Solve Clinical Trial Enrollment Struggles With Better Utilization of Healthcare Data
Real world data (RWD) and electronic health record (EHR) data hold immense potential for modernizing clinical trials, from using EHR data to accelerate patient enrollment to leveraging RWD all the way down the care continuum. But we must first build foundational collection and analysis infrastructure to ensure EHR data are clean, normalized, and handled well enough to maximize its impact in patient’s lives.
Solve Clinical Trial Enrollment Struggles With Better Utilization of Healthcare Data, the first roundtable in the Elligo Elite Learning Series, is a deep dive into the world of clinical research and EHR data. Featuring industry experts offering their unique experiences and perspectives, this exclusive discussion unfolds in four parts: background on EHR data, RWD, and the FDA’s regulatory work in these areas; the exciting innovations EHR data present for clinical trials; the potential pitfalls of using EHR data in research; and possible solutions for overcoming these pitfalls.
EHR Data, RWD, and the FDA
The FDA Real World Evidence Program, which began in 2016, offers guidance on the use of RWD in supporting new indications for approved drugs and satisfying post-approval study requirements. How has the program evolved since its inception, and how will these changes impact the use of EHR data and RWD in clinical research?
Mitra Rocca, Dipl.-Inform. Med., FAMIA, Senior Medical Informatician, FDA, leads this part of the webinar, providing background and insights based on her years of experience in the FDA and clinical research.
How EHR Data Can Modernize Clinical Research
From accelerating clinical trial enrollment and increasing diversity in clinical trial participation to streamlining protocol design and implementation, enabling precision medicine, and delivering postmarket value and improving existing devices, EHR data has the potential to catapult clinical research into innovation.
Riley Ennis, Chief Product Officer, Freenome, and Dr. TJ Bowen, Chief Scientific Officer & Co-Founder, Deep Lens, explore the many ways RWD and EHR data are already revolutionizing clinical research as well as the exciting possibilities they hold for the future.
The Challenges EHR Data Present in Research Use
EHR data was not created for research purposes, but rather for use in clinical care and billing. As such, it’s often inconsistent in quality and sample size and requires significant time and effort in cleaning and validation.
With an impressive background in real world evidence and advanced big data analytics, Jeremy Brody, Head of Global Strategy, Cerner Enviza, provides insight into the challenges clinical research faces when it comes to using RWD and EHR data.
Overcoming EHR Challenges to Bring Clinical Research Into the Future
What are some solutions on cleaning up RWD and EHR data for clinical research? How can we bring study data back into electronic medical records for patient care and as a technical solution?
Michael Ibara, Pharm.D., Chief Data Officer, Elligo Health Research®, leads the discussion in actionable solutions and electrifying ideas for overcoming the challenges EHR data present so we can better utilize it for the benefit of patients, physicians, and sponsors.
Join the Elligo Elite Learning Series
For further insights into the future of EHR data in clinical research, watch the recording of the first Elligo Elite Learning Series roundtable.