• Login
    View Item 
    •   Home
    • Articles and other publications by RIVM employees
    • Miscellaneous
    • View Item
    •   Home
    • Articles and other publications by RIVM employees
    • Miscellaneous
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    RIVM Publications RepositoryCommunitiesTitleAuthorsIssue DateSubmit Date

    My Account

    LoginRegister

    Statistics

    Display statistics

    Hoeveel klinische geneesmiddelenstudies worden uiteindelijk gepubliceerd?

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Average rating
     
       votes
    Cast your vote
    You can rate an item by clicking the amount of stars they wish to award to this item. When enough users have cast their vote on this item, the average rating will also be shown.
    Star rating
     
    Your vote was cast
    Thank you for your feedback
    Authors
    van den Bogert, C A
    Souverein, P C
    Brekelmans, C T M
    Janssen, S W J
    Koëter, G H
    Leufkens, H G M
    Bouter, L M
    Type
    Article
    
    Metadata
    Show full item record
    Title
    Hoeveel klinische geneesmiddelenstudies worden uiteindelijk gepubliceerd?
    Published in
    Ned Tijdschr Geneeskd 2017, 161(0):D1498
    Publiekssamenvatting
    The objective of this study was to investigate the occurrence and determinants of non-publication of clinical drug trials in the Netherlands. All clinical drug trials reviewed by the 28 Institutional Review Boards (IRBs) in the Netherlands in 2007 were followed-up from approval to publication. Candidate determinants were the sponsor, phase, applicant, centers, therapeutic effect expected, type of trial, approval status of the drug(s), drug type, participant category, oncology or other disease area, prospective registration, and early termination. The main outcome was publication as peer reviewed article. The percentage of trials that were published, crude and adjusted odds ratio (OR), and 95% confidence interval (CI) were used to quantify the associations between determinants and publication. In 2007, 622 clinical drug trials were reviewed by IRBs in the Netherlands. By the end of follow-up, 19 of these were rejected by the IRB, another 19 never started inclusion, and 10 were still running. Of the 574 trials remaining in the analysis, 334 (58%) were published as peer-reviewed article. The multivariable logistic regression model identified the following determinants with a robust, statistically significant association with publication: phase 2 (60% published; adjusted OR 2.6, 95% CI 1.1-5.9), phase 3 (73% published; adjusted OR 4.1, 95% CI 1.7-10.0), and trials not belonging to phase 1-4 (60% published; adjusted OR 3.2, 95% CI 1.5 to 6.5) compared to phase 1 trials (35% published); trials with a company or investigator as applicant (63% published) compared to trials with a Contract Research Organization (CRO) as applicant (50% published; adjusted OR 1.7; 95% CI 1.1-2.8); and multicenter trials also conducted in other EU countries (68% published; adjusted OR 2.2, 95% CI 1.1-4.4) or also outside the European Union (72% published; adjusted OR 2.0, 95% CI 1.0-4.0) compared to single-center trials (45% published). Trials that were not prospectively registered (48% published) had a lower likelihood of publication compared to prospectively registered trials (75% published; adjusted OR 0.5, 95% CI 0.3-0.8), as well as trials that were terminated early (33% published) compared to trials that were completed as planned (64% published; adjusted OR 0.2, 95% CI 0.1-0.3). The non-publication rate of clinical trials seems to have improved compared to previous inception cohorts, but is still far from optimal, in particular among phase 1, single-center, not prospectively registered, and early terminated trials.
    PMID
    28659210
    URI
    http://hdl.handle.net/10029/620977
    Collections
    Miscellaneous

    entitlement

    Related articles

    • Non-Publication Is Common among Phase 1, Single-Center, Not Prospectively Registered, or Early Terminated Clinical Drug Trials.
    • Authors: van den Bogert CA, Souverein PC, Brekelmans CT, Janssen SW, Koëter GH, Leufkens HG, Bouter LM
    • Issue date: 2016
    • Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study.
    • Authors: van den Bogert CA, Souverein PC, Brekelmans CT, Janssen SW, van Hunnik M, Koëter GH, Leufkens HG, Bouter LM
    • Issue date: 2015 Jul 7
    • Primary endpoint discrepancies were found in one in ten clinical drug trials. Results of an inception cohort study.
    • Authors: van den Bogert CA, Souverein PC, Brekelmans CTM, Janssen SWJ, Koëter GH, Leufkens HGM, Bouter LM
    • Issue date: 2017 Sep
    • Non-publication and publication bias in reproductive medicine: a cohort analysis.
    • Authors: Lensen S, Jordan V, Showell M, Showell E, Shen V, Venetis C, Farquhar C
    • Issue date: 2017 Aug 1
    • Time to publication of oncology trials and why some trials are never published.
    • Authors: Chapman PB, Liu NJ, Zhou Q, Iasonos A, Hanley S, Bosl GJ, Spriggs DR
    • Issue date: 2017

    DSpace software (copyright © 2002 - 2023)  DuraSpace
    Quick Guide | Contact Us
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.