When the Institute of Medicine states there are ‘compelling justifications for sharing clinical trial data to benefit society and future patients,’ you would expect robust recommendations contained within a 249-page report on Sharing Clinical Trial Data.
The first recommendation, however, is light on commitment, and disappoints as it refers only to stakeholders in clinical trials fostering cultures in which data sharing is the norm. But, the second recommendation, which states sponsors and investigators should commit to sharing data – in a pre-specified time limit – potentially provides an actionable measure by which trialists can be audited and held to account. The third recommendation, if implemented could prove to be an influential piece of guidance, particularly if a truly independent review panel made up of members of the lay public is involved in the governance of making clinical trial data transparent.
Providing metrics, which are actionable, accessible and auditable, is the key to effective data sharing. What is omitted from this report is a recommendation that sponsor and institutes should regularly audit their compliance with data sharing, which could provide a notable measure of quality in terms of responsible sharing of clinical trial data.
Sponsors, trialists, ethic committee and journals all have a role to play in taking forward data sharing based on this IOM report. Sponsors should seek to enact some of the recommendations outlined in the report, trialists should actively promote and ensure all of the trials they participate in are registered, published in full and promote access to their data sets. Ethics committees could ensure that data sharing agreements are part of the ethical approval process and finally Journals have a significant role to play: just like they insisted on trial registration as prerequisite to publication they could now ask for the protocol, the statistical analysis plan and the data set as a mandatory part of the agreement to publish.
The IOM are right to point out that the ‘the costs of data sharing are borne by a small subset of sponsors, funders, and clinical trialists.’ There now needs to be concerted efforts to make data sharing affordable and feasible.
This report is welcomed as it clearly indicates that sharing data benefits science and patients alike and should be the norm.
Report Release:
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