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

Why there is a need for pharmacovigilance.

W K Amery1,

  • 1Pharmaco-epidemiology and Medical Evaluation, Janssen Research Foundation, Beerse, Belgium.

Pharmacoepidemiology and Drug Safety
|April 10, 2004
PubMed
Summary

Post-marketing surveillance is crucial because clinical trials often miss drug side effects. Rare, context-specific, or hard-to-detect adverse events require real-world data for full understanding.

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

Assessment of signals generated from spontaneously reported adverse events.

Pharmacoepidemiology and drug safety·2004
Same author

Coming full circle in pharmacovigilance: communicating safety information to patients through patient package inserts.

Pharmacoepidemiology and drug safety·2004
Same author

Signal generation from spontaneous adverse event reports.

Pharmacoepidemiology and drug safety·2004
Same author

Post-marketing cohort study comparing the safety and efficacy of flunarizine and propranolol in the prophylaxis of migraine.

Cephalalgia : an international journal of headache·1996
Same author

Postmarketing study of the use of flunarizine in vestibular vertigo and in migraine.

European journal of clinical pharmacology·1996
Same author

Risk of selected serious cardiac events among new users of antihistamines.

Clinical therapeutics·1995

Area of Science:

  • Pharmacovigilance
  • Clinical Trial Methodology
  • Drug Safety

Background:

  • Medicinal product approval relies on balancing benefits and risks.
  • Real-world drug usage provides essential data beyond clinical trials.
  • Phase III clinical trials have limitations in detecting all adverse events.

Purpose of the Study:

  • To investigate the reasons why phase III clinical trials fail to detect certain drug side effects.
  • To elucidate the mechanisms behind undetected adverse events in pharmaceutical research.

Main Methods:

  • Analysis of limitations in phase III clinical trial design and execution.
  • Identification of factors contributing to the underreporting or non-detection of side effects.
  • Review of existing methodologies for adverse event detection.

Main Results:

  • Clinical trials may lack statistical power to identify rare adverse events.
  • Certain side effects manifest only in specific real-world contexts not replicated in trials.
  • Inadequate detection techniques can lead to underestimation of common side effects.

Conclusions:

  • Post-marketing surveillance is vital for comprehensive drug safety assessment.
  • Addressing trial limitations requires enhanced methodologies for detecting all drug-related adverse events.
  • Understanding these detection gaps improves future drug safety monitoring.

Related Experiment Videos