Real-World Evidence and the Transformational Role of Digital Health

Baltimore, MD, USA—May 21, 2018—ISPOR, the professional society for health economics and outcomes research, opened its ISPOR 2018 conference in Baltimore, MD, USA this morning with the first plenary session, “Inflection Point for Real-World Evidence? The Transformational Role of Digital Health.”

Real-world evidence (RWE) offers the potential to provide healthcare information, previously only available through randomized clinical trials (RCTs), at a lower cost, with higher quality, in near real-time, and with the ability to better study specific patient characteristics (eg, age, gender, ethnicity, comorbidities). Helping to fuel the growth of RWE has been the exponential increase of digital health data over the past 10 years, including electronic health records (EHRs), claims, billing, and patients’ device-generated data. This panel, comprised of leaders who have been working on cutting-edge initiatives in this arena, shared their learnings, current barriers to the use of RWE, and what they believe the future holds for the transformational role of digital health around the world.

Rachael L. Fleurence, PhD, National Evaluation System for Health Technology Coordinating Center, Arlington, VA, USA moderated the panel. Panelists included Adrian F. Hernandez, MD, MHS, Duke University School of Medicine, Durham, NC, USA; Michelle McMurry-Heath, MD, PhD, Johnson & Johnson Medical Device Companies, Washington, DC, USA; Danica Marinac-Dabic, MD, PhD, MMSc, US Food & Drug Administration, Silver Spring, MD, USA; and Sally Okun, RN, MMHS, PatientsLikeMe, Cambridge, MA, USA.

Ms Okun believes that we are at an inflection point for real-world evidence. She noted, however, that we may need a new and different definition for real-world data that incorporates the patient perspective. She pointed out that engaged and empowered patients can play a transformational role in healthcare. Ms Okun concluded by noting that while the potential power of ubiquitous data is significant, it is important to remember that this data represents the lives of real people.

Dr McMurry-Heath believes that time is of the essence for real-world evidence because it can answer critically important questions in healthcare, such as how existing health technologies are performing in the real world and which new health technologies are safe and effective so they can be brought to market sooner for the patients who need them. She suggested that the patient value proposition around real-world data should change because of the immediate value this data can have for patients.

Dr Marinac-Dabic pointed out that when focusing on digital health it is important to focus on the continuity of the evidence. She sees a future that involves public and private partnerships working together. She also noted that in this digital world, safety and innovation are more closely related than ever.

Dr Hernandez pointed out that most people live their lives outside of the hospital and the healthcare system—information that can now be captured as real-world data. He believes that the future of real-world evidence depends on transparency and privacy to maintain the public trust.

Additional information on ISPOR 2018 can be found here. Released presentations from the conference can be found here. Interested parties can follow news and developments from the conference on social media using the hashtag #ISPORBaltimore.



ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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