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."