Evidence map›Paper›PMID 20070192›Full record

ReviewAnnual review of public health2010

Post-approval drug safety surveillance.

Robert D Gibbons, Anup K Amatya, C Hendricks Brown, Kwan Hur, Sue M Marcus, Dulal K Bhaumik, J John Mann

Abstract readReview
In one paragraph

Review in Annual review of public health, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed.

  1. Article
  2. Advances in Non-statin Lipid Therapies: A Narrative Review of Evolving Strategies for Cardiovascular Risk Reduction.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026
    Review
  3. Article
  4. Article
  5. Article
  6. A Proposal to Increase Value and Equity in the Development and Distribution of New Pharmaceuticals.International journal of health services : planning, administration, evaluation · 2022
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. A Review of Pharmacovigilance.The West Indian medical journal · 2014
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Robert D GibbonsCenter for Health Statistics, University of Illinois at Chicago, Chicago, Illinois 60612, USA. rdgib@uic.edu
Anup K Amatya
C Hendricks Brown
Kwan Hur
Sue M Marcus
Dulal K Bhaumik
J John Mann

Funding

THE NEUROBIOLOGY OF SUICIDAL BEHAVIORP50MH062185 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI MANN, JOSEPH JOHN · 2000 to 2009
$21.7M
STATISTICAL METHODS FOR MENTAL HEALTH PREVENTIVE TRIALSR01MH040859 · NIMH · UNIVERSITY OF SOUTH FLORIDA · PI BROWN, C. HENDRICKS · 1986 to 2014
$7.5M
Tools for Optimizing Prescribing, Monitoring and EducationU18HS016973 · AHRQ · UNIVERSITY OF ILLINOIS AT CHICAGO · PI LAMBERT, BRUCE L. · 2007 to 2010
$4.0M
Antidepressant Treatment and Suicidality: Biostatistical/Methodological SolutionsR01MH080122 · NIMH · UNIVERSITY OF ILLINOIS AT CHICAGO · PI GIBBONS, ROBERT D · 2008 to 2011
$2.7M
AHRQ HHS 1U18HS016973AHRQ HHS HS016973-01AHRQ HHS U18 HS016973NIMH NIH HHS MH062185NIMH NIH HHS MH40859NIMH NIH HHS MH8012201NIMH NIH HHS P50 MH062185NIMH NIH HHS R01 MH040859NIMH NIH HHS R01 MH080122
6 · The paper itself

Abstract

Following the drug-approval process, concerns remain regarding the safety of new drugs that are introduced into the marketplace. In the case of rare adverse events, the number of subjects that are treated in randomized controlled trials is invariably inadequate to determine the safety of the new pharmaceutical. Identifying safety signals for new and/or existing drugs is a major priority in the protection of public health. Unfortunately, design, analysis, and available data are often quite limited for detecting in a timely fashion any potentially harmful effects of drugs. In this review, we examine a variety of approaches for determining the possibility of adverse drug reactions. Our review includes spontaneous reports, meta-analysis of randomized controlled clinical trials, ecological studies, and analysis of medical claims data. We consider both experimental design and analytic problems as well as potential solutions. Many of these methodologies are then illustrated through application to data on the possible relationship between taking antidepressants and increased risk of suicidality.

Indexed as

Drug ApprovalDrug-Related Side Effects and Adverse ReactionsPopulation SurveillanceAntidepressive AgentsFemaleHumansMaleMeta-Analysis as TopicPoisson DistributionPropensity ScoreRandomized Controlled Trials as TopicSuicide, AttemptedAntidepressive Agents

Identifiers

PMID20070192
PMCPMC2841706

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.