A firm in Vivek Ramaswamy’s family of companies has formed a partnership with one of the world’s largest contract research organizations around real-world data in clinical trials.
Durham, North Carolina-based CRO Parexel and San Francisco-based Datavant said Wednesday that they had formed a multi-year partnership to connect real-world data across the clinical trials Parexel conducts. The partnership will entail integrating Datavant’s connectivity technology into Parexel’s standard data workflow for all studies, which the CRO said would allow sponsors to connect real-world data to their clinical trial data, whether in trial protocols or after studies are finished, with the goal of optimizing evidence generation.
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Real-world data consists of data collected from sources like electronic health records, claims and billing, product and disease registries and devices, including mobile devices. RWD and real-world evidence, which comes from analysis of RWD, have grown in importance across the drug and healthcare industries and for the Food and Drug Administration, being used to support clinical trial designs, support coverage decisions and monitor post-market safety.
“Across the industry, real-world evidence is becoming an essential component to evaluating the safety and effectiveness of drug therapies and ultimately to delivering therapeutic advances,” Parexel CEO Jamie Macdonald said in a statement. “However, one of the most significant barriers to generating real-world evidence is overcoming limitations of single-data sources.”
Companies developing RWE products and services have expressed high hopes for what its incorporation into drug development could mean. In an interview at last week’s CB Insights Future of Health conference in New York, Jeremy Rassen, president of New York-based Aetion, touted RWE’s complementary role relative to traditional means of testing drugs like randomized, controlled trials, adding that it could even be used in place of randomized trials in some cases.
Testifying to the growing importance of RWE in drug development, Aetion announced on Sept. 17 the appointment of former FDA Commissioner Scott Gottlieb – who resigned as the agency’s head in March – to its board of directors.
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Parexel is one of the largest CROs in the world and is listed on ClinicalTrials.gov as participating in 65 studies that are enrolling patients, active or set to begin recruiting. However, drug and device companies’ CRO hiring decisions are usually confidential, so the actual number of studies in which Parexel is participating is likely much higher.
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