as the main results. The FAS comprised participants who underwent at least 1 evaluation of gallstone formation after randomization and did not violate the inclusion or exclusion criteria.…”
Section: Discussionmentioning
confidence: 99%
“…The study was designed to demonstrate that 300 mg or 600 mg of UDCA was superior to placebo regarding gallstone prevention. Assuming that the primary end point was 7% in the UDCA groups and 18% in the placebo group, the minimum sample size necessary to detect a difference with 80% statistical power (α = .05; 2-sided test) was 138 per group (not considering the multiplicity adjustment of α using a fixed-sequence method: 600 mg of UDCA vs placebo, and 300 mg of UDCA vs placebo) …”
Section: Methodsmentioning
confidence: 99%