Today, ten years on from publication of the
Trials commentary, the situation could not be more different: numerous organizations now recommend or require raw data to be made available, and the literature is replete with papers covering an enormously wide variety of topics on data sharing. In terms of recommendations, clinical trial data sharing has been the subject of a report from the Institute of Medicine, [
5,
6] which recommends, among other things, that funders should require trialists to share data and provide appropriate support to do so. Funders have certainly shown interest, with a group of 17 funders led by the Wellcome Trust publishing a “statement of purpose” on data sharing, including a set of principles [
7]. Some funders have gone beyond principles: the National Health, Lung and Blood Institute [
8], for instance, has developed specific data-sharing practices and a data repository currently including over half a million patients from over 100 trials and observational studies. In a recent, dramatic development, the International Committee of Medical Journal Editors has recommended that as a “condition of … publication” of a trial report, journals will “require authors to share with others the deidentified individual-patient data no later than 6 months after publication” [
9]. If fully enacted, this recommendation would transform the landscape of clinical trial data sharing. The
BMJ has already taken the lead, with a policy that now requires data sharing “on request” for all trials [
10]. Some pharmaceutical groups are following suit, with Roche stating that they will provide individual patient data from clinical trials in response to requests with “good scientific merit” [
11]. Project Data Sphere [
12] is an industry-led initiative to provide a software platform for clinical trial data sharing, and initiatives by GSK and Medtronic to share clinical trial data have received wide praise [
10].
Alongside these initiatives and recommendations, a substantial literature has been published that investigates data sharing as a research topic. We have seen papers developing data standards for clinical trials in narrow fields (for instance, polycystic kidney disease [
13] and spinal cord injury [
14]); technical papers on deidentification [
15]; numerous surveys about the practice of or attitudes to data sharing [
16‐
21]; discussion of ethical issues [
22] (including those pertaining to highly localized issues in countries such as South Africa [
23] or Vietnam [
24]); and practical guidance on how to share data [
25,
26].
All that said, the war is far from won: attitudes have shifted dramatically, tectonically, but we are yet to see clinical trial data sharing become an unquestioned norm, where, say, a researcher can readily download a data set from a trial almost as easily as they can now download the trial publication. And there are still battles to be fought: the Pharmaceutical Research and Manufacturers of America, for instance, claims to be “firmly committed to enhancing public health” but current guidelines on communication of trial results [
27] speak of making clinical trial data accessible only to investigators.