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Health Product Manufacturers and Innovators COVID-19 Impact Assessment: Lessons Learned and Compelling Needs.

作者信息

Mammen Mathai, Narasimhan Vasant, Kuntz Richard, Lewis-Hall Freda, Poul Mojdeh, Schechter Adam

机构信息

Johnson & Johnson.

Novartis.

出版信息

NAM Perspect. 2022 Jan 18;2022. doi: 10.31478/202201b. eCollection 2022.

DOI:10.31478/202201b
PMID:35402857
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8970224/
Abstract
摘要

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Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?受 COVID-19 大流行影响的临床试验:适应性设计能否拯救局面?
Stat Biopharm Res. 2020 Aug 19;12(4):461-477. doi: 10.1080/19466315.2020.1799857.
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Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials.
Stat Biopharm Res. 2020 Aug 17;12(4):419-426. doi: 10.1080/19466315.2020.1788984.
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Under a Black Cloud Glimpsing a Silver Lining: Comment on Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic.乌云之下窥见一线曙光:关于2019冠状病毒病大流行期间开展的临床试验的统计问题及建议的评论
Stat Biopharm Res. 2020 Jul 14;12(4):414-418. doi: 10.1080/19466315.2020.1785931.
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Comment on "Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic".关于《2019冠状病毒病大流行期间开展的临床试验的统计学问题与建议》的评论
Stat Biopharm Res. 2020 Jul 6;12(4):412-413. doi: 10.1080/19466315.2020.1779123.
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Emerging Lessons From COVID-19 for the US Clinical Research Enterprise.COVID-19给美国临床研究事业带来的新教训。
JAMA. 2021 Mar 23;325(12):1159-1161. doi: 10.1001/jama.2021.3284.
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Evaluating SARS-CoV-2 Vaccines After Emergency Use Authorization or Licensing of Initial Candidate Vaccines.在初始候选疫苗获得紧急使用授权或批准上市后评估严重急性呼吸综合征冠状病毒2(SARS-CoV-2)疫苗
JAMA. 2021 Jan 19;325(3):221-222. doi: 10.1001/jama.2020.25127.
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Deferral of Care for Serious Non-COVID-19 Conditions: A Hidden Harm of COVID-19.严重非新冠病情的医疗延迟:新冠疫情的一种潜在危害
JAMA Intern Med. 2021 Feb 1;181(2):274. doi: 10.1001/jamainternmed.2020.4016.
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Racial Disparities in Incidence and Outcomes Among Patients With COVID-19.COVID-19 患者的发病和结局中的种族差异。
JAMA Netw Open. 2020 Sep 1;3(9):e2021892. doi: 10.1001/jamanetworkopen.2020.21892.
10
COVID-19 and readjusting clinical trials.2019冠状病毒病与临床试验的重新调整
Lancet. 2020 Aug 22;396(10250):523-524. doi: 10.1016/S0140-6736(20)31787-6.