by Elizabeth Loder and Trish GrovesBritish Medical Journal. 2015 350:h2373Heeding calls from the Institute of Medicine, WHO, and the Nordic Trial Alliance, we are extending our policy. The movement to make data from clinical trials widely accessible has achieved enormous success, and it is now time for medical journals to play their part. From 1 July The BMJ will extend its requirements for data sharing to apply to all submitted clinical trials, not just those that test drugs or devices. The data transparency revolution is gathering pace.2 Last month, the World Health Organization [WHO] and the Nordic Trial Alliance released important declarations about clinical trial transparency.
These announcements come on the heels of the US Institute of Medicine’s [IOM] report on sharing clinical trial data, which called for a transformation of existing scientific culture to one where “data sharing is the expected norm.” The efforts of industry, too, must be acknowledged, some of which caught many people by surprise. In particular, Medtronic’s cooperation with the Yale University Open Data project and GlaxoSmithKline’s leadership on data disclosure efforts stand out.
WHO’s statement on public disclosure of clinical trial results and the accompanying rationale reiterate the organisation’s support for registration of clinical trials. WHO declares that the main results of clinical trials should be posted on a clinical trial registry or other acceptable website and submitted for journal publication within a year of study completion. The expectation is that results will be “made available publicly at most within 24 months of completion.” The statement does not call for mandatory sharing of primary data from trials but instead “encourages” sharing of research datasets “whenever appropriate.”
In a move that is particularly welcomed by Ben Goldacre, cofounder of the AllTrials campaign, WHO also recommends disclosure of previously conducted but unreported clinical trials in a searchable and free registry and says it is “desirable” that these trials should be published in a peer reviewed journal. Goldacre notes that this is important because “the overwhelming majority of prescriptions today are for treatments that came onto the market — and were therefore researched — over the preceding decades rather than the past five years”…
Hurray for the BMJ!