Call For More Transparency In Clinical Trials

Pharmaceuticals are in decline as an industry due to over-regulation, lawsuits and cultural distrust. A new initiative from the European Medicines Agency, to commit to releasing all of the information from clinical trials once the marketing authorization process has ended, is being cheered by proponents of access to data but the pharmaceutical industry is less pleased.  Writing in an editorial, PLoS Medicine writes, "As 2013 begins, it is clear that critical times lie ahead for the publishing of clinical trials, which may define the relationship between pharmaceutical companies and the public for many years to come.

Pharmaceuticals are in decline as an industry due to over-regulation, lawsuits and cultural distrust. A new initiative from the European Medicines Agency, to commit to releasing all of the information from clinical trials once the marketing authorization process has ended, is being cheered by proponents of access to data but the pharmaceutical industry is less pleased. 

Writing in an editorial, PLoS Medicine writes, "As 2013 begins, it is clear that critical times lie ahead for the publishing of clinical trials, which may define the relationship between pharmaceutical companies and the public for many years to come.

"It is no longer going to be the case, if it ever was, that a trial report published in a journal will be sufficient as the record of a trial—and if journals are not careful, such reports will become unnecessary as well.

"So in addition to this being a critical time in the relationship of pharmaceutical companies to society in general, it seems that this is a good time to renegotiate the relationship between pharmaceutical companies and medical journals."

As data become more available for reanalysis, the Editors believe that report of a trial sanctioned by the pharmaceutical company and published in a journal will no longer be considered the definitive report of the trial. Instead, this report will become just one part of the large volume of information available around a trial, to be considered in conjunction with all analyses and data. 

Over the course of 2013 as EMA defines the terms of reference for the release of data the importance of journal articles' reports of a trial will change. According to the Editors, "Some journals will find this harder to adjust to than others, especially those whose business model is heavily dependent on reprints of pharmaceutical companies' versions of trial reports."

Old NID
102209
Categories

Latest reads

Article teaser image
Donald Trump does not have the power to rescind either constitutional amendments or federal laws by mere executive order, no matter how strongly he might wish otherwise. No president of the United…
Article teaser image
The Biden administration recently issued a new report showing causal links between alcohol and cancer, and it's about time. The link has been long-known, but alcohol carcinogenic properties have been…
Article teaser image
In British Iron Age society, land was inherited through the female line and husbands moved to live with the wife’s community. Strong women like Margaret Thatcher resulted.That was inferred due to DNA…