Improving sample size recalculation in adaptive clinical trials by resampling-Reference-Cited by-同舟云学术

Improving sample size recalculation in adaptive clinical trials by resampling

Published:2021-04 Issue:6 Volume:20 Page:1035-1050
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Herrmann Carolin¹^ORCID,Kluge Corinna¹,Pilz Maximilian²^ORCID,Kieser Meinhard²^ORCID,Rauch Geraldine¹^ORCID

Affiliation:

1. Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt‐Universität zu Berlin Institute of Biometry and Clinical Epidemiology, Charitéplatz 1, 10117 Berlin Germany

2. Institute of Medical Biometry and Informatics University Medical Center Ruprechts‐Karls University Heidelberg Heidelberg Germany

Funder

Deutsche Forschungsgemeinschaft

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2122

Reference30 articles.

1. U.S. Department of Health and Human Services Food and Drug Administration.Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry.2019.https://www.fda.gov/media/78495/download

2. Committee for Medicinal Products for Human Use European Medicines Agency.Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design.London:EMEA.2007.https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-methodological-issues-confirmatory-clinical-trials-planned-adaptive-design_en.pdf

3. Twenty‐five years of confirmatory adaptive designs: opportunities and pitfalls

4. Designed Extension of Studies Based on Conditional Power

5. Adaptive Sample Size Calculations in Group Sequential Trials