An article in the British Medical Journal, “Restoring invisible and abandoned trials: a call for people to publish the findings” provides an interesting overview of some of the main issues and concerns that have led to a growing movement calling for more open data in medical trials.
Two basic problems of representation are driving growing concerns about relying on published research to reflect the truth. The first is no representation (invisibility), which occurs when a trial remains unpublished years after completion. The second is distorted representation (distortion), which occurs when publications in medical journals present a biased or misleading description of the design, conduct, or results of a trial. Both go against the fundamental scientific and ethical responsibility that all research on humans be used to advance knowledge and are symptomatic of a general culture of data secrecy. The end result is that the healthcare, biomedical research, and policy communities may, despite best intentions and best practices, end up drawing scientifically invalid conclusions based on only those parts of the evidence base they can see.
There’s also an accompanying editorial, “Restoring the integrity of the clinical trial evidence base“:
Public confidence in the credibility of medical research is at a low ebb. Many completed clinical trials have never been published, and many published results are incomplete or misleading. This crisis of hidden or misreported information from clinical trials—and the resulting distortion of the clinical evidence base—is widely recognized and commonly decried. It is one of the leading scientific problems of our time, but few solutions have been put forward.
And here’s a PLoS blog post discussing these, with implementation ideas.