Applied Clinical Trials
Parexel and TriNetX has announced a strategic effort through which they will securely connect healthcare data to support the development of richer, actionable insights intended to accelerate the execution of clinical research. Working with Parexel’s strategic partner Datavant, also a partner of TriNetX, the integrated offering will leverage Datavant’s privacy-protecting linking technology to connect Parexel’s study operations data with de-identified data from TriNetX’s network of global healthcare organizations, streamlining access to real-world data (RWD) to enhance clinical trials and deliver new therapies.
“Our industry has been moving toward more widespread use of real-world data to support clinical development, accelerated by the COVID-19 crisis and informed by new regulatory guidance,” said Michelle Hoiseth, Chief Data Officer, Parexel. “Access to richer real-world data on-demand has become even more critical. Together with TriNetX and Datavant, Parexel has taken an important step forward in its strategy to connect data in a manner that complies with privacy regulations and our data policies at the patient level, bringing the right patient to the right trial at the right time to significantly enhance and accelerate clinical development."
TriNetX’s built-for-purpose user interface and analytics capabilities can streamline workflows in study modelling and decision making. Combining capabilities in this way provides more meaningful access to site-level data, enabling Parexel and its biopharmaceutical customers to determine exactly how many patients meet criteria and, with real-time scenario modeling, see how different variables might impact patient eligibility. The data can then be shared with the clinical site, which can then quickly identify patients and begin enrollment, saving time in the execution of real-world data studies. “We are already collaborating together on several COVID-19-related research efforts with the potential to change how we use real-world data in clinical research,” noted Peyton Howell, Executive Vice President and Chief Commercial & Strategy Officer at Parexel.
“We have seen first-hand during the COVID-19 pandemic the potential of real-world data to transform the clinical trial process and bring new therapies to patients faster,” said Gadi Lachman, CEO of TriNetX. “This collaboration will enhance the use of RWE at the site level where we see the closest interaction with patients.”
The strategic initiative among Parexel, TriNetX, and Datavant also provides the benefit of secure and rapid exchange of real-world data using Datavant’s privacy-protecting linking technology. With this capability, sponsors and sites can safely and easily exchange data that has been de-identified to make rapid decisions about site and study feasibility, enabling rapid start-up and more quality execution of clinical trials, and linking clinical trial data and real-world data to support additional analysis.
“Integrating real-world data into the clinical development process has the potential to increase the amount of information gained from each trial, and thus dramatically accelerate the drug development process,” said Travis May, CEO of Datavant. “We are proud to be working with both Parexel and TriNetX to enhance such real-world data studies by allowing clinical trial data to be linked to real-world data while ensuring regulatory compliance and protecting patient privacy.”