The International Committee of Medical Journal Editors (ICMJE) is proposing that authors must share the anonymised individual patient data (IPD) underlying clinical trial results published in its member journals.
The ICMJE also propose that authors include a plan for data sharing as part of clinical trial registration. To be considered for publication, ICMJE already requires the prospective registration of all clinical trials before enrolment of the first participant.
Dr Ben Goldacre, co-founder of the AllTrials campaign for clinical trial transparency, said:
“While all progress on all fronts is good news, I am somewhat concerned by the widespread emphasis on IPD from this and other initiatives, many of which (such as ClinicalStudyDataRequest) have significant budgets. This emphasis may come at the expense of initiatives to improve availability of overall study results, which is where the real demand is.
“At AllTrials we have recently conducted an overview of applications for IPD access. The key finding is: “very few applications”. We are hopefully working with Cochrane to survey systematic review authors to find out why they are not requesting such data, but I suspect the answers will be a combination of “too expensive and time-consuming to work with”, “it doesn’t add enough to summary results to justify the extra resource”, and “we didn’t know it was there”.
“It will be good to see IPD being shared and used more. However, tens of thousands of researchers are clamouring for access to summary results, while there have only been a couple of hundred requests for IPD. It is perhaps noteworthy that IPD can only be shared after review of applications, and to small numbers of individuals, after permission is granted by the company, because of the very real privacy concerns around sharing pseudonymised IPD online. Sharing summary results is simple: they just need to be placed online.
“Overall, therefore, while greater support for IPD sharing is definitely great news, it’s very odd that all this resource and effort is now going into IPD sharing, when IPD sharing is expensive and not in demand, with complex governance and access control issues, whereas summary results sharing presents no privacy issues, and has been highly in demand, for many decades, but with multiple ongoing barriers to access, and frustratingly slow progress.”
AllTrials calls for all past and present clinical trials to be registered and their full methods and summary results reported.