Evaluating Quality of Adverse Event Information from Clinical Trials

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The numbers of adverse event reports submitted by clinical trial sponsors have been increasing. Since the reporting items were unified and adverse event reporting by electronic media was started, reviews by Institutional Review Board (IRB) have speeded up and it has become easier to understand the situation of adverse event reporting. In the present study we expressed the quality of adverse event reports in terms of objective numerical values. We report on this in the following and discuss a method of systematically evaluating all adverse event information. The Visual Analogue Scale (VAS) was used to evaluate the results of a survey of doctors (Drs) and clinical research coordinators and clinical pharmacists (CRCs). Both the Drs and CRCs regarded unexpected serious adverse event information as the most important. However, though Drs also placed importance on the possibility of a causal relationship with the drug and information concerning the outcome, CRCs were not really interested in anything other than unexpected serious adverse event information. We also determined a numerical distribution for the adverse events using a numerical conversion table for adverse events that we had created ourselves and compared their normal distributions determined on the basis of keywords relating to "Predictability" or "Seriousness". Our numerical distributions enabled the quality of the adverse event information to be systematically evaluated and the ranking of adverse events through its use should speed up reviews by the IRB.
日本医療薬学会の論文
2005-02-10

Evaluating Quality of Adverse Event Information from Clinical Trials

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