Global contract research organization (CRO) Parexel and healthcare research specialist TriNetX are collaborating on a project seeking to improve access to and use of real-world data in clinical research. Together with healthcare data analysts at Datavant, the partners aim to connect to healthcare data, in order to support development of richer insights in the hopes of accelerating the execution of research.
According to the companies, the integrated offering will leverage Datavant’s privacy-protecting linking technology, in order to connect Parexel’s study operations data with de-identified data from TriNetX’s global healthcare organization network. The intent is to effectively streamlining access to RWD, to help enhance clinical trials and bring new therapies to market faster.
Michelle Hoiseth, chief data officer for Parexel, said the global pandemic has caused interest in RWD and other advanced technologies to spread in the industry.
“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,” she said. “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,” Hoiseth added.
TriNetX’s built-for-purpose user interface and analytics capabilities reportedly make it possible to streamline workflows in study modelling and decision making. The intent behind the combination of capabilities is to deliver more meaningful access to site-level data, enabling Parexel and its customers to determine how many patients meet the criteria and (via use of real-time scenario modeling) gauge how different variables might impact patient eligibility.
At that point, data reportedly can be shared with the clinical site, which researchers can use to identify patients and begin enrollment, saving time in the execution of real-world data studies. Peyton Howell, Parexel’s executive vice president and chief commercial/strategy officer, said, “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.”
Gadi Lachman, TriNetX, added, “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. This collaboration will enhance the use of real-world evidence at the site level where we see the closest interaction with patients.”
Datavant’s privacy-protecting linking technology reportedly enables sponsors and sites to quickly, safely and easily exchange de-identified data. The information enables them to make decisions about site and feasibility, so that they can achieve more rapid startup and better execution.
“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.”