One of the perennial criticisms of the drug industry is that developers are reluctant to publish results of failed trials on the basis that doing so could negatively affect their businesses.
Recent analysis suggests there is justification for these concerns. For example, a study published last year in the Journal of the American Medical Association (JAMA) indicated that just 46 per cent of 323 trials found on Medline were “adequately registered” on the US clinicaltrial.gov website.
So, while none of the industry groups calling for more transparent publication of trials raised the issue specifically as a motivation for the comments, it must surely have played a part.
PhRMA deputy VP Mark Grayson told Outsourcing-pharma that: “PhRMA and our sister associations are always looking to enhance our voluntary industry codes, and in this case we are taking an additional step to enhance transparency relating to clinical research.”
Grayson explained that such efforts would be “in addition to our member companies' commitment, in the PhRMA Clinical Trial Principles, to register and provide summaries online of all clinical trials in patients.
“It is our hope that this additional transparency will benefit patients and healthcare professionals," he concluded.
Authourship rules
IFPMA went into more detail in its statement, explaining that within 18 months of the approval or decision to discontinue a trial member companies must submit data to peer reviewed journals regardless of their outcome.
It also explained that the guidance is designed to make authorship of trial manuscripts more transparent, which is clearly an effort to clampdown on the practice of ghostwriting.
The organisation explained that crediting someone as a study author requires them to have made a substantial contribution to the design of the trial, data acquisition interpretation, revision and final approval.
The IFPMA added that “The roles of medical writers, statisticians and other who contribute to a manuscript but who do not meet the authorship criteria should be mentioned appropriately.
“Company involvement in both the research and publication should be disclosed, and sponsors should encourage authors to disclose all relevant interests.
“The primary publication for a particular trial should provide an accurate report of its findings, including adverse events, and there should be a discussion of the strengths and limitations of the study.”