Clinical studies aren’t what they used to be. In the past, the process was one-off: You conducted a study, gathered a lot of data, analyzed it, wrote a report, and submitted it to the authorities. But, says long-time Linked Data advocate Kerstin Forsberg, an information architect at AstraZeneca, that’s all changed in the last few years.

“A study is not a study on its own,” says Forsberg. Today, the goal is  to do meta-analysis across many studies, so parties ranging from  pharmaceuticals companies to contract research organizations to government authorities all are ‘customers’ of clinical data, so to speak. Data from various studies must be shared among all these parties. “It puts a new context around clinical trial data, that it must be easy to link data together, to link across several different studies,” she says.

The case is there to use modern information standards, like semantic web standards and Linked Data principles, to address this need. It’s why Forsberg is one of the individuals spearheading a volunteer effort to create RDF and OWL representations of the standards published by the Clinical Data Interchange Standards Consortium (CDISC) an international, non-profit organization that develops and supports global data standards for medical research.

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Kerstin Forsberg has written an article discussing a presentation she and Frederik Malfait gave regarding the use of semantic models for CDISC-based standard and metadata management, pointing to case studies at AstraZeneca and Roche. She writes, “In AstraZeneca we have a new program called Integrative Informatics (i2) establishing the components required to let a linked data cloud grow across R&D. A key component is the URI policy for how to make for example a Clinical Study linkable by giving it a URI, that is a Uniform Resource Identifier, e.g. http://research.data.astrazeneca.com/id/clinicalstudy/D5890C00003. Read more