Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic-Reference-Cited by-同舟云学术

Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic

Published:2020-07-06 Issue:4 Volume:12 Page:399-411
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Meyer R. Daniel¹,Ratitch Bohdana²,Wolbers Marcel³,Marchenko Olga⁴,Quan Hui⁵,Li Daniel⁶,Fletcher Christine⁷,Li Xin⁸,Wright David⁹,Shentu Yue¹⁰,Englert Stefan¹¹,Shen Wei¹²,Dey Jyotirmoy¹³,Liu Thomas¹⁴,Zhou Ming⁶,Bohidar Norman¹⁵,Zhao Peng-Liang⁵,Hale Michael¹⁶

Affiliation:

1. Pfizer Inc., Groton, CT;

2. Bayer, Montreal, QC, Canada;

3. F. Hoffmann-La Roche Ltd, Basel, Switzerland;

4. Bayer, Whippany, NJ;

5. Sanofi, Bridgewater, NJ;

6. Bristol Myers Squibb, Princeton, NJ;

7. GlaxoSmithKline, Stevenage, Hertfordshire, UK;

8. Genentech/Roche, South San Francisco, CA;

9. AstraZeneca, Cambridge, Cambridgeshire, UK;

10. Merck & Co., Inc., Rahway, NJ;

11. Abbvie Deutschland GmbH & Co KG, Ludwigshafen, Germany;

12. Eli Lilly and Company, Indianapolis, IN;

13. Abbvie Inc., North Chicago, IL;

14. Amgen Inc., Thousand Oaks, CA;

15. Johnson&Johnson, Spring House, PA;

16. Takeda, Cambridge, MA

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2020.1779122

Reference30 articles.

1. Survival Analysis with Interval-Censored Data

2. Estimation of treatment effect under non-proportional hazards and conditionally independent censoring

3. Analysis of Longitudinal Trials with Protocol Deviation: A Framework for Relevant, Accessible Assumptions, and Inference via Multiple Imputation

4. European Medicines Agency Committee for Medicinal Products for Human Use (EMA/CHMP) (2005), “Guideline on Data Monitoring Committees,” available at https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-monitoring-committees_en.pdf.

5. European Medicines Agency Committee for Medicinal Products for Human Use (EMA/CHMP) (2020a), “Guidance to Sponsors on How to Manage Clinical Trials During the COVID-19 Pandemic,” available at https://www.ema.europa.eu/en/documents/press-release/guidance-sponsors-how-manage-clinical-trials-during-covid-19-pandemic_en.pdf.

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