Through the partnership, Parexel will integrate Datavant’s connectivity technology into the workflow of all of its clinical studies. This will allow trial sponsors to “optimize the evidence generation” by connecting the real-world data to clinical data either during the trial itself, or retroactively.
The use of real-world evidence, or real-world data, is becoming an essential component in the evaluation of drug therapies. At the end of 2018, the U.S. Food and Drug Administration released a strategic framework for the use of real-world evidence that indicated how the regulatory agency plans to use real-world data to improve regulatory decisions. Real-world evidence centers on the collection of information about a drug’s safety and efficacy outside of the structure of a clinical trial. Real-world data includes health data routinely collected outside of a controlled setting from insurance claims, electronic medical records, patient-reported outcomes, and patient registries and other sources.
Jamie Macdonald, chief executive officer of Parexel, pointed to the growing reliance on real-world evidence in evaluating the safety and efficacy of drug candidates. Macdonald noted that one of the most “significant barriers” to harnessing this evidence is overcoming the limitations of single data sources.
“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. We’re delighted to expand and extend our strategic partnership by using Datavant’s technology across our entire portfolio, making the ability to link data available to more customers on a broader scale,” Macdonald said in a statement.
The technology developed by Datavant allows the linking of “de-identified data” across the entire journey of a patient. That includes the use of electronic health records, claims and diagnostics. Also, that could include such things as genomics, wearable devices, socioeconomic and behavioral data and more. By connecting these different data points, it provides a “more holistic view of patient health than clinical trial data alone,” Parexel said this morning. In its announcement, Parexel said linking the real-world data sources with its clinical trials, will provide stronger data points when it comes time to present the information to regulatory agencies.
“Parexel will be uniquely positioned to pursue data collaborations with the hundreds of organizations that utilize the Datavant software, including academic medical centers, life sciences and medical device companies, insurers, and leading data aggregators and analytics companies,” the company said of its partnership with Datavant.
Travis May, co-founder and CEO of Datavant, said Parexel’s “deep clinical expertise” puts the company in a strong position to blend real-world evidence with its clinical data. The joint solution provides Parexel “the flexibility to leverage the real-world data they need, whenever they need it – all while ensuring that patient privacy is protected.”