A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission

Jiajun Liu, Shein‐Chung Chow

Type: Article

Publication Date: 2022-09-13

Citations: 3

DOI: https://doi.org/10.1007/s43441-022-00459-0

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Therapeutic Innovation & Regulatory Science - View
PubMed - View

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+	Medical Statistics in Drug Development and Regulatory Approval	2024	Bancha Yingngam

Works Cited by This (13)

Action	Title	Year	Authors
+	Clinical Trials for Drug Registrations in Asian-Pacific Countries	2001	Weichung Joe Shih
+	Testing for Qualitative Interactions between Treatment Effects and Patient Subsets	1985	Mitchell H. Gail Richard Simon
+	ASSESSING SENSITIVITY AND SIMILARITY IN BRIDGING STUDIES	2002	Shein‐Chung Chow Jun Shao Oliver Yoa‐Pu Hu
+	Chain Procedures: A Class of Flexible Closed Testing Procedures With Clinical Trial Applications	2011	Brian A. Millen Alex Dmitrienko
+	Reproducibility probability estimation for testing statistical hypotheses	2007	Daniele De Martini
+	Reproducibility probability in clinical trials	2002	Jun Shao Shein‐Chung Chow
+	A comment on replication, <i>P</i>‐values and evidence	1992	Steven N. Goodman
+	General guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials	2015	Alex Dmitrienko Christoph Muysers Arno Fritsch Ilya Lipkovich
+	Bridging Diversity	2010	Shein‐Chung Chow Chin‐Fu Hsiao
+	Multiplicity considerations in subgroup analysis	2017	Alex Dmitrienko Brian A. Millen Ilya Lipkovich