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Evaluation of Compliance With Legal Requirements Under the FDA Amendments Act of 2007 for Timely Registration of Clinical Trials, Data Verification, Delayed Reporting, and Trial Document Submission.评价 2007 年 FDA 修正案中对临床试验及时注册、数据验证、延迟报告和试验文件提交的合规性。
JAMA Intern Med. 2021 Aug 1;181(8):1128-1130. doi: 10.1001/jamainternmed.2021.2036.
2
Trends in COVID-19 therapeutic clinical trials.COVID-19治疗性临床试验的趋势。
Nat Rev Drug Discov. 2021 Apr;20(4):254-255. doi: 10.1038/d41573-021-00037-3.
3
10-Year Update on Study Results Submitted to ClinicalTrials.gov.提交至ClinicalTrials.gov的研究结果的10年更新
N Engl J Med. 2019 Nov 14;381(20):1966-1974. doi: 10.1056/NEJMsr1907644.
4
The evolution of trial registries and their use to assess the clinical trial enterprise.试验注册库的发展及其在评估临床试验事业中的应用。
JAMA. 2012 May 2;307(17):1861-4. doi: 10.1001/jama.2012.4230.
5
The ClinicalTrials.gov results database--update and key issues.ClinicalTrials.gov 结果数据库——更新及主要问题。
N Engl J Med. 2011 Mar 3;364(9):852-60. doi: 10.1056/NEJMsa1012065.

The importance of ClinicalTrials.gov in informing trial design, conduct, and results.

作者信息

Califf Robert M, Cutler Tracy L, Marston Hilary D, Meeker-O'Connell Ann

机构信息

Department of Medicine, Duke University School of Medicine, Durham, NC, USA.

U.S. Food and Drug Administration, Silver Spring, MD, USA.

出版信息

J Clin Transl Sci. 2025 Feb 25;9(1):e42. doi: 10.1017/cts.2025.9. eCollection 2025.

DOI:10.1017/cts.2025.9
PMID:40201648
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11975776/
Abstract
摘要