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

被引：66

作者：

Meyer, R. Daniel ^{[1
]}

Ratitch, Bohdana ^{[2
]}

Wolbers, Marcel ^{[3
]}

Marchenko, Olga ^{[4
]}

Quan, Hui ^{[5
]}

Li, Daniel ^{[6
]}

Fletcher, Christine ^{[7
]}

Li, Xin ^{[8
]}

Wright, David ^{[9
]}

Shentu, Yue ^{[10
]}

Englert, Stefan ^{[11
]}

Shen, Wei ^{[12
]}

Dey, Jyotirmoy ^{[13
]}

Liu, Thomas ^{[14
]}

Zhou, Ming ^{[6
]}

Bohidar, Norman ^{[15
]}

Zhao, Peng-Liang ^{[5
]}

Hale, Michael ^{[16
]}

机构：

[1] Pfizer Inc, Groton, CT 06340 USA

[2] Bayer, Montreal, PQ, Canada

[3] F Hoffmann La Roche Ltd, Basel, Switzerland

[4] Bayer, Whippany, NJ USA

[5] Sanofi, Bridgewater, NJ USA

[6] Bristol Myers Squibb, Princeton, NJ USA

[7] GlaxoSmithKline, Stevenage, Herts, England

[8] Genentech Roche, San Francisco, CA USA

[9] AstraZeneca, Cambridge, Cambs, England

[10] Merck & Co Inc, Rahway, NJ USA

[11] Abbvie Deutschland GmbH & Co KG, Ludwigshafen, Germany

[12] Eli Lilly & Co, Indianapolis, IN 46285 USA

[13] Abbvie Inc, N Chicago, IL USA

[14] Amgen Inc, Thousand Oaks, CA 91320 USA

[15] Johnson & Johnson, Spring House, PA USA

[16] Takeda, Cambridge, MA USA

来源：

STATISTICS IN BIOPHARMACEUTICAL RESEARCH | 2020年 / 12卷 / 04期

关键词：

Clinical trials; COVID-19; Estimands; Missing data; Pandemic; Statistical strategy; Supportive analyses; INFERENCE; TIME;

D O I：

10.1080/19466315.2020.1779122

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

The COVID-19 pandemic has had and continues to have major impacts on planned and ongoing clinical trials. Its effects on trial data create multiple potential statistical issues. The scale of impact is unprecedented, but when viewed individually, many of the issues are well defined and feasible to address. A number of strategies and recommendations are put forward to assess and address issues related to estimands, missing data, validity and modifications of statistical analysis methods, need for additional analyses, ability to meet objectives and overall trial interpretability.

引用

页码：399 / 411

页数：13

共 30 条

[1] [Anonymous], 1987, Multiple Imputation for Nonresponse in Surveys
[2] [Anonymous], 2010, PREV TREATM MISS DAT
[3] Bogaerts K., 2017, Survival Analysis with IntervalCensored Data: A Practical Approach with Examples in R, SAS, and BUGS
[4] Estimation of treatment effect under non-proportional hazards and conditionally independent censoring
Boyd, Adam P.
Kittelson, John M.
Gillen, Daniel L.
[J]. STATISTICS IN MEDICINE, 2012, 31 (28) : 3504 - 3515
[5] ANALYSIS OF LONGITUDINAL TRIALS WITH PROTOCOL DEVIATION: A FRAMEWORK FOR RELEVANT, ACCESSIBLE ASSUMPTIONS, AND INFERENCE VIA MULTIPLE IMPUTATION
Carpenter, James R.
Roger, James H.
Kenward, Michael G.
[J]. JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2013, 23 (06) : 1352 - 1371
[6] European Medicines Agency Committee for Medicinal Products for Human Use (EMA/CHMP), 2020, GUID SPONS MAN CLIN
[7] European Medicines Agency Committee for Medicinal Products for Human Use (EMA/CHMP), 2020, EMA1583302020
[8] European Medicines Agency Committee for Medicinal Products for Human Use (EMA/CHMP), 2005, GUID DAT MON COMM
[9] Comparison of imputation variance estimators
Hughes, R. A.
Sterne, J. A. C.
Tilling, K.
[J]. STATISTICAL METHODS IN MEDICAL RESEARCH, 2016, 25 (06) : 2541 - 2557
[10] ICH, 2017, GEN PRINC PLANN DES

← 1 2 3 →