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

Post-marketing surveillance: a UK/European perspective.

Stephen Gough1

  • 1Division of Medical Sciences, University of Birmingham, Birmingham, UK. s.c.gough@bham.ac.uk

Current Medical Research and Opinion
|May 19, 2005
PubMed
Summary

Regulatory approval enables controlled drug prescription. Post-marketing surveillance (PMS) studies are crucial for detecting adverse drug reactions in the general population, despite clinician skepticism towards non-randomized trials.

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

Pharmacogenomics of GLP-1 receptor agonists: a genome-wide analysis of observational data and large randomised controlled trials.

The lancet. Diabetes & endocrinology·2022
Same author

Reducing hyperglucagonaemia in type 2 diabetes using low-dose glibenclamide: Results of the LEGEND-A pilot study.

Diabetes, obesity & metabolism·2022
Same author

Comment on: "Achieving Glycaemic Control with Concentrated Insulin in Patients with Type 2 Diabetes".

Drugs·2019
Same author

Does Islet Size Really Influence Graft Function After Clinical Islet Transplantation?

Transplantation·2018
Same author

Reduced risk of hypoglycemia with insulin degludec versus insulin glargine in patients with type 2 diabetes requiring high doses of basal insulin: a meta-analysis of 5 randomized begin trials.

Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·2013
Same author

Recent advances in incretin-based therapies.

Clinical endocrinology·2012

Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Regulatory Science

Background:

  • Pre-licensing drug trials often involve limited patient numbers (<5000) and exclude specific populations (women, elderly, children) or those with co-existing conditions.
  • Adverse drug reactions (ADRs) are frequently identified only after a drug is released to the general population.
  • Current post-marketing pharmacovigilance systems rely on voluntary clinician participation, leading to widespread under-reporting.

Purpose of the Study:

  • To discuss post-marketing pharmacovigilance and the role of Post-Marketing Surveillance (PMS) studies.
  • To highlight the importance of PMS studies in drug safety evaluation.
  • To examine PMS within the framework of UK and European legislation.

Main Methods:

  • Review of regulatory systems for pharmacovigilance.
  • Discussion of the limitations of pre-licensing trials.
  • Analysis of the value and challenges of Post-Marketing Surveillance (PMS) studies.

Main Results:

  • Many adverse drug reactions are detected post-approval due to limitations in pre-licensing trial populations.
  • Clinician skepticism towards non-randomized controlled trial (RCT) designs can lead to underutilization of PMS data.
  • PMS studies offer valuable insights from large patient populations often excluded from initial trials.

Conclusions:

  • Post-marketing pharmacovigilance is essential for comprehensive drug safety monitoring.
  • PMS studies, despite methodological differences from RCTs, provide critical real-world data.
  • Integrating PMS studies more effectively into drug launch strategies is recommended within current regulatory frameworks.

Related Experiment Videos