Worldwide Clinical Trials and Datavant have partnered to explore the reasons clinical trials in neurodegenerative diseases fail, and how big data tactics can improve prolonged study monitoring and conduct.
The two companies plan to build a single, de-identified data set comprised of electronic health records, insurance claims and diagnostics—all linked to more nontraditional sources, including measurements from wearable devices, as well as socioeconomic and behavioral data.
And by layering on clinical trial data in a planned pilot study, the collaboration hopes to address the stubborn obstacles to conducting research studies in the field, such as slow recruitment, low patient engagement and compliance and inflexible protocol design.
Datavant recently acquired Universal Patient Key and its HIPAA-compliant de-identification technology. UPK’s platform turns protected health information into encrypted, site-specific tokens that Datavant can use to drive its data linking. The Roivant startup, its first outside drug development, was unveiled after securing $1.1 billion in investments last year.
Worldwide has been looking to expand its services in real-world data as well, acquiring Continuum Clinical’s Late Stage research practice earlier this year. The CRO said the acquisition will expand its observational research study capabilities and add pre- and postapproval services in health economics, patient-reported outcomes and patient registries.
Together, Worldwide and Datavant are focused on “the uncommon value” that big data and next-generation analytics can offer throughout the research process, said Peter Benton, president and COO of Worldwide Clinical Trials.
Neurodegenerative diseases such as Parkinson’s, Alzheimer’s, Huntington’s disorders and ALS represent staggering annual costs to the U.S. healthcare system and economy. They typically take a slow and erratic clinical course, with subtle onsets—posing specific difficulties for drug discovery, development and research, the companies said.
“The challenges that continue to persist in neurodegenerative diseases highlight the need for novel and evolved approaches to understanding both disease mechanics and patient progression,” said Datavant co-founder and CEO Travis May.