Article Text
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.
- therapeutics
- epidemiology
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Footnotes
Contributors J-DZ and PR were responsible for the conception and design of this work. J-DZ drafted the manuscript and was responsible for most of the data acquisition. IA was responsible for data exportation and structuration. AV was responsible for collection of some data and contributed to categorisation of studies. NSD was responsible for some of the data acquisition. GB conducted the statistical analysis. JSR and PR provided supervision. All authors participated in the analysis and interpretation of the data and critically revised the manuscript for important intellectual content.
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.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Data files are available from the corresponding author on reasonable request.