Parexel embraces real world evidence, enlisting Datavant to drill it into CRO workflow
With the emergence of real-world evidence as a promising way to capture data points outside of clinical trials and speed up drug development, contract research organizations — the stalwarts of traditional trial execution — are often leading the charge in adopting new technology. Parexel, a leading player in the field, is stepping up that commitment through a deal with Datavant.
Spawned by Vivek Ramaswamy’s startup factory Roivant and led by Travis May, Datavant has positioned itself as a key aggregator linking up the disparate datasets that exist in healthcare, often in silos. In the new partnership, its software will be integrated into Parexel’s workflow such that all the data from their studies will be connected to real-world data such as electronic health records, claims and diagnostics, as well as information relating to genomics, wearable devices, socioeconomic and behavioral data and others.
All the data generated in the process are also quickly de-identified — one of Datavant’s key pitches amid increasing concerns about patient privacy.
“(O)ne of the most significant barriers to generating real-world evidence is overcoming limitations of single data sources,” Parexel CEO Jamie Macdonald said in a statement. “Partnering with Datavant has provided Parexel the ability to link disparate data sets to drive the complex analyses necessary for providing innovative scientific and clinical data strategies.”
Macdonald began working with Datavant last September, a few months after he took the helm. After hammering out how best to incorporate Datavant’s tech into Parexel’s way of designing and conducting trials, the duo has agreed to formally expand the relationship into a multi-year strategic pact.
The use of real-world evidence has gained steam as biopharma companies look to trim the cost of clinical development and advocate for a sort of patient-centric narrative in which their day-to-day experience with therapies can be taken into regulatory account. The FDA kick-started its own pilot projects to evaluate whether RWE can help predict the results of clinical trials that have yet to wrap up. The discussion is still limited to drugs already on the market — for which developers might be seeking label changes — and questions about data quality standards remain, but the momentum is there to create new ways to build a franchise treatment.
Social image: Jamie Macdonald, Travis May