Tutorial in biostatistics: data-driven subgroup identification and analysis in clinical trials

Author:

Lipkovich Ilya1,Dmitrienko Alex2,B. Ralph3

Affiliation:

1. Quintiles, Inc.; Durham NC U.S.A.

2. Mediana, Inc.; Overland Park KS U.S.A.

3. Boston University; Boston MA U.S.A.

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference100 articles.

1. Food and Drug Administration. Guidance for industry: enrichment strategies for clinical trials to support approval of human drugs and biological products 2012

2. European Medicines Agency. Guideline on the investigation of subgroups in confirmatory clinical trials 2014

3. General guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials;Dmitrienko;Journal of Biopharmaceutical Statistics,2016

4. A framework for the analysis of heterogeneity of treatment effect in patient-centered outcomes research;Varadhan;Journal of Clinical Epidemiology,2013

5. Survey results on industry practices and challenges in subgroup analysis in clinical trials;Mayer;Statistics in Biopharmaceutical Research,2015

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