Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Using MedDRA: implications for risk management.

Elliot G Brown1

  • 1Elliot Brown (Consulting) Ltd, Barnet, United Kingdom. eb@ebconsulting.co.uk

Drug Safety
|May 25, 2004
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

The monitoring medicines project: a multinational pharmacovigilance and public health project.

Drug safety·2015
Same author

Terminological challenges in safety surveillance.

Drug safety·2011
Same author

Methods and pitfalls in searching drug safety databases utilising the Medical Dictionary for Regulatory Activities (MedDRA).

Drug safety·2003
Same author

Effects of coding dictionary on signal generation: a consideration of use of MedDRA compared with WHO-ART.

Drug safety·2002

The Medical Dictionary for Regulatory Activities (MedDRA) impacts risk management and clinical trial safety data analysis. Careful evaluation and clear regulatory guidance are needed for its effective use in pharmacovigilance.

Area of Science:

  • Pharmacovigilance and Regulatory Science
  • Clinical Trial Data Analysis
  • Risk Management

Background:

  • The Medical Dictionary for Regulatory Activities (MedDRA) is a standardized terminology impacting regulatory activities.
  • Its implementation affects clinical trial safety data analysis and risk management performance.

Purpose of the Study:

  • To evaluate the impact of MedDRA on risk management and pharmacovigilance.
  • To identify challenges and propose solutions for MedDRA implementation in various regulatory contexts.

Main Methods:

  • Review of commonly used terms in clinical trial tables from ten product labels.
  • Discussion of MedDRA's use in spontaneous reporting systems, safety databases, and periodic safety update reports.
  • Exploration of MedDRA's role in pharmacoepidemiology and risk communication.

Related Experiment Videos

Main Results:

  • Each adverse event can be represented by multiple MedDRA preferred terms, potentially hindering the identification of incidence differences between treatment arms.
  • Variability in MedDRA implementation and version management poses limitations for comparative data analysis.
  • Uncertainty exists regarding optimal MedDRA usage in signal detection, case retrieval, and risk communication.

Conclusions:

  • MedDRA's characteristics must be considered for effective signal detection and evaluation.
  • Careful evaluation of MedDRA's functions in pharmacovigilance is necessary.
  • Definitive regulatory guidance on MedDRA's use is required to ensure consistent and accurate application.