开放标签扩展研究：是研究还是营销？
Open label extension studies: research or marketing?
作者信息
Taylor G J, Wainwright P
机构信息
Research and Development Support Unit, School for Health, University of Bath, Bath BA1 3NG.
出版信息
BMJ. 2005 Sep 10;331(7516):572-4. doi: 10.1136/bmj.331.7516.572.
Abstract
Open label extension studies allow continued prescribing of unlicensed drugs after a randomised trial, but it is unclear whether patients or drug companies are benefiting the most
摘要
开放标签扩展研究允许在随机试验后继续使用未获许可的药物进行处方，但尚不清楚患者或制药公司谁受益最大。
相似文献
1
Open label extension studies: research or marketing?开放标签扩展研究：是研究还是营销？
BMJ. 2005 Sep 10;331(7516):572-4. doi: 10.1136/bmj.331.7516.572.
2
Does research ethics rest on a mistake?研究伦理是否基于一个错误？
Am J Bioeth. 2005 Winter;5(1):34-6; author reply W15-8. doi: 10.1080/15265160590927705.
3
Vulnerability from a global medicine perspective.从全球医学视角看脆弱性。
Am J Bioeth. 2004 Summer;4(3):62-3; discussion W32. doi: 10.1080/15265160490497146.
4
Ethical considerations in research studies.研究中的伦理考量。
Medsurg Nurs. 2014 Jan-Feb;23(1):54-5.
5
Military medical ethics: a review of the literature and a call to arms.军事医学伦理学：文献综述与战斗号召
Camb Q Healthc Ethics. 2013 Jan;22(1):92-109. doi: 10.1017/S0963180112000424.
6
Ethics and research in long-term care: a position statement from the American Medical Directors Association.长期护理中的伦理与研究：美国医学主任协会的立场声明
J Am Med Dir Assoc. 2003 May-Jun;4(3):171-4. doi: 10.1097/01.JAM.0000064460.31818.80.
7
Reconciling protection with scientific progress.协调保护与科学进步的关系。
Hastings Cent Rep. 2005 Sep-Oct;35(5):3. doi: 10.1353/hcr.2005.0082.
8
Social restrictions on informed consent: research ethics and medical decision making.知情同意的社会限制：研究伦理与医疗决策
HEC Forum. 2004 Mar;16(1):38-44. doi: 10.1023/b:hecf.0000031778.43876.28.
9
When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?医生-研究者何时从自己的患者那里寻求同意是合乎道德的？
Am J Bioeth. 2019 Apr;19(4):11-18. doi: 10.1080/15265161.2019.1572811.
10
The history and moral foundations of human-subject research.人体研究的历史与道德基础。
Am J Phys Med Rehabil. 2007 Feb;86(2):82-5. doi: 10.1097/PHM.0b013e31802f00cd.
引用本文的文献
1
Development and emerging trends of drug resistance mutations in HIV: a bibliometric analysis based on CiteSpace.HIV耐药性突变的发展与新趋势：基于CiteSpace的文献计量分析
Front Microbiol. 2024 May 15;15:1374582. doi: 10.3389/fmicb.2024.1374582. eCollection 2024.
2
Early access programs for medicines: comparative analysis among France, Italy, Spain, and UK and focus on the Italian case.药品早期准入计划：法国、意大利、西班牙和英国的比较分析及对意大利案例的关注
J Pharm Policy Pract. 2023 May 17;16(1):67. doi: 10.1186/s40545-023-00570-z.
3
The attitude of patients with progressive ataxias towards clinical trials.进展性共济失调患者对临床试验的态度。
Orphanet J Rare Dis. 2022 Jan 4;17(1):1. doi: 10.1186/s13023-021-02091-x.
4
Efficacy of Afatinib in the Treatment of Patients with Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis.阿法替尼治疗非小细胞肺癌和头颈部鳞状细胞癌患者的疗效：一项系统评价和荟萃分析。
Cancers (Basel). 2021 Feb 8;13(4):688. doi: 10.3390/cancers13040688.
5
Posttrial Access to Medical Interventions: Intricacies, Challenges, and Solutions.试验后医疗干预措施的获取：复杂性、挑战与解决方案。
Int J Appl Basic Med Res. 2019 Jan-Mar;9(1):3-8. doi: 10.4103/ijabmr.IJABMR_218_18.
6
Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.向美国食品和药物管理局提交的儿科临床试验持续时间。
JAMA Pediatr. 2019 Jan 1;173(1):60-67. doi: 10.1001/jamapediatrics.2018.3227.
7
Discontinuation of non-anti-TNF drugs for rheumatoid arthritis in interventional versus observational studies: a systematic review and meta-analysis.类风湿关节炎非肿瘤坏死因子（TNF）药物在干预性研究与观察性研究中的停药情况：一项系统评价与荟萃分析
Eur J Clin Pharmacol. 2018 Nov;74(11):1513-1521. doi: 10.1007/s00228-018-2524-3. Epub 2018 Jul 18.
8
Human dignity as a basis for providing post-trial access to healthcare for research participants: a South African perspective.将人类尊严作为为研究参与者提供审判后医疗保健服务的基础：南非视角。
Med Health Care Philos. 2018 Mar;21(1):139-155. doi: 10.1007/s11019-017-9782-1.
9
Why calpain inhibitors are interesting leading compounds to search for new therapeutic options to treat leishmaniasis?为什么钙蛋白酶抑制剂是寻找治疗利什曼病新治疗方案的有趣先导化合物？
Parasitology. 2017 Feb;144(2):117-123. doi: 10.1017/S003118201600189X. Epub 2016 Nov 21.
10
Expanded Access Programme: looking for a common definition.扩大使用计划：寻求一个通用定义。
Trials. 2016 Jan 12;17:21. doi: 10.1186/s13063-015-1108-0.
本文引用的文献
1
Can keeping clinical trial participants blind to their study treatment adversely affect subsequent care?让临床试验参与者对其研究治疗不知情会对后续护理产生不利影响吗？
Contemp Clin Trials. 2005 Jun;26(3):290-9. doi: 10.1016/j.cct.2005.01.003. Epub 2005 Mar 3.
2
International ethical guidelines for biomedical research involving human subjects.涉及人类受试者的生物医学研究国际伦理准则。
Bull Med Ethics. 2002 Oct(182):17-23.
3
Consent to open label extension studies: some ethical issues.开放标签扩展研究的同意：一些伦理问题。
J Med Ethics. 2002 Dec;28(6):373-6. doi: 10.1136/jme.28.6.373.
4
The ethical problems of the open label extension study.开放标签扩展研究的伦理问题。
Camb Q Healthc Ethics. 1996 Summer;5(3):410-4. doi: 10.1017/s0963180100007210.
Zotero 插件