临床试验法规的意外后果。
The unintended consequences of clinical trials regulations.
机构信息
Dental School, Faculty of Medicine, University of Glasgow, Glasgow, Scotland.
出版信息
PLoS Med. 2009 Nov;3(11):e1000131. doi: 10.1371/journal.pmed.1000131. Epub 2009 Nov 17.
Abstract
Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.
摘要
亚历克斯·麦克马洪（Alex McMahon）及其同事对国际协调会议（ICH）关于良好临床规范（GCP）的指导意见提出批评，认为该指导意见正在对欧洲的非商业性随机临床试验产生灾难性影响。
相似文献
1
The unintended consequences of clinical trials regulations.临床试验法规的意外后果。
PLoS Med. 2009 Nov;3(11):e1000131. doi: 10.1371/journal.pmed.1000131. Epub 2009 Nov 17.
2
Confirmatory Trials of Accelerated Approval Drugs - Will Imposing Fines Reduce Delays?加速批准药物的验证性试验——罚款会减少延误吗？
N Engl J Med. 2024 Oct 10;391(14):1273-1275. doi: 10.1056/NEJMp2400699. Epub 2024 Oct 5.
3
4
[Medication prices in Germany--how are they determined?].[德国的药品价格——它们是如何确定的？]
Dtsch Med Wochenschr. 2010 Oct;135(39):p34. doi: 10.1055/s-0030-1247697. Epub 2010 Oct 4.
5
Indian Supreme Court halts approval of new clinical trials until regulatory framework is set up.印度最高法院暂停新临床试验的批准，直至建立监管框架。
BMJ. 2013 Oct 4;347:f5996. doi: 10.1136/bmj.f5996.
6
Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data.缺乏相称性。有七个公共利益的规范，凌驾于有限获取临床数据的上市后商业利益之上。
Trials. 2012 Jul 2;13:100. doi: 10.1186/1745-6215-13-100.
7
[Consequences of the 12th AMG amendment on the conduct of non-commercial clinical trials].[《第12次《药品法》修订案对非商业性临床试验开展的影响》]
Urologe A. 2005 Dec;44(12):1444-8. doi: 10.1007/s00120-005-0944-z.
8
Learning the value of drugs--is rofecoxib a regulatory success story?了解药物的价值——罗非昔布是监管方面的成功案例吗？
N Engl J Med. 2005 Mar 31;352(13):1285-7. doi: 10.1056/NEJMp048358.
9
Status of the GCP guidelines in Europe.欧洲药品临床试验质量管理规范指南的现状。
Methods Find Exp Clin Pharmacol. 1993 May;15(4):223-8.
10
Clinical trials in "emerging markets": regulatory considerations and other factors.“新兴市场”的临床试验：监管考虑因素及其他因素。
Contemp Clin Trials. 2013 Nov;36(2):711-8. doi: 10.1016/j.cct.2013.09.006. Epub 2013 Sep 24.
引用本文的文献
1
The response of Canada's clinical health research ecosystem to the COVID-19 pandemic.加拿大临床卫生研究生态系统对 COVID-19 大流行的反应。
CMAJ. 2024 Jun 16;196(23):E779-E788. doi: 10.1503/cmaj.230760.
2
Activation of Investigator-Initiated Clinical Trials with a Pharmaceutical for Cancer Patients before and after Post-Millennial Changes of Regulations in Germany and Europe.在德国和欧洲千禧年后法规变更前后，一种用于癌症患者的药物的研究者发起的临床试验的启动情况。
Cancers (Basel). 2022 Mar 3;14(5):1308. doi: 10.3390/cancers14051308.
3
Impact of the Clinical Trials Act on Noncommercial Clinical Research in Japan: An Interrupted Time-series Analysis.《临床试验法案对日本非商业性临床研究的影响：一项中断时间序列分析》
J Epidemiol. 2022 Jan 5;32(1):27-33. doi: 10.2188/jea.JE20210051. Epub 2021 Nov 25.
4
Central data monitoring in the multicentre randomised SafeBoosC-III trial - a pragmatic approach.多中心随机对照 SafeBoosC-III 试验中的中心数据监测——一种实用方法。
BMC Med Res Methodol. 2021 Jul 31;21(1):160. doi: 10.1186/s12874-021-01344-4.
