[Assessing adverse reactions in clinical trials].
The intake of each drug represents an intervention into the complex human                     organism. In addition to the desired therapeutic effect, adverse reactions (AR)                     can occur. Package inserts should inform patients about the safety profile of                     drugs, but how reliable is this information and how are side effects determined?                     To explore this question, we reviewed data related to the ascertainment of                     adverse reactions in clinical research from 1977 to 2011. This article sums up                     the results of our literature research as well as own experiences in clinical                     research. It reveals very different methods of assessing side effects, discusses                     the obvious problems with inconsistent data collection and presents possible                     solutions. To create valid and comparable side effect profiles of drugs and thus                     ensure the safe use of medicine, a common European standard for the structured                     assessment of Adverse Reactions (AR) in clinical research, that does not exist                     yet, is required.
Koordinierungszentrum für Klinische Studien Marburg, Philipps-Universität Marburg. susanne.harnisch@kks.uni-marburg.de
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D002986:Clinical Trials as Topic / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology* / Q000517:prevention & control*; D005858:Germany; D006801:Humans; D012107:Research Design