Researchers call for cull of clinical trial ghost writing
pharmaceutical company-sponsored clinical trials and calls for the
controversial practice to be culled in order to improve
transparency.
Scientific findings are usually published in the form of a "paper", normally prepared by those who undertook the research. These authors are then listed at the top of the paper and in this way, take responsibility for the integrity and interpretation of the results.
However, a growing number of academics, journal editors, and some pharmaceutical companies are concerned that that "ghost authorship" is now commonplace, and that the author list on the published paper does not tell the true story of who was involved.
The true extent of this ghost authorship in industry-initiated randomised trials has not really been known, prompting a group of academics from Denmark, Canada and England to shed some more light on the subject.
"Freelance medical writers, medical writing agencies and contract research organisations (CROs) are often contracted to compose trial reports, reviews, and other papers for the pharmaceutical industry but their role is often not revealed," said the researchers.
"This might happen because the study "looks" more credible if the true authors are not revealed."The researchers also claim that "companies and medical writing agencies may routinely disguise the fact that papers have been ghost-written, including erasing the file history of electronic documents before manuscript submission."
In addition, "writing agencies have a vested interest in pleasing their clients by writing favourably about the drug in question. Such commercial pressures may explain why conclusions in randomised trials recommended the experimental drug as the drug of choice much more often if the trial was funded by for-profit organisations, even after adjustment for the effect size," they said.
As part of their investigations, they identified every pharmaceutical industry-sponsored trial that was approved by the ethics committees of Copenhagen and Frederiksberg in Denmark between 1994 and 1995, and then subsequently finished and published - a total of 44 trials.
For the purposes of the study, ghost authorship was defined - using the policies set out by a group called the International Committee of Medical Journal Editors (ICMJE) - as "present if individuals who wrote the trial protocol, performed the statistical analyses, or wrote the manuscript, were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment."
The small sample size and the dates for the protocols were acknowledged as possible study limitations.
The study found evidence of ghost authorship for 33 trials (75 per cent) and this was increased to 40 trials (91 per cent) when the researchers included cases where a person qualifying for authorship was acknowledged rather than appearing as an author.
"We did not find any trial protocol or publication that stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis," said the researchers.
"We found no references to medical writers in the protocols we reviewed, and they were acknowledged in only four publications (nine per cent), which is consistent with a recent review of research articles."
Although these findings "are in sharp contrast to a survey of 504 authors of manuscripts submitted to the BMJ and the Annals of Internal Medicine," the researchers stated that "to our knowledge, this study is the first that has systematically examined the prevalence of ghost authorship using a cohort of protocols and corresponding publications."
As a result, they concluded that "ghost authorship in industry-initiated randomised trials is very common, and we believe that this practice serves commercial purposes - probably because of the perceived marketing advantage of papers that appear to have been written entirely by clinicians."
They also said that the findings suggest that the ICMJE's guidelines on good publication practices for pharmaceutical companies - published in 2003 - "are very often ignored."
"This means that people who read a published paper cannot always accurately judge or trust the information presented within it, and competing interests may be hidden," claim the researchers.They take particular issue with the "widespread practice of not including statisticians as authors for reports of randomised trials."
"The statistical report is a fundamental part of the research that has a crucial influence on what is written in the publication. Omission of a company statistician usually deprives readers of a key insight into the role of the company," they said.
Given the study conclusions, the researchers have called for the practice of ghost authorship to be culled in order to improve transparency and accountability.
Specifically, they suggest that as existing guidelines state, protocols should be made publicly available "so that everyone can see what trials are planned and who is involved in conducting them," and that journals should not only list the authors of each paper but describe what each author has done, "so that the published information accurately reflects what has been carried out."
"The prevalence of ghost authorship could be considerably reduced if the existing guidelines on good publication practices for pharmaceutical companies were followed," said the researchers.
"For the most part, the current situation does not reflect these recommendations. Only six pharmaceutical companies have so far endorsed the guidelines and although 18 CROs and communications companies have agreed to recommend the guidelines to their clients and to follow them in their work, such contractors might not be aware of omissions of qualifying authors and may not be able to convince their clients to comply."
The UK offices of CRO giants Covance, Quintiles and Parexel were all contacted for comment, as well as The International Committee of Medical Journal Editors, the World Association of Medical Editors and the European Medical Writers Association but they were all unavailable for comment at the time of publication.
The study, titled: "Ghost Authorship in Industry-Initiated Randomised Trials," can be viewed >here.
