A new approach for sizing trials with composite binary endpoints using anticipated marginal values and accounting for the correlation between components-Reference-Cited by-同舟云学术

A new approach for sizing trials with composite binary endpoints using anticipated marginal values and accounting for the correlation between components

Published:2019-01-13 Issue:11 Volume:38 Page:1935-1956
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statistics in Medicine

Author:

Bofill Roig Marta¹^ORCID,Gómez Melis Guadalupe¹^ORCID

Affiliation:

1. Departament d'Estadística i Investigació OperativaUniversitat Politècnica de Catalunya Barcelona Spain

Funder

Generalitat de Catalunya

Ministerio de Economía y Competitividad

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/sim.8092

Reference36 articles.

1. FDA.Multiple Endpoints in Clinical Trials Guidance for Industry.Silver Spring MD:US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research;2017.

2. The Large Pharmaceutical Company Perspective

3. Introduction to sample size determination and power analysis for clinical trials

4. Approaches to sample size estimation in the design of clinical trials—a review

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