A Phase 3 Trial Analysis Proposal for Mitigating the Impact of the COVID-19 Pandemic-Reference-Cited by-同舟云学术

A Phase 3 Trial Analysis Proposal for Mitigating the Impact of the COVID-19 Pandemic

Published:2021-04-28 Issue:1 Volume:14 Page:80-86
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Hua Eva¹,Janocha Reinhold²,Severin Thomas²,Wei Jiawei¹,Vandemeulebroecke Marc³

Affiliation:

1. Biostatistical Sciences and Pharmacometrics, China Novartis Institutes for Biomedical Research Co., Shanghai, China

2. Global Drug Development, Novartis Pharma AG, Basel, Switzerland

3. Biostatistical Sciences and Pharmacometrics, Novartis Pharma AG, Basel, Switzerland

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2021.1905056

Reference13 articles.

1. Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials

2. A graphical approach to sequentially rejective multiple test procedures

3. Replicability, Reproducibility, and Multiplicity in Drug Development

4. European Medicines Agency Committee for Medicinal Products for Human Use. (EMA/CHMP). (2020), “Points to Consider on Implications of Coronavirus Disease. (COVID-19) on Methodological Aspects of Ongoing Clinical Trials,” EMA/158330/2020 Rev. 1. Available at https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical_en-0.pdf.

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