Clinical trials are run by pharmaceutical companies (and elsewhere) primarily in order to demonstrate safety and efficacy of new drugs and/or treatment regimes. Sharing such data for research use by third parties is regarded as good scientific practice as it allows meta-analysis, replication studies and so forth. It also promotes transparency; and indeed pharmaceutical companies are now required to share clinical study reports (extensive documents that include structured and unstructured data) with regulatory agencies such as the European Medicines Agency and Health Canada, who in turn publish them.
However, such sharing carries with it risk to participant confidentiality, which is both a legal requirement and vital to ensuring participation in future trials. To date these risks are not well understood.
The proposed project would develop new methods to understand the privacy risks associated with participation in clinical trials. Research questions that might be tackled in the scope of the project are:
- Is it possible to electively anonymise the textual data that appears in clinical study reports?
- Could the underlying data be reconstructed by combining various different elements within a report?
- What external data might be used by an adversary to link to clinical trials data in order to identify a person with those data?
- Can we develop quantified measures of disclosure risk associated with complex data forms such as clinical study reports?
- Does the publication of aggregate statistics from clinical trials data represent any risks to participant confidentiality?
- Can the analytical utility of the reports be maintained whilst protecting confidentiality?
These are just some examples – the successful student would be able to develop the research programme within the scope of the broad topic area.
This project represents a significant opportunity to be involved in the development of important methods and infrastructure on which the future of ethical drugs development depends.
Project reference: MN44
Deadline: 14th April