title: From protocol to published report: a study of consistency in the reporting of academic drug trials.
abstract: BACKGROUND
  Unacknowledged inconsistencies in the reporting of clinical trials undermine the validity of the results of the trials. Little is known about inconsistency in the reporting of academic clinical drug trials. Therefore, we investigated the prevalence of consistency between protocols and published reports of academic clinical drug trials.
  
  
  METHODS
  A comparison was made between study protocols and their corresponding published reports. We assessed the overall consistency, which was defined as the absence of discrepancy regarding study type (categorized as either exploratory or confirmatory), primary objective, primary endpoint, and--for confirmatory trials only--hypothesis and sample size calculation. We used logistic regression, χ(2), and Fisher's exact test.
  
  
  RESULTS
  A total of 282 applications of academic clinical drug trials were submitted to the Danish Health and Medicines Authority in 1999, 2001, and 2003, 95 of which fulfilled the eligibility criteria and had at least one corresponding published report reporting data on trial subjects. Overall consistency was observed in 39% of the trials (95% CI: 29 to 49%). Randomized controlled trials (RCTs) constituted 72% (95% CI: 63 to 81%) of the sample, and 87% (95% CI: 80 to 94%) of the trials were hospital based.
  
  
  CONCLUSIONS
  Overall consistency between protocols and their corresponding published reports was low. Motivators for the inconsistencies are unknown but do not seem restricted to economic incentives.
authors.affiliation: The GCP Unit at Copenhagen University Hospital, Bispebjerg University Hospital, Copenhagen, Denmark. lbe@berendt.eu.|Medicines Development & Clinical Trials, Danish Health and Medicines Authority, Copenhagen, Denmark. lbe@berendt.eu.|Present affiliation: Novo Nordisk A/S, Copenhagen, Denmark. lbe@berendt.eu.|, Nybro Vænge 3, Kongens Lyngby, DK-2800, Denmark. lbe@berendt.eu.
authors.forename: Louise
authors.initials: L
authors.lastname: Berendt
authors.affiliation: Medicines Development & Clinical Trials, Danish Health and Medicines Authority, Copenhagen, Denmark. tca@dkma.dk.|Present affiliation: Division of Pharmacovigilance and Medical Devices, Danish Health and Medicines Authority, Copenhagen, Denmark. tca@dkma.dk.
authors.forename: Torbjörn
authors.initials: T
authors.lastname: Callréus
authors.affiliation: Medicines Development & Clinical Trials, Danish Health and Medicines Authority, Copenhagen, Denmark. lgp@dkma.dk.
authors.forename: Lene Grejs
authors.initials: LG
authors.lastname: Petersen
authors.affiliation: The GCP Unit at Copenhagen University Hospital, Bispebjerg University Hospital, Copenhagen, Denmark. karin@friisbach.dk.|Present affiliation: Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark. karin@friisbach.dk.
authors.forename: Karin Friis
authors.initials: KF
authors.lastname: Bach
authors.affiliation: Department of Clinical Pharmacology, Bispebjerg University Hospital, Copenhagen, Denmark. hepo@rh.dk.|Laboratory of Clinical Pharmacology, Rigshospitalet, Denmark. hepo@rh.dk.|Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. hepo@rh.dk.
authors.forename: Henrik Enghusen
authors.initials: HE
authors.lastname: Poulsen
authors.affiliation: Department of Clinical Pharmacology, Bispebjerg University Hospital, Copenhagen, Denmark. kim.peder.dalhoff@regionh.dk.|Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. kim.peder.dalhoff@regionh.dk.
authors.forename: Kim
authors.initials: K
authors.lastname: Dalhoff
mesh_terms: D000047:Academies and Institutes; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D016015:Logistic Models; D012107:Research Design; D018401:Sample Size