Blinded sample size reestimation for negative binomial regression with baseline adjustment

Author:

Zapf Antonia12ORCID,Asendorf Thomas1ORCID,Anten Christoph1ORCID,Mütze Tobias13ORCID,Friede Tim1ORCID

Affiliation:

1. Department of Medical Statistics University Medical Center Göttingen Göttingen Germany

2. Department of Medical Biometry and Epidemiology University Medical Center Hamburg‐Eppendorf Hamburg Germany

3. Statistical Methodology Novartis Pharma AG Basel Switzerland

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference47 articles.

1. Which clinical studies provide the best evidence?

2. European Medicines Agency (EMA). Guideline on adjustment for baseline covariates in clinical trials.https://www.ema.europa.eu/documents/scientific‐guideline/guideline‐adjustment‐baseline‐covariates‐clinical‐trials_en.pdf. Accessed February 01 2020; Published September 2015.

3. Covariate adjustment in randomized controlled trials with dichotomous outcomes increases statistical power and reduces sample size requirements

4. Repeated measures in clinical trials: Analysis using mean summary statistics and its implications for design

5. A practical approach to computing power for generalized linear models with nominal, count, or ordinal responses

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