A comparison of semiparametric approaches to evaluate composite endpoints in heart failure trials

Author:

Toenges Gerrit1ORCID,Mütze Tobias2ORCID,Jahn‐Eimermacher Antje3

Affiliation:

1. Institute of Medical Biostatistics, Epidemiology and Informatics University Medical Center of the Johannes Gutenberg University Mainz Mainz Germany

2. Statistical Methodology Novartis Pharma AG Basel Switzerland

3. Department of Mathematics and Natural Sciences Darmstadt University of Applied Sciences Darmstadt Germany

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference46 articles.

1. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

2. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document

3. Development and Evolution of a Hierarchical Clinical Composite End Point for the Evaluation of Drugs and Devices for Acute and Chronic Heart Failure

4. EMA's Committee for Medicinal Products for Human Use (CHMP) Guideline on multiplicity issues in clinical trials;2017.https://www.ema.europa.eu/en/documents/scientific‐guideline/draft‐guide%line‐multiplicity‐issues‐clinical‐trials_en.pdf. Accessed June 23 2020.

5. FDA's Office of Translational Sciences in the Center for Drug Evaluation and Research. Multiple Endpoints in Clinical Trials ‐ Guidance for Industry;2017.https://www.fda.gov/media/102657/download. Accessed June 23 2020.

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