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The Case for Recording Events in Clinical Trials

Overview
Journal Br Med J
Specialty General Medicine
Date 1977 Dec 10
PMID 338116
Citations 19
Authors
D C Skegg
R DOLL
Affiliations
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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.

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References
1.
FINNEY D . THE DESIGN AND LOGIC OF A MONITOR OF DRUG USE. J Chronic Dis. 1965; 18:77-98. DOI: 10.1016/0021-9681(65)90054-8. View
2.
Skegg D, DOLL R . Frequency of eye complaints and rashes among patients receiving practolol and propranolol. Lancet. 1977; 2(8036):475-8. DOI: 10.1016/s0140-6736(77)91602-6. View
3.
Dollery C . Clinical trials of new drugs. J R Coll Physicians Lond. 1977; 11(3):226-33. PMC: 5368730. View
4.
Karch F, Smith C, Kerzner B, Mazzullo J, Weintraub M, Lasagna L . Adverse drug reactions-a matter of opinion. Clin Pharmacol Ther. 1976; 19(5 Pt 1):489-92. DOI: 10.1002/cpt1976195part1489. View
5.
Huskisson E, Wojtulewski J . Measurement of side effects of drugs. Br Med J. 1974; 2(5921):698-9. PMC: 1611170. DOI: 10.1136/bmj.2.5921.698. View