The US Institute of Medicine (IoM) has pitched into the ongoing debate about clinical data transparency with a report saying the current system “fails to provide an adequate return on the investments of trial participants, investigators, and sponsors”.
The IoM is concerned that so much clinical data is collected – through the altruistic volunteering of patients – but often lies dormant, never being published or made available to other researchers, which it says is holding back new ideas for research.
Its report suggests widespread sharing of data should be an integral part of carrying out a clinical trial, and calls for dissemination plans to be included as part of the registration of a study and overseen by an independent panel of experts.
Moreover, it concludes that the risks often highlighted from data sharing – such as privacy violations and the risk that researchers may make inappropriate use of the data – are outweighed by the benefits of transparency.
Summary results should be published within a year of a trial’s end, with the full data sets shared within 18 months of its conclusion, regardless of whether it is to be published, although the IoM acknowledges there nay have to be exceptions for certain study types.
One of the members of the IoM panel that prepared the report – New England Journal of Medicine (NEJM) editor-in-chief Jeffrey Drazen – said in an editorial that clinical data should be viewed “as a community resource, much like a shared park, rather than as personal property”.
Commenting on the IoM report, Tracey Brown, the managing director of UK charity Sense About Science and a co-founder of the AllTrials clinical transparency campaign, said it “confirms what some companies, research institutions, funders and regulators are already doing.”
“The only people who are still saying that challenges to data sharing make it impossible are the ones who are not sharing results,” she asserted.
AllTrials welcomed the report but said it would have been stronger with “clear pathways to implementation and calls for audits of compliance”.
Given that the opinion of the IoM carries considerable weight in the US healthcare sector, the bold findings in the report suggest the debate about access to clinical trial data could soon take off in America in much the same way it has in Europe.
At the moment in the US clinical results sharing is governed by a voluntary code, although the Department of Health and Human Services (DHHS) has proposed measures to tie results-reporting in with the current registration requirements for studies.
J&J expands transparency drive
As the report was published it was also announced that Johnson & Johnson (J&J) is expanding its plans to share data via the Yale Open Data Access (YODA) project, pledging to disclose data on its medical devices and diagnostics as well as its drug therapies.
The announcement comes a year after J&J became the first company to provide full and free access to data from clinical trials of its drugs to the independent third party, a first for the industry that was welcomed by AllTrials as “great step forward for access”.
Some other pharma companies have also promised to make clinical study reports (CSRs) and anonymised patient-level data available, including GlaxoSmithKline (GSK) which remains the only big pharma company to have signed up to the AllTrials campaign, but transparency advocates would prefer to see all clinical researchers – whether from industry or the public sector – held to a single, universal set of agreed standards.