Detecting Treatment Emergent Adverse Events in Clinical Trials
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ORIGINAL RESEARCH ARTICLE
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Detecting Treatment Emergent Adverse Events in Clinical Trials A Comparison of Spontaneously Reported and Solicited Collection Methods Joachim F. Wernicke, Douglas Faries, Den´ai Milton and Karen Weyrauch Lilly Research Laboratories, Indianapolis, Indiana, USA
Abstract
Background: The collection of adverse event data is an important component of clinical trials, but it is not clear whether solicited or unsolicited collection methods are better at distinguishing drug effects from the effects of placebo. The objective of this analysis is to compare the reporting rates and the ability to detect drug-placebo differences with spontaneous versus solicited adverse event collection methods. Methods: Adverse events were collected by spontaneous (unsolicited) reporting and by structured questionnaires in three randomised, double-blind clinical trials. For both spontaneous and solicited adverse event collection methods, a drug/ placebo (D/P) reporting ratio was computed by dividing the reporting rate for the experimental drug by the reporting rate for placebo for each adverse event. An index (Sp-So index) was calculated by dividing the spontaneous D/P ratio by the solicited D/P ratio. A number >1.0 indicates that the spontaneous adverse event collection method is more effective in distinguishing the drug from placebo and a number 1.0 for 22 of the 29 (75.9%) events examined, suggesting that spontaneous collection of adverse events is more effective in distinguishing drug effect from placebo than the solicited approach. However, more statistically significant differences between drug and placebo were detected by the solicited method (nine events) than the spontaneous method (five events). This is due, in part, to the fact that differences in the percentages of adverse events between drug and placebo (rather than ratios of event rates) were more often greater when the solicited approach was used. Conclusions: As expected, adverse events collected by solicitation leads to higher reporting rates. However, it is not clear that solicitation of events leads to greater ability to detect drug-placebo differences. By using a ratio to assess drug-placebo differences, spontaneous reporting provided larger drug-placebo differences more often than solicitation.
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Background One of the main goals of clinical trials is to establish the safety profile of the compound under investigation. Although collection and reporting of adverse events is a key feature in describing the safety profile of a drug, there is no general consensus as to the best way to do this. Most often, adverse events are collected in an unsolicited manner. Patients are asked if they have had any problems or if anything unusual has happened since their last visit. Any information reported by the patient in response to this question is considered a spontaneously reported adverse event. The spontaneous adverse event collection method provides the data for most pharmaceutical product labell
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