September 6, 2019: Transforming Medical Evidence Generation with Technology-Enabled Trials (Matthew T. Roe, MD MHS)


Matthew T. Roe, MD, MHS
Senior Investigator, Professor of Medicine
Duke Clinical Research Institute


Transforming Medical Evidence Generation with Technology-Enabled Trials


Mobile clinical trials; Real-world evidence; Real-world data; Study design; Regulatory oversight; Digital health; Mobile health applications; Biosensors; Electronic health records

Key Points

  • Digital health applications and electronic health records provide tremendous opportunities for improving trial efficiencies, broadening patient participation, and reducing cost.
  • Novel approaches that can help reduce data collection burden for study sites include importing EHR data directly into the trial database, collecting patient-reported outcomes through web-based portals, and incorporating digital health data from wearables and biosensors.
  • To realize the potential of new technology, cross-sectional partnerships are needed among research participants, researchers, biopharma device industries, professional medical associations, insurers, FDA, clinicians, health IT, contract research organizations, and health systems.

Discussion Themes

How many potential patients might we lose if having a smart phone is an inclusion criterion for a clinical study?

How can we ensure that the clinical trial infrastructure is inclusive of minority populations, especially those in rural settings?

What is the role of physicians in reaching a large number of participants who are not near an academic research center?

Ultimately, in clinical trials, the data are what matter and what decisions are based on. We need to understand data quality and standards for the data to be accepted.

Read more about digital health at FDA’s Digital Health website.


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