Related Experiment Video
Updated: Feb 15, 2026

The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression
Published on: November 12, 2010
Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA
Jean-David Zeitoun1,2,3,4, Joseph S Ross5,6,7,8, Ignacio Atal1,4
1Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.
Abstract:
We examined whether drug-related characteristics-conditions, development, manufacturers, revenues-were associated with postmarketing research in terms of the number of trials and total population to be enrolled. We included 63 drugs, corresponding to 3,867 postmarketing trials of approved indications. On multivariable analysis, both the number of postmarketing trials and population to be enrolled were associated with expected length of treatment (ratio of means (RoM) = 2.35 and RoM = 8.65) and number of patients in pivotal trials (RoM = 1.11 and RoM = 1.25 per thousand patients). The number of postmarketing trials was increased for drugs approved with surrogate endpoints (RoM = 2.19), generating high revenues (RoM = 1.08 per billion dollars) and addressing greater disease burden (RoM = 1.90 per hundred million disability-adjusted life years). The population to be included was increased for drugs approved after an increased number of pivotal trials (RoM = 1.82) and those unaffected by safety concerns (RoM = 2.63). Postmarketing trials seem to be driven both by medical and market factors.
Related Concept Videos
FDA Approved Drugs: Changes to Approved Drugs
Indicators
Microorganisms in Medicine and Therapeutics
Transcription Factors
Mechanical Ventilation I: Indication and Settings
Respiratory Assessment: Purpose and Indications
Objectives and Importance:
The primary goal of respiratory assessment is to evaluate patients at early risk of clinical deterioration. Since respiratory distress often precedes other signs of declining health, breathing patterns and sounds become a...

