Open Sharing of Clinical Trial Data
Abstract
The previous chapter examined the practices andmethods for sharing particle physics data and identified the key challenges and lessons learnt in the process. This chapter turns to consider the practice of the digital sharing of clinical trial data. Clinical testing of new pharmaceuticals is governed by rigorous ethics and research protocols. In this chapter, I examine how these protocols are being applied to shared data resulting from clinical trials. The examination starts by identifying the drivers for the open sharing of clinical trial data. This is followed by discussion of the role of various stakeholders in driving the data release, focusing especially on pharmaceutical regulatory agencies. I then describe the stages of data release as they have emerged in recent years and compare these stages to those at CERN. The final section discusses the challenges arising in open sharing of clinical trial data. I pay particular attention to privacy concerns—to managing the risks of data misinterpretation and to the motivations for researchers to curate and to share data and collaborate with colleagues.
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