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Related Experiment Videos

[Dealing with adverse effects in phase I trials]

D Heger-Mahn1, M Mahler, R Hermann

  • 1Institut für Humanpharmakologie, Schering AG, Berlin.

Arzneimittel-Forschung
|March 1, 1995
PubMed
Summary
This summary is machine-generated.

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This survey of German human pharmacology members reveals varied practices in managing adverse events (AEs). Recommendations for AE documentation and evaluation are needed to standardize clinical trial safety monitoring.

Area of Science:

  • Pharmacology
  • Clinical Trials
  • Drug Safety

Context:

  • The Association for Applied Human Pharmacology (AGAH) in Germany surveyed its members to understand current practices in managing adverse events (AEs).
  • The survey aimed to inform recommendations for AE documentation and evaluation within the association.
  • Clinical trials involving an estimated 11,200 volunteers annually across 24 institutes were covered.

Purpose:

  • To assess the current situation regarding the management of adverse events (AEs) in clinical trials conducted by AGAH members.
  • To identify variations in AE documentation, intensity, causality assessment, coding, and serious adverse event (SAE) handling.
  • To provide a basis for developing standardized recommendations for AE management.

Summary:

  • A 54.5% response rate was achieved, with significant discussion on the commencement and duration of AE documentation.

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  • Practices varied, with 61.5% documenting AEs from the pre-trial phase and differing approaches to symptom resolution tracking.
  • Most respondents use a 3-point scale for AE intensity, but causality assessment lacks homogeneity, though 62.5% use WHO terminology for coding.

    • Impact:

    • Highlights inconsistencies in AE management protocols within German human pharmacology research.
    • Identifies a need for standardized guidelines to improve the quality and consistency of safety data collection.
    • Informs the development of best practices for AE documentation, evaluation, and reporting in clinical trials.