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A digital path for studies
PARIS & CAMBRIDGE, Mass.—Researchers have come to increasingly rely on computer technology to make their work more efficient and more effective. Nowhere is that more relevant than in biopharmaceuticals, where Sanofi has used advanced digital technology as one of its key strategies. One of the major areas of focus for the company is to improve the clinical trial process, in order to reduce drug development cycle times and costs.
Sanofi announced in January a collaboration with TriNetX, a health technology and data company which operates an extensive cloud-accessible federated health research platform. TriNetX technology can be applied to clinical trials in a variety of ways that promise to reduce the complexity of trial design, increase recruitment success and help streamline the work of trial investigators.
Jennifer Haas, vice president of marketing at TriNetX, tells DDNews, “Sanofi has been one of the early adopters of the TriNetX platform, dating back to 2016. Sanofi leverages TriNetX for protocol design, patient feasibility analysis and site selection. A more strategic partnership evolved over the course of business.”
“Clinical trials are the essential link between our laboratory research and the real-world proof of effectiveness and safety that we need to provide to regulators in order to bring innovative therapies to the patients who need them,” said Lionel Bascles, global head of clinical sciences and operations for Sanofi. “Clinical trials are becoming ever more complex, and anything we can do to reduce the time and cost of a trial means therapies can be evaluated more rapidly and reach people faster. Working with companies like TriNetX is an important way to do that, by bringing both technology and knowledge to Sanofi’s work.”
Clinical trials begin with the creation of a protocol—a complete description of the study, its objectives, patient profiles based on medical characteristics, milestones and patient outcomes. That alone is a complex undertaking that companies like Sanofi want to streamline. Frequently, there is a need to amend the protocol during the trial for any of a number of reasons, and the more amendments there are (and the more complex), the more time the trial will take—and the more it will cost.
Sanofi has turned extensively to the application of digital technology and analysis, both its own and from outside partners, to address many of these problems. Notes Haas, “Sanofi, as do most pharmaceutical companies, sits on lots of data; being able to leverage that intelligence in combination with external data partners presents opportunities to accelerate clinical research.”
“The hallmark of TriNetX is a real-world evidence-based platform that presents data
through a user-friendly application with rich analytics, rendering it applicable in the designing of
protocols, assessing of feasibility and identification of a potential patient cohort,” Haas explains.
“The TriNetX data set is a unique asset and analysis tool, significantly reducing the time (to a
matter of minutes)—what traditionally has taken weeks or months to perform, can now be done
in real-time by trial investigators.”
TriNetX’s technology can analyze billions of clinical facts about its patient population to support
real-time modeling of proposed clinical trial protocols. Researchers can quickly visualize how
these protocols would be expected to operate in an actual trial and make rapid modifications to
accommodate that information. The technology also uses predictive analytics, so researchers can
forecast the expected size of the patient population that might meet the study criteria.
The technology provides access to investigators and institutions who not only can help carry out the trial, but also are most likely to help identify eligible patients for the trial who otherwise might be missed.
“TriNetX’s global health research network consists of 68 healthcare organizations, representing
95 million patients. TriNetX combines electronic medical record data with genomics
and deep oncology data, then presents that data through a user-friendly application that enables
pharmaceutical companies to analyze patient populations and perform ‘what-if’ analyses
in real time,” says Haas. “Biopharmaceutical companies and clinical research organizations
have access to the institution’s de-identified patient data and are presented with aggregate views,
but each data point in the TriNetX network can be traced to healthcare organizations who have
the ability to identify individual patients, allowing clinical researchers to develop virtual patient
cohorts that can then be re-identified for potential recruitment into a clinical trial.”
“The application of real-world evidence combined with advanced analytics takes the ambiguity out of clinical trial design, and we are very proud of the contributions that our technology has had on Sanofi’s efforts to reduce amendments and improve trial efficiency,” said Gadi Lachman, CEO of TriNetX. “Working with Sanofi and its extensive set of ongoing and planned clinical trials also brings significant value to TriNetX’s healthcare organization members, both in the U.S. and globally.”
TriNetX joins two other key relationships Sanofi has established in digital clinical trials in the past year. In March 2017, Sanofi announced a working relationship and investment in Science 37, a Los Angeles-based company that facilitates and oversees digital clinical trials, making it possible to work readily with a widely dispersed patient population and gather real-time data on the trial. In July 2017, Sanofi also announced a relationship with Evidation, which identifies and monitors digital biomarkers in patients to better understand therapeutic outcomes and the different factors that may affect those outcomes.
“Sanofi is proud to be working with leading companies around the world to implement our digital strategy in an effort to bring great drugs to the right patients, faster,” remarked Heather Bell, global head of digital and analytics at Sanofi. “We are delighted to welcome TriNetX to our group of digital partners; our new collaboration is an important step in Sanofi’s systematic effort to digitize clinical trials.”