Recommendations for a uniform assessment of publication bias related to funding source

BMC Medical Research Methodology

Henk J Out¹  John Overbeke³  Marlies van Lent² 

[1] Teva Pharmaceuticals, Computerweg 10, 3542 DR, Utrecht, The Netherlands;Clinical Research Centre Nijmegen, Department of Pharmacology – Toxicology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB, Nijmegen, The Netherlands;Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB, Nijmegen, The Netherlands

关键词: Uniform assessment;    Recommendations;    Trial outcomes;    Pharmaceutical industry;    Sponsorship;    Clinical drug research;    Publication bias;   

Others  :  1091589
DOI  :  10.1186/1471-2288-13-120

 received in 2013-04-25, accepted in 2013-09-27,  发布年份 2013

【 摘 要 】

Background

Numerous studies on publication bias in clinical drug research have been undertaken, particularly on the association between sponsorship and favourable outcomes. However, no standardized methodology for the classification of outcomes and sponsorship has been described. Dissimilarities and ambiguities in this assessment impede the ability to compare and summarize results of studies on publication bias. To guide authors undertaking such studies, this paper provides recommendations for a uniform assessment of publication bias related to funding source.

Methods and results

As part of ongoing research into publication bias, 472 manuscripts on randomised controlled trials (RCTs) with drugs, submitted to eight medical journals from January 2010 through April 2012, were reviewed. Information on trial results and sponsorship was extracted from manuscripts. During the start of this evaluation, several problems related to the classification of outcomes, inclusion of post-hoc analyses and follow-up studies of RCTs in the study sample, and assessment of the role of the funding source were encountered. A comprehensive list of recommendations addressing these problems was composed. To assess internal validity, reliability and usability of these recommendations were tested through evaluation of manuscripts submitted to journals included in our study.

Conclusions

The proposed recommendations represent a first step towards a uniform method of classifying trial outcomes and sponsorship. This is essential to draw valid conclusions on the role of the funding source in publication bias and will ensure consistency across future studies.

【 授权许可】

   
2013 van Lent et al.; licensee BioMed Central Ltd.

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