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Clin Pharmacol Ther. 2018 Jan 29. doi: 10.1002/cpt.1038. [Epub ahead of print]

Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis.

Zeitoun JD1,2,3,4, Ross JS5,6,7,8, Atal I1,4, Vivot A1,4, Downing NS9, Baron G1,8,10, Ravaud P1,4,10,11.

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Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.
Gastroenterology and Nutrition, Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris, Paris, France.
Proctology, Groupe Hospitalier Diaconesses-Croix Saint-Simon, Paris, France.
INSERM UMR 1153, Centre de Recherche Épidémiologie et Statistique Paris Sorbonne Cité (CRESS), METHODS Team, Paris, France.
Department of Internal Medicine, National Clinician Scholars Program, Yale School of Medicine, New Haven, Connecticut, USA.
Department of Internal Medicine, Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut, USA.
Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, Connecticut, USA.
Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
Department of Epidemiology, Columbia University Mailman School of Public Health, New York, New York, USA.


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.


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