UBC-Envision Group’s Russell Traynor has co-authored an article in the June issue of Pharmaceutical Marketing Europe. In a feature entitled ‘Quality Control’, Russell and Sarah L. Feeney have addressed current concerns surrounding publication planning in emerging markets.
The ongoing shift of clinical trials to emerging markets, particularly China, has inevitably been accompanied by a growth in publications to the extent that China is now the second-largest producer of biomedical research publications, and this trend is set to continue.
Publication misconduct, in particular ‘selective publication’ (ensuring maximum publication of positive data, but limited publication of negative data) and ghost writing have been the subject of a number of high-profile reports in the Western media. Against this backdrop, the International Society for Medical Publication Professionals (ISMPP) updated its Good Publication Practice (GPP) guidelines in 2009, recommending that sponsors publish studies in a timely and responsible manner and reiterating that the practice of ghost writing is unacceptable. Latterly, a number of other organizations have underlined the importance of publishing clinical trial data, irrespective of whether the results are positive or negative, in addition to posting results in clinical trial databases.
While geographical widening of clinical research is to be encouraged, there is a concern that the high standards set by the ISMPP and other organizations, to which the UBC-Envision Group adheres to at all times, might not be adhered to in the emerging markets.
In the article, available at: www.pmlive.com/find_an_article/allarticles
/categories/General/2011/june_2011/features/quality_control, Russell and Sarah outline the various concerns regarding both the quality of data from emerging regions and the representativeness of published results. They go on to explain how plagiarism and concerns about authorship are a particular issue in some journals in these territories.
Russell and Sarah surmise that these concerns are unlikely to strengthen the bond of trust between pharmaceutical companies and the medical community, which has been strained in recent times by the media stories of misconduct outlined above.
To maintain the strictest ethical standards, Russell and Sarah conclude that pharmaceutical companies should have a global publication policy that applies to all company employees around the world. The policy should confirm that companies will endeavour to publish the results of all of their studies; all authors meet the highest authorship criteria; conflicts of interest are disclosed; and professional medical writing support is fully acknowledged.
The article concludes that ‘transparent, complete and comprehensive publication of clinical trial data is an essential component in the rebuilding of pharma's reputation. Ensuring this happens in every region is paramount’.
Russell Traynor is President-Elect of the ISMPP.