Clinical trial data sharing: here's the challenge

Abstract

Objective: Anonymised patient-level data from clinical research are increasingly recognised as a fundamental and valuable resource. It has value beyond the original research project and can help drive scientific research and innovations and improve patient care. To support responsible data sharing, we need to develop systems that work for all stakeholders. The members of the Independent Review Panel (IRP) for the data sharing platform Clinical Study Data Request (CSDR) describe here some summary metrics from the platform and challenge the research community on why the promised demand for data has not been observed.

Summary of data: From 2014 to the end of January 2019, there were a total of 473 research proposals (RPs) submitted to CSDR. Of these, 364 met initial administrative and data availability checks, and the IRP approved 291. Of the 90 research teams that had completed their analyses by January 2018, 41 reported at least one resulting publication to CSDR. Less than half of the studies ever listed on CSDR have been requested.

Conclusion: While acknowledging there are areas for improvement in speed of access and promotion of the platform, the total number of applications for access and the resulting publications have been low and challenge the sustainability of this model. What are the barriers for data contributors and secondary analysis researchers? If this model does not work for all, what needs to be changed? One thing is clear: that data access can realise new and unforeseen contributions to knowledge and improve patient health, but this will not be achieved unless we build sustainable models together that work for all.

Keywords: Clinical trials; Data re-use; Data sharing.

Figure 1

The progress of research proposals through the CSDR system. Of the 471 proposals submitted to CSDR (2014–January 2019), 123 were withdrawn by the requestor at some point through the process. The IRP rejected 55, but 34 of these went on to resubmit revised proposals following IRP suggestions for improvements. Of the 222 that gained access to the data (in progress and completed) 41 have published at least one paper, with another 28 expecting to publish soon. CSDR, Clinical Study Data Request; IRP, Independent Review Panel.