title: Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports.
abstract: OBJECTIVE
  To investigate characteristics of clinical trials and results on safety and effectiveness reported in US Food and Drug Administration (FDA) documents for recently approved high risk cardiovascular devices compared with the characteristics and results reported in peer reviewed publications.
  
  
  METHODS
  A search of the publicly available FDA database was performed for all cardiovascular devices that received premarket approval from 1 January 2000 to 31 December 2010. For each study listed in the premarket approval documents, a Medline search was conducted to obtain the corresponding publication.
  
  
  METHODS
  Clinical trial characteristics, primary endpoints, and safety and efficacy results in the FDA documents and corresponding publications.
  
  
  RESULTS
  106 cardiovascular devices received premarket approval from 1 January 2000 to 31 December 2010. FDA premarket approval documents for these devices contained 177 studies, of which 86 (49%) had been published by 1 January 2013. These 86 publications corresponded to 60 distinct devices. The mean time from FDA approval to publication in a peer reviewed journal was 6.5 months (range -4.8-7.5 years). In 22 (26%) of the 86 compared studies the number of participants enrolled in the study differed in the FDA summary and the corresponding publications. Of 152 primary endpoints identified in the FDA documents, in the corresponding publications three (2%) were labeled as secondary, 43 (28%) were unlabeled, and 15 (10%) were not found. Among the primary results, 69 (45%) were identical, 35 (23%) were similar, 17 (11%) were substantially different, and 31 (20%) could not be compared.
  
  
  CONCLUSIONS
  Many clinical trials for high risk cardiovascular devices approved by the FDA remain unpublished. Even when trials are published, the study population, primary endpoints, and results can differ substantially from data submitted to the FDA.
authors.affiliation: Department of Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA.
authors.forename: Lee
authors.initials: L
authors.lastname: Chang
authors.affiliation: Division of Cardiovascular Medicine, University of California, Davis, Sacramento, CA 95817, USA.
authors.forename: Sanket S
authors.initials: SS
authors.lastname: Dhruva
authors.affiliation: University of California, San Francisco School of Medicine, San Francisco, CA 94143, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Chu
authors.affiliation: Charles Perkins Centre, University of Sydney, Sydney, Australia.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Bero
authors.affiliation: Division of Cardiology, Suite M-1180, 505 Parnassus Avenue, University of California-San Francisco, San Francisco, CA 94143, USA redberg@medicine.ucsf.edu.
authors.forename: Rita F
authors.initials: RF
authors.lastname: Redberg
mesh_terms: D002986:Clinical Trials as Topic; D003430:Cross-Sectional Studies; D018795:Device Approval; D006353:Heart-Assist Devices; D006801:Humans; D010380:Peer Review; D017594:Publication Bias; D011643:Publishing; D014481:United States; D014486:United States Food and Drug Administration