Real-World Evidence Turns Experience into Knowledge

With greater knowledge and appropriate action, healthcare will improve. 

It is hard to argue with that. But dig deeper. To gain knowledge, scientists identify problems, gather evidence, study facts and test hypotheses, looking for evidence that will point them toward solutions. 

What’s changed in recent years is the amount of data available for study. It is growing exponentially, and is coming from an increasing number of sources. What is more, the tools that are used to study and gain value from data–so-called ‘Big Data’ techniques like artificial intelligence and machine learning–are improving at a rapid clip.  

While there is an abundance of data, the key to gaining knowledge that could help patients is organizing the data and making sense of it by using the right tools and asking the right questions. 

Sanofi is harnessing these new tools to go beyond traditional experimental methods and gather insights from the growing volume of real-world data to improve patient care.  This data would complement the traditional data that comes from clinical trials. 

“By analyzing real-world data, we seek to obtain a better understanding of the value of our product in real life, its effectiveness and safety,” said Javier Jimenez, Vice President, Global Head for Real-World Evidence and Clinical Outcomes at Sanofi. “In the future, we aim to provide an approach that is much more tailored to the individual patient.”

So what exactly is real-world evidence? It is clinical evidence of the use and potential benefit/risk of medical products generated from the analysis of health records, behavioral data, socio-economic and environmental conditions, sourced from hospitals, insurance claims, wearable devices, or even social media. All this information can potentially improve decision making when it comes to health. Taken together and carefully treated – and in compliance with data privacy regulations, it provides insights and touchpoints that could lead to better medicines and methods, and improved patient care. 

Real-world evidence can provide critical information about treatments while potentially reducing the costs and timeline for developing a drug. 

Traditional clinical trials, with their relatively small, carefully vetted samples, are good at evaluating the safety and effectiveness of treatments. But data collected from the real world   could provide insights from information like the patient’s ability to have access to quality health care, or socio-economic, behavioral and lifestyle factors.  

A clinical trial may not uncover the fact that patients who gain weight on a certain treatment dial back from recommended dosages, for example, but data from surveys and doctor visits could, given careful collection and analysis.  

“All of this information on top of the information obtained from clinical trials contributes to a more integrated view of the interaction of patient biology, the health system, and patient behavior. To illustrate this, a typical published article may include hundreds of variables, whereas a RWE study may include thousands of variables such as patient behavior, socio-economic data or details of other comorbidities and treatments. In this way, these studies are more patient-focused than product-focused,” said Jimenez. 

Sanofi already employs machine learning and artificial intelligence to analyze anonymized data from the records of about 450 million patient lives in its DARWIN real-world data platform. The company is now reinforcing its leadership in exploring real-world evidence and announced on November 20 it was joining forces with Aetion, a company founded by Harvard Medical School faculty members. The collaboration will integrate the Aetion Evidence Platform with DARWIN to analyze real-world data and seek to produce transparent, rapid, and scientifically validated answers on treatment effectiveness, safety, and value.

Real-world data and real-world evidence are not part of a short-term trend. This is the future, and Sanofi is poised to be a leader in optimizing the use of such evidence to improve patients’ lives while maintaining privacy and data security.

“The ultimate goal of pharma’s use of data and analytics is to improve the health of people living with disease,” said Dr. Bernard Hamelin, Global Head of Medical Evidence Generation for Sanofi. “To do that, we’re building an ecosystem of data, analytical platforms and experts.”

"What Aetion provides is a structured approach to data analysis,” Jimenez said. “The key component is that Aetion provides workflows to make the analysis of the data consistent across different teams.”

While the U.S. Food and Drug Administration (FDA) has been using real-world evidence in safety evaluations for years, it is seeking pilot programs to expand the use of such data into areas like helping define new subgroups of patients, new indications on labels, or in the design of clinical trials. 

“The point is not to replace clinical trials, but to augment them by continuing to study the effects of therapies in the real world and using that information to constantly refine and improve patient care,” Jimenez said. “The fact that the FDA has opened the door to start using real-world evidence more is really critical,” he added. This indicates that real-world evidence could, in the near future, be used to assess effectiveness, in the approval of new indications and new compounds. "It is going to be a journey.” Jimenez added.

The goal, according to Jimenez, is to build a cycle, with patient data going out for analysis but also coming back to the patient in the form of curated information. That “could give the patient power to make decisions about the day-to-day management of their health,” Jimenez said. 

“Many companies have taken to calling advanced data analysis techniques augmented intelligence, rather than artificial intelligence,” Jimenez said. He pointed out that automating a lot of processes is already “giving more time for humans to focus on what is really relevant.” 

“It all comes back to our goal of making better decisions about healthcare delivery and providing the best information to make the right decision for each patient at any point in time,” Jimenez said.

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