Beyond Drug Development:
The Increasing Role of Real-World Data and
Real-World Evidence in Medical Research
Thursday, April 25th, 2:00pm - 3:00pm EDT
The digitalization of the US healthcare system, driven by the 2014 “Meaningful Use” legislation, makes real-world data (RWD) almost infinitely available and allows the analysis of vast information representing actual medical practice. However, studies using RWD have not yet achieved the level of credibility and sophistication like randomized clinical trials (RCT) with their very detailed guidelines and regulations. The two major sources for RWD in medical research are Electronic Medical Records (EMR) and insurance “claims data”. Both data sources have their limitations in completeness, quality, and longevity.

This webinar will

  • Discuss strengths and limitations of data
  • Introduce methodologies
  • Demonstrate how RWD/RWE can answer vital questions for which RCT would be too time-comsuming, less gereralizable, or too costly for an individual sponsor
  • Present options that ensure a robust evolution from RWD to real-world evidence (RWE)

Various use cases for RWD in medical research and drug development will be presented.


David Thompson, PhD
Senior Vice President, Real World Research for Syneos Health

Dave is a health economist by training with 25+ years of experience conducting real-world research and consulting for clients in the biopharmaceutical sector.

Dave is Editor-in Chief of ISPOR's publication, Value & Outcomes Spotlight, a position he has held since 2008, and serves on the advisory board of the Duke-Margolis Real-World Evidence Consortium.

Manfred Stapff, MD, PhD
Chief Medical Officer, TriNetX

Manfred Stapff is a physician and board-certified clinical pharmacologist with an extensive career in clinical and pharmaceutical medicine. He worked in US and international settings in leadership positions at Actavis, Forest Laboratories and Merck and served as a Medical Officer in the German Air Force.

His publication list includes papers and books about drug development, project management, clinical and real-world data studies in various therapeutic areas. Manfred earned his MD and PhD from Ludwig Maximilian University of Munich.

Sponsored by:

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