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BMJ Open. 2017 Dec 21;7(12):e018587. doi: 10.1136/bmjopen-2017-018587.

Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study.

Zeitoun JD1,2,3, Ross JS4,5,6,7, Atal I1,8, Vivot A1,8, Downing NS9, Baron G1,8,10, Ravaud P1,8,10,11.

Author information

1
Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.
2
Department of Gastroenterology and Nutrition, Saint-Antoine Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
3
Department of Proctology, Groupe Hospitalier Diaconesses-Croix Saint-Simon, Paris, France.
4
Department of Internal Medicine, Robert Wood Johnson Foundation Clinical Scholars Program, Yale School of Medicine, New Haven, Connecticut, USA.
5
Department of Internal Medicine, Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
6
Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut, USA.
7
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, USA.
8
INSERM UMR 1153, Centre de Recherche Épidémiologie et Statistique Paris Sorbonne Cité (CRESS), METHODS Team, Paris, France.
9
Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
10
Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
11
Department of Epidemiology, Columbia University Mailman School of Public Health, New York, USA.

Abstract

OBJECTIVES:

To characterise postmarketing studies for drugs that were newly approved by the US Food and Drug Administration and the European Medicines Agency.

DESIGN AND SETTING:

Cross-sectional analysis of postmarketing studies registered in ClinicalTrials.gov until September 2014 for all novel drugs approved by both regulators between 2005 and 2010. Regulatory documents from both agencies were used.

PRIMARY AND SECONDARY OUTCOME MEASURES:

All identified postmarketing studies were classified according to planned enrolment, funding, status and geographical location, and we determined whether studies studied the originally approved indication.

RESULTS:

Overall, 69 novel drugs approved between 2005 and 2010 were eligible for inclusion. A total of 6679 relevant postmarketing studies were identified; 5972 were interventional (89.4%). The median number of studies per drug was 55 (IQR 33-119) and median number of patients to be enrolled per study was 60 (IQR 28-183). Industry was the primary sponsor of 2713 studies (40.6%) and was a primary or secondary sponsor in 4176 studies (62.5%). In all, 2901 studies (43.4%) were completed, 487 (7.3%) terminated, 1013 (15.2%) active yet not recruiting, 1895 (28.4%) recruiting and 319 (4.8%) not yet recruiting. A total of 80% of studies were conducted in only one country and 84.4% took place in Europe and/or North America; 2441 (36.5%) studied another indication than the originally approved indication. Studies designed in the originally approved indication were found to be more industry-sponsored than others 68.7%vs53.7%; P<0.0001.

CONCLUSIONS:

Postmarketing pharmaceutical research was highly variable and predominantly located in North America and Europe. Postmarketing studies were frequently designed to study indications other than the originally approved one. Although some findings were reassuring, others question the lack of coordination of postmarketing research.

KEYWORDS:

epidemiology; therapeutics

PMID:
29273664
PMCID:
PMC5778291
DOI:
10.1136/bmjopen-2017-018587
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Competing interests: J-DZ reports that he serves as an advisor for several consulting firms and communication companies linked with the pharmaceutical industry (Cepton, Oliver Wyman, Roland Berger, McCann Healthcare, Omnicom, Grey Healthcare, Saatchi and Saatchi Healthcare, Sudler & Hennessey, TBWA, inVentiv Health France, Havas). He also reports compensation for lectures given to manufacturer professional associations; collaboration with Mayoly-Spindler, Merck, Teva, Johnson & Johnson and Menarini; unpaid consultancy for EY; conducting workshops funded by Amgen; and being invited to a French medical congress by AbbVie. JSR receives support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing; from the Centers of Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting; from Medtronic and the US FDA to develop methods for postmarket surveillance of medical devices; from the Blue Cross Blue Shield Association to better understand medical technology evaluation and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency (CRIT) at Yale.

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