Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic
| Autor: | Xin Li, Bohdana Ratitch, Hale Michael Don, Stefan Englert, Hui Quan, Peng-Liang Zhao, David Wright, Norman Bohidar, Olga Marchenko, Ming Zhou, Marcel Wolbers, Daniel Li, Christine Fletcher, R. Daniel Meyer, Thomas Liu, Wei Shen, Jyotirmoy Dey, Yue Shentu |
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| Rok vydání: | 2020 |
| Předmět: |
Statistics and Probability
medicine.medical_specialty 2019-20 coronavirus outbreak Pandemic Coronavirus disease 2019 (COVID-19) business.industry Special Issue on COVID-19 Missing data Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Estimands COVID-19 Pharmaceutical Science Other Quantitative Biology (q-bio.OT) Quantitative Biology - Other Quantitative Biology Clinical trial Clinical trials FOS: Biological sciences Scale (social sciences) Family medicine Medicine Statistical strategy business Supportive analyses Research Article |
| Zdroj: | Statistics in Biopharmaceutical Research article-version (VoR) Version of Record |
| ISSN: | 1946-6315 |
| DOI: | 10.1080/19466315.2020.1779122 |
| Popis: | 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. Comment: Accepted for publication in Statistics in Biopharmaceutical Research. 40 pages |
| Databáze: | OpenAIRE |
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