title: Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study.
abstract: BACKGROUND
  Responsible conduct of research implies that results of clinical trials should be completely and adequately reported. This article describes the design of a cohort study that aims to investigate the occurrence and the determinants of selective reporting in an inception cohort of all clinical drug trials that were reviewed by the Dutch Institutional Review Boards (IRBs) in 2007. It also describes the characteristics of the study cohort.
  
  
  METHODS
  In 2007, Dutch IRBs reviewed 622 clinical drug trials. For each trial, we assessed the stages of progress. We discriminated five intermediate stages and five definite stages. Intermediate stages of progress are: approved by an IRB; started inclusion; completed as planned; terminated early; published as article. The definite stages of progress are: rejected by an IRB; never started inclusion; not published as article; completely reported; selectively reported. We will use univariate and multivariate Cox regression models to identify trial characteristics associated with non-publication. We will identify seven trial-specific discrepancy items, including the objectives, inclusion and exclusion criteria, end points, sample size, additional analyses, type of population analysis and sponsor acknowledgement. The percentage of trials with discrepancies between the protocol and the publication will be scored. We will investigate the association between trial characteristics and the occurrence of discrepancies.
  
  
  BACKGROUND
  No IRB-approval is required for this study. Access to confidential research protocols was provided by the Central Committee on Research Involving Human Subjects. We plan to finish data collection in June 2015, and expect to complete data cleaning, analysis and manuscript preparation within the next 3 months. Hence, a first draft of an article containing the results is expected before the end of October 2015.
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, The Netherlands Central Committee on Research involving Human Subjects (CCMO), The Hague, The Netherlands National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
authors.forename: Cornelis A
authors.initials: CA
authors.lastname: van den Bogert
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, The Netherlands.
authors.forename: Patrick C
authors.initials: PC
authors.lastname: Souverein
authors.affiliation: Central Committee on Research involving Human Subjects (CCMO), The Hague, The Netherlands.
authors.forename: Cecile T M
authors.initials: CT
authors.lastname: Brekelmans
authors.affiliation: National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
authors.forename: Susan W J
authors.initials: SW
authors.lastname: Janssen
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, The Netherlands National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
authors.forename: Manon
authors.initials: M
authors.lastname: van Hunnik
authors.affiliation: Central Committee on Research involving Human Subjects (CCMO), The Hague, The Netherlands.
authors.forename: Gerard H
authors.initials: GH
authors.lastname: Koëter
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, The Netherlands.
authors.forename: Hubertus G M
authors.initials: HG
authors.lastname: Leufkens
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Lex M
authors.initials: LM
authors.lastname: Bouter
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods*; D015331:Cohort Studies; D032984:Ethics, Research; D006801:Humans; D033181:Information Dissemination / Q000941:ethics; D004364:Pharmaceutical Preparations; D017594:Publication Bias; D011643:Publishing / Q000941:ethics; D012107:Research Design
chemical_list: D004364:Pharmaceutical Preparations
keywords: Non-publication; Publication bias; Responsible conduct of research; Selective publication; Selective reporting