Scientists increasingly rely on the latest computer technology to make their work more efficient and more effective. Nowhere is that more important than in biopharmaceuticals, where the right application of technology can accelerate the development, testing and delivery of crucial new therapies for patients.
Sanofi has made the implementation of advanced digital technology one of its key strategies, from the laboratory bench all the way to the patient. One of the major areas of focus for this strategy is to improve the all-important clinical trial process in order to reduce drug development cycle times and costs.
As part of this effort, Sanofi collaborates with TriNetX, a Cambridge, Mass., health technology and data company that operates an extensive cloud-accessible federated health research platform. Using data from electronic health records, including demographics, diagnoses, procedures, medications, labs, genomics, and deep oncology data, 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.
“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, 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.”
Reducing time from protocol to results
Clinical trials begin with the creation of a protocol – in effect, 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.
The TriNetX platform satisfies the need for efficient protocol design and recruitment. 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.
“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, 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 US 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”, said Heather Bell, Global Head of Digital and Analytics, 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.”