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Good practice in publication of clinical trial results

Published online by Cambridge University Press:  02 January 2018

E. Wager*
Affiliation:
Sideview, 19 Station Road, Princes Risborough HP27 9DE, UK
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Abstract

Type
Columns
Copyright
Copyright © Royal College of Psychiatrists, 2003 

As the name implies, ghostwriting is often hard to detect, so Healy & Cattell (Reference Healy and Cattell2003) have made a valuable contribution to our understanding of this important subject by their measurement and thoughtful analysis of the practice. It is also refreshing to see such a balanced account which discusses both the benefits and potential dangers of ghostwriting.

Perhaps their most alarming observation is that the papers sponsored by the manufacturer reported ‘universally positive results’, which implies the existence of considerable publication bias. Such distortions to the published literature probably exist across all therapeutic areas and have been shown to distort the outcomes of meta-analyses (Reference Tramer, Reynolds and MooreTramèr et al, 1997) and therefore to have serious implications for evidence-based medicine (Reference Melander, Ahlqvist-Rastad and MeijerMelander et al, 2003).

Readers may be interested to know that guidelines have recently been published which call on pharmaceutical companies to endeavour to publish results of all clinical trials of marketed products (Reference Wager, Field and GrossmanWager et al, 2003). The guidelines also provide recommendations to ensure that professional medical (ghost) writers are used appropriately so that their contribution can be beneficial rather than harmful. The Good Publication Practice (GPP) for pharmaceutical companies guidelines have been publicly endorsed by several drug companies and communications agencies. Further details are available at http://www.gpp-guidelines.org.

Footnotes

EDITED BY STANLEY ZAMMIT

Declaration of interest

E.W. is an author of the GPP for pharmaceutical companies guidelines. He. also makes a living as a freelance medical writer, which sometimes involves. ghostwriting.

References

Healy, D. & Cattell, D. (2003) Interface between authorship, industry and science in the domain of therapeutics. British Journal of Psychiatry, 183, 2227.CrossRefGoogle ScholarPubMed
Melander, H., Ahlqvist-Rastad, J., Meijer, G., et al (2003) Evidence b(i) ased medicine – selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ, 326, 11711173.CrossRefGoogle ScholarPubMed
Tramer, M. R., Reynolds, J. M., Moore, R. A., et al (1997) Impact of covert duplicate publication on meta-analysis: a case study. BMJ, 315, 635640.Google Scholar
Wager, E., Field, E. A. & Grossman, L. (2003) Good Publication Practice for pharmaceutical companies. Current Medical Research and Opinion, 19, 149154.CrossRefGoogle ScholarPubMed
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