Cautionary note on regional consistency evaluation in multiregional clinical trials with binary outcomes

Multiregional clinical trials (MRCTs) have become increasingly common during the development of new drugs to obtain simultaneous drug approvals worldwide. When planning MRCTs, a major statistical challenge is determination of the regional sample size. In general, the regional sample size must be det...

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Veröffentlicht in:	Pharmaceutical statistics : the journal of the pharmaceutical industry 2024-05, Vol.23 (3), p.385-398
1. Verfasser:	Homma, Gosuke
Format:	Artikel
Sprache:	eng
Schlagworte:	binary outcomes Carcinoma, Renal Cell - drug therapy Clinical trials Clinical Trials as Topic - methods Clinical Trials as Topic - statistics & numerical data Computer Simulation conditional probability consistency Data Interpretation, Statistical Drug Approval - methods exact formula Humans Japan Kidney Neoplasms - drug therapy Models, Statistical Multicenter Studies as Topic - methods multiregional clinical trials Probability Research Design - statistics & numerical data Sample Size unconditional probability
Online-Zugang:	Volltext
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