Reporting of adverse drug reactions in randomised controlled trials – a systematic survey 英文参考文献.docVIP

BMC Clinical Pharmacology BioMedCentral Research article BMC2001Clinical, Pharmacology 1 :3 Reporting of adverse drug reactions in randomised controlled trials – a systematic survey Yoon Kong Loke* and Sheena Derry Address: Department of Clinical Pharmacology, University of Oxford, Radcliffe Infirmary, Woodstock Road, Oxford OX2 6HE, England E-mail: Yoon Kong Loke* - yoon.loke@clinpharm.ox.ac.uk; Sheena Derry - sheena.derry@clinpharm.ox.ac.uk *Corresponding author Published: 12 September 2001 Received: 16 July 2001 Accepted: 12 September 2001 BMC Clinical Pharmacology 2001, 1:3 This article is available from: /1472-6904/1/3 ? 2001 Loke and Derry; licensee BioMed Central Ltd. Verbatim copying and redistribution of this article are permitted in any medium for any non- commercial purpose, provided this notice is preserved along with the articles original URL. For commercial use, contact info@ Abstract Background: Decisions on treatment are guided, not only by the potential for benefit, but also by the nature and severity of adverse drug reactions. However, some researchers have found numerous deficiencies in trial reports of adverse effects. We sought to confirm these findings by evaluating trials of drug therapy published in seven eminent medical journals in 1997. Methods: Literature review to determine whether the definition, recording and reporting of adverse drug reactions in clinical trials were in accordance with published recommendations on structured reporting. Results: Of the 185 trials reviewed, 25 (14%) made no mention of adverse drug reactions. Data in a further 60 (32%) could not be fully evaluated, either because numbers were not given for each treatment arm (31 trials), or because a generic statement was made without full details (29 trials). When adverse drug reactions such as clinical events or patient symptoms were mentioned in the reports, details on how they had been recorded we