Since the 21st Century Cures Act passed in 2016, which required the U.S. Food and Drug Administration to develop a framework and guidance for evaluating real-world evidence, more companies are including these insights into their therapeutics and solutions.
Most notably, real-world evidence has been used to track the effectiveness of COVID-19 vaccines.
For those in the digital health world, the promise of real-world evidence has just begun. Experts say that, by using real-time data, clinicians can acquire a full, 360-view of the patient beyond the walls of the hospital. Real-world data produces real-world evidence that informs healthcare organizations about the benefits and risks associated with various interventions.
At the ViVe conference, hosted by HLTH and the College of Healthcare Information Management Executives in Miami this week, healthcare leaders shared insights into how real-world data and evidence can be used in the emerging digital health ecosystem. Here were five main points discussed at a ViVe session on real-world evidence and data.
The real-time data revolution has just begun
Dr. Jessica Mega, co-founder and chief medical and science officer of Verily, said there will be a 1,500-fold increase in health information in the next 10 years. There is data coming from biometric sensors, wearables, remote patient monitoring devices and other pertinent devices, she noted. “The ability to link what’s happening inside and outside the four walls of the clinic or hospital is becoming more robust,” Mega said. “The question becomes, how do you harness this information and live up to the promise of precision health?” Patricia Bradley, US chief commercial officer at Huma Therapeutics, said that iPhones can track people’s body mass indexes (BMI), blood pressures, steps and heart rates.
Better understanding of diseases
Mega said that the understanding of complex diseases is one place in which a lot of advances within real-world evidence is currently occurring. She uses the example of Parkinson’s disease. “What a patient experiences with tremors daily differs from what a doctor sees in the clinic. As you accentuate real-world evidence and data into research, it gets elevated into care,” she said. Mike Eaddy, vice president of real-world evidence at AbbVie, says the company is running research on Parkinson’s disease patients who have wearables to track how they’re responding to medications. “The wearable has changed how the information that’s getting back to the doctor is tracked, as well as what’s important to the patient,” Eaddy said. “All of that data being available—plus EMR and claims data—really allows us to move care forward.”
Social determinants data
Linking digital health solutions with real-world data isn’t just limited to clinical information, panelists said. There are opportunities to use real-world, social determinants of health data to improve outcomes and tailor digital therapeutics for different populations. Eaddy said that the company has developed algorithms that leverage GPS data for the sake of increased medication adherence. The information can tell pharma companies which locations are adhering to medications and whether they might be in a pharmacy desert. “It really gives you the potential to tailor interventions so patients can maximize the value of those treatments,” Eaddy said. Mega added it has the potential to reduce barriers of care for underserved populations: “If we build in health equity and think about using digital health as an extender—not putting up more barriers—we have a chance to make a huge difference.”
Who owns the data?
The increasing use of people’s real-time health data to inform potential treatments can lead to potential ethical questions around ownership and privacy. Data stewards must be willing to notify patients how their information is being used and how it can help others, says Bradley at Huma. “We have to let them know they still own the data. We don’t own it. It’s not just given out without the benefit of something. We let them know what happens to it. That’s quite a task though,” Bradley said. “There’s a lot of work to be done in that arena. As companies, we have to build that trust by having these extra mechanisms in place around protecting the data and not selling it.” Mega recommended partnering with patient-led committees and advocacy groups to build trust with these populations before leveraging their data. “Listening to the problems that people want us to solve—not we want to solve—has allowed us to make a lot of traction,” she said.
Lack of interoperability
The lack of connectivity between EMR systems, as well as with different connected devices, has incumbered progress in this area, Bradley said. “We wind up spinning our wheels and realizing that no one talks to each other,” Bradley said. “It would be nice to not have complicated systems that make it so hard (to connect with each other).” Mega seconded this opinion and said that the lack of longitudinal data has plagued both real-time clinical and research systems. “It seems like can do better,” she said.
