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[Assessing adverse reactions in clinical trials]
S Harnisch1, C Schade-Brittinger, W Rief
1Koordinierungszentrum für Klinische Studien Marburg, Philipps-Universität Marburg. susanne.harnisch@kks.uni-marburg.de
Deutsche Medizinische Wochenschrift (1946)
|June 28, 2012
Summary
Determining drug side effects is inconsistent. A unified European standard for assessing adverse reactions (AR) in clinical research is needed for safer medication use.
Area of Science:
- Pharmacology and Clinical Research
- Drug Safety and Pharmacovigilance
Context:
- Drug intake is an intervention with potential for adverse reactions (AR).
- Package inserts aim to inform about drug safety, but reliability varies.
- Ascertainment of AR in clinical research has evolved from 1977-2011.
Purpose:
- To review methods for assessing AR in clinical research.
- To identify challenges in data collection for drug side effects.
- To propose solutions for standardized AR assessment.
Summary:
- Literature review and clinical experience reveal diverse methods for assessing drug side effects.
- Inconsistent data collection poses significant problems in understanding AR.
- A common European standard for structured AR assessment in clinical research is lacking.
Impact:
- Highlights the need for standardized AR assessment to ensure drug safety.
- Aims to improve the validity and comparability of drug side effect profiles.
- Advocates for a European standard to enhance safe medicine usage.
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