Subgroup Analyses in Randomized Clinical Trials: Statistical and Regulatory Issues

Autor:	Jean-Marie Grouin, Maylis Coste, John Lewis
Rok vydání:	2005
Předmět:	Pharmacology Statistics and Probability Models Statistical Multivariate analysis business.industry MEDLINE Data interpretation Subgroup analysis law.invention Clinical trial Randomized controlled trial Sample size determination law Data Interpretation Statistical Sample Size Multivariate Analysis Econometrics Medicine Pharmacology (medical) business Randomized Controlled Trials as Topic Clinical psychology
Zdroj:	Journal of Biopharmaceutical Statistics. 15:869-882
ISSN:	1520-5711 1054-3406
Popis:	Recently, two CPMP Points to Consider, one on adjustment for baseline covariates and the other on multiplicity issues in clinical trials, have included recommendations on the use of subgroup analysis for regulatory purposes. However, despite their regular use and regulatory attention, the validity and nature of subgroup analyses are still frequently questioned. This article provides guidance on when subgroup analyses can be done, when they should be done, and their interpretation. The validity of common regulatory claims based on subgroup analyses is then discussed.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1bf2854fa4dd3ac92029c476f258aadf https://doi.org/10.1081/bip-200067988 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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