title: Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers.
abstract: OBJECTIVE
  To determine rates of publication and reporting of results within two years for all completed clinical trials registered in ClinicalTrials.gov across leading academic medical centers in the United States.
  
  
  METHODS
  Cross sectional analysis.
  
  
  METHODS
  Academic medical centers in the United States.
  
  
  METHODS
  Academic medical centers with 40 or more completed interventional trials registered on ClinicalTrials.gov.
  
  
  METHODS
  Using the Aggregate Analysis of ClinicalTrials.gov database and manual review, we identified all interventional clinical trials registered on ClinicalTrials.gov with a primary completion date between October 2007 and September 2010 and with a lead investigator affiliated with an academic medical center.
  
  
  METHODS
  The proportion of trials that disseminated results, defined as publication or reporting of results on ClinicalTrials.gov, overall and within 24 months of study completion.
  
  
  RESULTS
  We identified 4347 interventional clinical trials across 51 academic medical centers. Among the trials, 1005 (23%) enrolled more than 100 patients, 1216 (28%) were double blind, and 2169 (50%) were phase II through IV. Overall, academic medical centers disseminated results for 2892 (66%) trials, with 1560 (35.9%) achieving this within 24 months of study completion. The proportion of clinical trials with results disseminated within 24 months of study completion ranged from 16.2% (6/37) to 55.3% (57/103) across academic medical centers. The proportion of clinical trials published within 24 months of study completion ranged from 10.8% (4/37) to 40.3% (31/77) across academic medical centers, whereas results reporting on ClinicalTrials.gov ranged from 1.6% (2/122) to 40.7% (72/177).
  
  
  CONCLUSIONS
  Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers.
authors.affiliation: Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Ruijun
authors.initials: R
authors.lastname: Chen
authors.affiliation: Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT 06510, USA.
authors.forename: Nihar R
authors.initials: NR
authors.lastname: Desai
authors.affiliation: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT 06510, USA Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Ross
authors.affiliation: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT 06510, USA.
authors.forename: Weiwei
authors.initials: W
authors.lastname: Zhang
authors.affiliation: Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Katherine H
authors.initials: KH
authors.lastname: Chau
authors.affiliation: Division of General Medicine, Department of Internal Medicine, Columbia University Medical Center, New York, NY, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Wayda
authors.affiliation: Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
authors.forename: Karthik
authors.initials: K
authors.lastname: Murugiah
authors.affiliation: Department of Medicine, University of Pennsylvania Health System, Philadelphia, PA, USA.
authors.forename: Daniel Y
authors.initials: DY
authors.lastname: Lu
authors.affiliation: Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
authors.forename: Amit
authors.initials: A
authors.lastname: Mittal
authors.affiliation: Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT 06510, USA Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA harlan.krumholz@yale.edu.
authors.forename: Harlan M
authors.initials: HM
authors.lastname: Krumholz
mesh_terms: D000046:Academic Medical Centers / Q000706:statistics & numerical data*; D002986:Clinical Trials as Topic; D003430:Cross-Sectional Studies; D016208:Databases, Factual; D006801:Humans; D011643:Publishing / Q000706:statistics & numerical data*; D014481:United States