There is a committee within the Institute of Medicine charged with examining the issues associated with data sharing after randomized controlled trials.
Data-sharing, without question, reflects a dire need. From companies behaving badly – such as Merck with Vioxx, or Roche with Tamiflu – to inadvertent errors in analysis, protecting the health of patients requires more than simple peer review of documents prepared for pharmaceutical corporations by medical communication professionals.
Jeff Drazen, in this editoral, makes a call for feedback to the IOM. Oddly, his main concern is – how long ought the original authors of a study be allowed exclusive access to trial data? Would open data disincentivize researchers to perform clinical investigations, knowing their academic and commercial benefit would likely be curtailed? On the flip side, we have seen publication of trial data be massively delayed – see ATLANTIS Part A, withheld for seven years – by pharmaceutical companies concerned with protecting their business interests.
It is a complicated and subtle issue, to be sure, but appropriate transparency is almost certainly an improvement over the current situation. Full details, and how to leave feedback, are at:
http://www.iom.edu/activities/research/sharingclinicaltrialdata.aspx
“Open Data”
http://www.nejm.org/doi/full/10.1056/NEJMe1400850 (open access)