Study, Sept/16: "The Value of Transparency When Reporting Adverse Events"

This information will surprise no one here on BB, but it's extremely important that it has been studied and brought to light. Whether it will change anything remains to be seen.

"A new study published in the journal PLoS Medicine has found strong evidence that a significant portion of information on adverse events, gathered from clinical trials, remains unpublished."

------

The value of a treatment is a combination of its efficacy and its unwanted effects. A drug that improves disease symptoms while simultaneously causing adverse events that lead to additional treatment or hospitalization may not be the most valuable option. Unless all the documented evidence that results from a study is openly published by participating researchers and drug developers, patients and physicians will remain ill-informed when making care decisions. Publication bias and unreported harms data could lead to erroneous judgement by physicians on the benefit to harm ratio of a treatment. This, the authors state, calls for an urgent policy intervention to allow full public access to AE data.

http://www.ajmc.com/newsroom/the-value-of-transparency-in-reporting-adverse-events

http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002127#sec027