There’s a broad consensus that widely sharing patient-level data from clinical trials is desirable, with potential advantages ranging from faster identification of side effects, easier confirmation of a therapy’s efficacy, and a reduction in duplicative efforts. But many in industry and academia are still reluctant to divulge their data, for a variety of reasons. Now, a new project from Boston’s Brigham and Women’s Hospital and Harvard University is trying to build a global, neutral platform for such data sharing, but some are skeptical it’s the right solution.
The idea for Vivli, from vivlíthiki, the Greek word for library, was articulated nearly 20 years ago in a dissertation written in the wake of the Human Genome Project. Informatics researcher Ida Sim, now a professor at the University of California, San Francisco, School of Medicine, was inspired then by GenBank, a website now operated by the National Institutes of Health that allowed researchers to easily upload and find full genomic sequences in one place. “I thought, ‘Why don’t we have that for human clinical trials?’” Sim said.
Despite her lobbying efforts, the idea didn’t take root, however. Clinical trial registries did emerge, such as ClinicalTrials.gov, but they typically offered only broad information about each trial and its findings, not the actual data from each trial subject.