The International Committee of Medical Journal Editors calls for greater sharing of clinical trial data in an editorial appearing simultaneously in the Annals of Internal Medicine and a number of other medical journals last week.
The editors write that there is "an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk."
The ICMJE proposes requiring authors to share de-identified individual patient data on which the reported results were based — both the data and metadata needed to reproduce the findings — within six months of publication. It notes, though, that as such sharing needs planning and ethics board approval, it would begin to require sharing for trials that enroll participants a year after it adopts such a guideline.
The group also calls for researchers to register their clinical trials beforehand.
"Sharing data will increase confidence and trust in the conclusions drawn from clinical trials," the editors led by Darren Taichman, the ICMJE secretary and executive deputy editor of the Annals of Internal Medicine, add.
In an essay appearing at NPR's Shots blog, Yale School of Medicine's Harlan Krumholz writes that "[a]mong the first things we learn in school are to share and to show our work. This lesson has been lost on medicine for many years. The medical editors are reminding us that we scientists have a principal responsibility to society and to those who agreed to participate in our studies."