apid advances and increasing availability of digital technologies are slowly beginning to disrupt drug development and healthcare delivery. From streamlining clinical research processes such as patient recruitment, informed consent, and monitoring, to enabling to real time data collection to help guide clinical care decision-making, practical, connected applications of digital health technology will potentially increase speed of access and generate more patient-relevant data useful to stakeholders across the ecosystem.

Key Takeaways

• Digital technology presents numerous opportunities to increase efficiency in biopharmaceutical development and healthcare delivery, in addition to offering new ways to engage with patients throughout the continuum of care.
• An increasing flow of new forms of data—both structured and unstructured—will offer new insights, enable new endpoints, and place a greater emphasis on real world evidence. A large pool of data, however, will only become actionable knowledge when the right analytics are applied to it.
• Real world evidence is poised to create a more dynamic regulatory framework, one which shifts the balance from sole dependence on randomized controlled trials to one that includes more real world data and patient preference information.
• Access to disparate data streams, better analytics, and multi-stakeholder agreement are necessary enablers to fully realize the potential benefits of digital health technology.

Why this is important: “Digital disruption is a huge ambition that encompasses the whole healthcare ecosystem—from drug development all the way through patient access,” said Chris Walker, Head of Regulatory Affairs for Europe at Amgen. “If we get this right and begin to use digital technology appropriately, we can focus on the most challenging healthcare problems and the technology will eventually help to solve those problems.”

A Connected Healthcare Data Ecosystem

In the realm of utilizing real world data to support clinical care, researchers at the University of Manchester conducted a prospective cohort study of 350 rheumatoid arthritis patients to record health-related quality of life (HRQoL) data with a patient-designed mobile application developed by uMotif. Designed specifically to identify sleep/wake rhythm-associated parameters that predict HRQoL, the QUASAR study not only validated the concept of conducting real world research virtually, it also demonstrated a marked decrease in study time and cost compared to traditional methods. Furthermore, as the largest study ever conducted to explore the relationship between rheumatoid arthritis and sleep, its findings will contribute to more informed treatment decisions.

Engaging with patients in the initial stages of digital health technology development is a common learning from many initiatives. My Studies, an open-source mobile app designed by the FDA and Kaiser Permanente to collect real world data directly from patients, included patient input on the app’s functionality and its patient questionnaire. The app is meant to be used by patients directly and can be linked to electronic health data, clinical trials, pragmatic trials, observational studies, and registries. The agency’s hope is that collecting more real world data directly from patients will lead to more efficient product development and assist with safety monitoring. My Studies was released in December 2018 in an open-source format so sponsors and developers can adapt the app to fit specific clinical trial and real world research needs.

Better Insights, Better Healthcare

The vision of a connected, continuously learning healthcare system driven by patient outcomes that is able to predict and prevent is within reach. “If we do this well, we’ll increase the speed of access to medicines because we’ll take out steps that we do right now, or we’ll do them faster and get them done cheaper,” said Walker. “Hopefully, we’ll deliver more patient-relevant data and start designing studies to gather data that the patients want us to gather.”