临床试验中记录事件的理由。
The case for recording events in clinical trials.
作者信息
Skegg D C, Doll R
出版信息
Br Med J. 1977 Dec 10;2(6101):1523-4. doi: 10.1136/bmj.2.6101.1523.
Abstract
The value of clinical trials in detecting unwanted effects of new medicines would be enhanced if doctors recorded all adverse events experienced by patients and not just those regarded as adverse reactions to drugs. All events should be reported to the centre co-ordinating the trial and analysed in treated patients and controls. This method might have revealed the ocular toxicity of practolol before the drug was marketed in 1970.
摘要
如果医生记录患者经历的所有不良事件，而不仅仅是那些被视为药物不良反应的事件，那么临床试验在检测新药不良影响方面的价值将会提高。所有事件都应报告给协调试验的中心，并在治疗组患者和对照组中进行分析。这种方法可能在1970年心得宁上市之前就揭示其眼部毒性。
相似文献
1
The case for recording events in clinical trials.临床试验中记录事件的理由。
Br Med J. 1977 Dec 10;2(6101):1523-4. doi: 10.1136/bmj.2.6101.1523.
2
Postmarketing surveillance of adverse drug reactions in general practice. I: search for new methods.全科医疗中药物不良反应的上市后监测。I：探寻新方法。
Br Med J (Clin Res Ed). 1981 Apr 4;282(6270):1131-2. doi: 10.1136/bmj.282.6270.1131.
3
Design, monitoring, and analysis issues relative to adverse events.
Drug Inf J. 1987;21(1):21-8. doi: 10.1177/009286158702100105.
4
New strategies for drug monitoring.药物监测的新策略。
Br Med J. 1977 Apr 2;1(6065):861-2.
5
Basic strategy for avoiding drug interaction during stage of drug development; proposals relative to planning of non-clinical and clinical studies and how clinical trials should be planned.
J Toxicol Sci. 1996 Dec;21(5):331-9. doi: 10.2131/jts.21.5_331.
6
Evaluation of methods for recording adverse drug reactions in clinical trials.评估临床试验中药物不良反应的记录方法。
Eur J Clin Microbiol Infect Dis. 1990 Jul;9(7):534-6. doi: 10.1007/BF01964298.
7
Data on drugs and adverse experiences: moving from the specific to the general.
Drug Inf J. 1987;21(1):39-46. doi: 10.1177/009286158702100107.
8
Post-marketing surveillance of adverse reactions to new medicines.新药不良反应的上市后监测
Br Med J. 1977 Oct 15;2(6093):1001-3. doi: 10.1136/bmj.2.6093.1001.
9
Postulates for the evaluation of adverse reactions to drugs.
Clin Infect Dis. 1995 Jan;20(1):179-82. doi: 10.1093/clinids/20.1.179.
10
Practical problems in the organization of a drug trial in two hospital groups.在两个医院集团中组织药物试验的实际问题。
Gerontol Clin (Basel). 1974;16(1):100-4. doi: 10.1159/000245491.
引用本文的文献
1
Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study.致力于就单纯性疟疾临床药物研究中获取参与者报告的安全性数据所使用的方法达成共识：一项德尔菲技术研究。
Malar J. 2017 Jan 28;16(1):52. doi: 10.1186/s12936-017-1699-x.
2
Monitoring adverse drug reactions: a preliminary study.监测药物不良反应：初步研究。
Can Fam Physician. 1981 Aug;27:1235-8.
3
A survey of adverse drug reactions in family practice.家庭医疗中的药物不良反应调查。
Can Fam Physician. 1984 Jan;30:81-4.
4
Benefits and harms of drug treatments.药物治疗的益处与危害。
BMJ. 2004 Jul 3;329(7456):2-3. doi: 10.1136/bmj.329.7456.2.
5
Synthesising licensing data to assess drug safety.综合许可数据以评估药物安全性。
BMJ. 2004 Feb 28;328(7438):518-20. doi: 10.1136/bmj.328.7438.518.
6
The incidence of adverse events and risk factors for upper gastrointestinal disorders associated with meloxicam use amongst 19,087 patients in general practice in England: cohort study.英格兰全科医疗中19087例使用美洛昔康患者的不良事件发生率及上消化道疾病相关风险因素：队列研究
Br J Clin Pharmacol. 2000 Jul;50(1):35-42. doi: 10.1046/j.1365-2125.2000.00229.x.
7
A prospective study of adverse drug reactions in hospitalized children.一项关于住院儿童药物不良反应的前瞻性研究。
Br J Clin Pharmacol. 1999 Jun;47(6):681-8. doi: 10.1046/j.1365-2125.1999.00943.x.
8
Pharmacovigilance in the pharmaceutical industry.制药行业中的药物警戒
Br J Clin Pharmacol. 1998 May;45(5):427-31. doi: 10.1046/j.1365-2125.1998.00713.x.
9
The way towards adverse event monitoring in clinical trials.临床试验中不良事件监测的方法。
Drug Saf. 1993 Mar;8(3):251-62. doi: 10.2165/00002018-199308030-00006.
10
Ethically optimised designs.符合伦理道德的优化设计。
Br J Clin Pharmacol. 1982 Apr;13(4):469-80. doi: 10.1111/j.1365-2125.1982.tb01407.x.
本文引用的文献
1
THE DESIGN AND LOGIC OF A MONITOR OF DRUG USE.药物使用监测仪的设计与逻辑
J Chronic Dis. 1965 Jan;18:77-98. doi: 10.1016/0021-9681(65)90054-8.
2
Comprehensive drug surveillance.全面的药物监测。
JAMA. 1970 Aug 31;213(9):1455-60.
3
Measurement of side effects of drugs.药物副作用的测量
Br Med J. 1974 Jun 29;2(5921):698-9. doi: 10.1136/bmj.2.5921.698.
4
Side effects of hypotensive agents evaluated by a self-administered questionnaire.通过自行填写问卷评估降压药的副作用。
Br Med J. 1973 Sep 1;3(5878):485-90. doi: 10.1136/bmj.3.5878.485.
5
Adverse drug reactions-a matter of opinion.药物不良反应——一个见仁见智的问题。
Clin Pharmacol Ther. 1976 May;19(5 Pt 1):489-92. doi: 10.1002/cpt1976195part1489.
6
Clinical trials of new drugs.新药临床试验。
J R Coll Physicians Lond. 1977 Apr;11(3):226-33.
7
Frequency of eye complaints and rashes among patients receiving practolol and propranolol.接受心得宁和普萘洛尔治疗的患者眼部不适和皮疹的发生率。
Lancet. 1977 Sep 3;2(8036):475-8. doi: 10.1016/s0140-6736(77)91602-6.
Zotero 插件