Journal of Cystic Fibrosis
Volume 11, Issue 1 , Pages 14-17, January 2012

Delayed publication of clinical trials in cystic fibrosis☆

  • M.N. Hurley

      Affiliations

    • Division of Child Health, School of Clinical Sciences, University of Nottingham, Nottingham, NG7 2UH, UK
    • Corresponding Author InformationCorresponding author at: Division of Child Health, School of Clinical Sciences, University of Nottingham, E Floor East Block, Queens Medical Centre, Nottingham, NG7 2UH, UK. Tel.: +44 7816 753898.
    • MH and AP contributed equally and are joint first authors.
    • ,
  • A.P. Prayle

      Affiliations

    • Division of Child Health, School of Clinical Sciences, University of Nottingham, Nottingham, NG7 2UH, UK
    • MH and AP contributed equally and are joint first authors.
    • ,
  • A.R. Smyth

      Affiliations

    • Division of Child Health, School of Clinical Sciences, University of Nottingham, Nottingham, NG7 2UH, UK
    • Cochrane Cystic Fibrosis and Genetic Disorders Group, UK

Received 22 June 2011; received in revised form 28 July 2011; accepted 2 August 2011. published online 05 September 2011.

Abstract 

Background

When the publication of important trial data is delayed, or data are never published, this will prevent the proper practice of evidence based medicine through robust systematic reviews. Clinical trial registries allow researchers to interrogate the trial protocol and afford the opportunity to identify studies that have been completed and so determine the time lag between completion and publication.

Methods

We searched ClinicalTrials.gov with the keywords ‘cystic fibrosis’. Intervention trials which had completed 1st Jan 1998–31st Dec 2010 were selected. Time to publication in a peer-reviewed journal was calculated. Survival analyses using the log rank test were undertaken.

Results

We identified 142 records. Of these, 62 had full paper publications. The median time to publication was 3.25years. Phase of study (phase one studies more delayed, p=0.024) but not source of funding (p=0.34) was associated with time to publication.

Conclusions

Clinical trials in cystic fibrosis take a considerable amount of time to report their findings. More importantly, a large number of trials fail to report at all.

Keywords: Cystic fibrosis, Publication bias, Clinical trials

 

☆ Presented at: 34th European Cystic Fibrosis Society Conference, Hamburg—June 2011 [1].

PII: S1569-1993(11)00137-8

doi:10.1016/j.jcf.2011.08.004

Journal of Cystic Fibrosis
Volume 11, Issue 1 , Pages 14-17, January 2012

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