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Considerations relating to sharing data from clinical trials

In an article in Trials this week, investigators from the Medical Research Council (MRC) Clinical Trials Unit at the University College London (UCL) provide an overview of their experiences of sharing data from clinical trials. The authors discuss the practicalities of their current approach to data sharing, including ensuring that data are discoverable and how to deal with old studies. They also describe their data sharing activities at the MRC Clinical Trials Unit.

The authors conclude: “While strongly supporting the imperative to share data, we believe that there are a number of issues that require further consideration before open access to clinical trial data is possible and have therefore chosen to adopt a controlled access approach, where a reasonable request has a specific and justifiable scientific merit. This helps to safeguard the rights of patients who enter our trials, protect the intellectual property rights of the researchers who designed the trial and collected the data, and provide a barrier against unnecessary duplication. It also ensures that researchers have the necessary resources and capability to manipulate and analyse the data in accordance with their stated aims as specified in a statistical analysis plan. Funders and journals should withhold mandates for completely open access until these considerations have been adequately addressed. The current need to control access should never stand in the way of reasonable requests for data sharing.”.

The full article can be found here.



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