5
[Ethics of resuscitation and end of life decisions].[复苏伦理与生命终结决策]
Notf Rett Med. 2021;24(4):720-749. doi: 10.1007/s10049-021-00888-8. Epub 2021 Jun 2.
6
Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review.动态方法在临床试验基于风险监测中的现场级风险持续评估中的应用：范围综述。
Clin Trials. 2021 Apr;18(2):245-259. doi: 10.1177/1740774520976561. Epub 2021 Feb 20.
7
Institutional work to maintain, repair, and improve the regulatory regime: How actors respond to external challenges in the public supervision of ongoing clinical trials in the Netherlands.制度工作以维护、修复和改进监管机制：行为者如何应对荷兰正在进行的临床试验公共监督中的外部挑战。
PLoS One. 2020 Jul 31;15(7):e0236545. doi: 10.1371/journal.pone.0236545. eCollection 2020.
8
Making consent for electronic health and social care data research fit for purpose in the 21st century.使21世纪电子健康与社会护理数据研究的同意书符合目的。
BMJ Health Care Inform. 2020 Jul;27(1). doi: 10.1136/bmjhci-2020-100128.
9
Low-risk trials for children and pregnant women threatened by unnecessary strict regulations. Does the coming EU Clinical Trial Regulation offer a solution?低风险儿童和孕妇临床试验受到不必要的严格规定的威胁。即将出台的欧盟临床试验法规能否提供解决方案？
Eur J Pediatr. 2020 Aug;179(8):1205-1211. doi: 10.1007/s00431-020-03715-3. Epub 2020 Jun 13.
10
Challenges of international oncology trial collaboration-a call to action.国际肿瘤学试验合作的挑战——行动呼吁。
Br J Cancer. 2019 Oct;121(7):515-521. doi: 10.1038/s41416-019-0532-4. Epub 2019 Aug 5.
本文引用的文献
1
Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations.欧盟关于儿科用药和弱势人群临床研究的法规 (EC) No 1901/2006。
Child Adolesc Psychiatry Ment Health. 2008 Dec 8;2(1):37. doi: 10.1186/1753-2000-2-37.
2
Regulation--the real threat to clinical research.监管——对临床研究的真正威胁。
BMJ. 2008 Oct 16;337:a1732. doi: 10.1136/bmj.a1732.
3
Clinical trials in paediatric haematology-oncology: are future successes threatened by the EU directive on the conduct of clinical trials?儿科血液肿瘤学中的临床试验：欧盟关于临床试验实施的指令是否会威胁到未来的成功？
Arch Dis Child. 2007 Nov;92(11):1024-7. doi: 10.1136/adc.2006.103713.
4
The EU's new paediatric medicines legislation: serving children's needs?欧盟新的儿科药品立法：满足儿童需求？
Arch Dis Child. 2007 Sep;92(9):808-11. doi: 10.1136/adc.2006.105692.
5
Clinical Trials Directive slows registration of paediatric studies.《临床试验指令》减缓了儿科研究的注册进程。
Lancet Oncol. 2007 Jan;8(1):10. doi: 10.1016/s1470-2045(06)70991-3.
6
Consequences of Directive 2001/20/EC for investigator-initiated trials in the paediatric population--a field report.2001/20/EC号指令对儿科人群中研究者发起的试验的影响——一份实地报告。
Eur J Pediatr. 2007 Nov;166(11):1169-76. doi: 10.1007/s00431-007-0434-y. Epub 2007 Feb 27.
7
Clinical trials bureaucracy: unintended consequences of well-intentioned policy.临床试验官僚作风：善意政策带来的意外后果。
Clin Trials. 2006;3(6):496-502. doi: 10.1177/1740774506073173.
8
The impact of the 'Clinical Trials' directive on the cost and conduct of non-commercial cancer trials in the UK.“临床试验”指令对英国非商业性癌症试验成本及开展情况的影响。
Eur J Cancer. 2007 Jan;43(1):8-13. doi: 10.1016/j.ejca.2006.09.016. Epub 2006 Nov 21.
9
European move affects academic trials research.欧洲的举措影响学术试验研究。
J Natl Cancer Inst. 2006 Aug 16;98(16):1100-1. doi: 10.1093/jnci/djj349.
10
The clinical trials directive: how is it affecting Europe's noncommercial research?临床试验指令：它对欧洲的非商业性研究有何影响？
PLoS Clin Trials. 2006 Jun;1(2):e13. doi: 10.1371/journal.pctr.0010013.
Zotero 插件