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N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17.
2
Reducing Bureaucracy in Clinical Research: A Call for Action.减少临床研究中的官僚作风：行动呼吁。
Hemasphere. 2020 Feb 26;4(2):e352. doi: 10.1097/HS9.0000000000000352. eCollection 2020 Apr.
3
Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018.2009-2018 年新药推向市场所需的研发投资估算。
JAMA. 2020 Mar 3;323(9):844-853. doi: 10.1001/jama.2020.1166.
4
The Magic of Randomization versus the Myth of Real-World Evidence.随机化的魔力与真实世界证据的神话
N Engl J Med. 2020 Feb 13;382(7):674-678. doi: 10.1056/NEJMsb1901642.
5
Bureaucracy is strangling clinical research.官僚主义正在扼杀临床研究。
BMJ. 2019 Mar 13;364:l1097. doi: 10.1136/bmj.l1097.
6
Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016.2015-2016 年美国食品和药物管理局批准的新型治疗药物关键性试验的预估成本。
JAMA Intern Med. 2018 Nov 1;178(11):1451-1457. doi: 10.1001/jamainternmed.2018.3931.
7
Rivaroxaban in Patients with Heart Failure, Sinus Rhythm, and Coronary Disease.利伐沙班治疗心力衰竭伴窦性节律和冠心病患者的疗效。
N Engl J Med. 2018 Oct 4;379(14):1332-1342. doi: 10.1056/NEJMoa1808848. Epub 2018 Aug 27.
8
The impact of data errors on the outcome of randomized clinical trials.数据错误对随机临床试验结果的影响。
Clin Trials. 2017 Oct;14(5):499-506. doi: 10.1177/1740774517716158. Epub 2017 Jun 22.
9
Improving public health by improving clinical trial guidelines and their application.通过改进临床试验指南及其应用来改善公众健康。
Eur Heart J. 2017 Jun 1;38(21):1632-1637. doi: 10.1093/eurheartj/ehx086.
10
Innovation in the pharmaceutical industry: New estimates of R&D costs.制药行业的创新：研发成本的新估计
J Health Econ. 2016 May;47:20-33. doi: 10.1016/j.jhealeco.2016.01.012. Epub 2016 Feb 12.

Good Clinical Trials by removing defensive interpretation of Good Clinical Practice guidelines.

作者信息

den Heijer Jonas M, Heuberger Jules A A C, Hijma Hemme, Kruithof Annelieke C, van Smeden Jeroen, Groeneveld Geert Jan, Burggraaf Jacobus, Cohen Adam

机构信息

Clinical Pharmacology, Centre for Human Drug Research, Leiden, The Netherlands.

Clinical Pharmacology, Leiden University Medical Center, Leiden, The Netherlands.

出版信息

Br J Clin Pharmacol. 2021 Dec;87(12):4552-4559. doi: 10.1111/bcp.14843. Epub 2021 May 3.

DOI:10.1111/bcp.14843
PMID:33939192
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9292589/
Abstract
摘要