Speakers
Lesley Curtis, PhD
Professor in Population Health Sciences
Department of Population Health Sciences
Duke University School of Medicine
Bradley Hammill, DrPH
Associate Professor in Population Health Sciences
Department of Population Health Sciences
Duke University School of Medicine
Sudha Raman, PhD
Assistant Professor in Population Health Sciences
Department of Population Health Sciences
Duke University School of Medicine
Topic
Leveraging RWD in a Multinational Trial: Results from the Other eHARMONY (HARMONY Outcomes EHR Ancillary Study)
Keywords
Electronic health records; eHARMONY; Real-world data; DataMart; Common data model; Data sensitivity/specificity
Key Points
- While the electronic health record (EHR) is a rich source of clinical data, the fitness of EHR data for use in high-quality clinical research has not been rigorously evaluated.
- The HARMONY trial aimed to determine the effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in patients with type 2 diabetes mellitus. eHARMONY was an ancillary study conducted alongside the HARMONY trial, with these objectives:
- Understand how EHR data are used to facilitate trial recruitment and what the barriers are to that use
- Evaluate the fitness of real-world data (RWD) data for use in populating baseline characteristics in the electronic case report form
- Evaluate the fitness of RWD data for use in identifying clinical endpoints
- In the eHARMONY study, assessing data quality and fitness of a site’s EHR data was often not possible. Among the lessons learned were:
- Each strategy required ongoing feasibility assessment
- Standalone clinical research sites had very little (extractable) EHR data about patients
- Lab results and medications were either not extractable or not mapped to a useful terminology
- Many sites did not participate because they knew they could not perform this work, and many sites that promised to do this work could not deliver
Discussion Themes
What structural and behavioral factors have you encountered? For example, a healthcare system might not provide a particular service, or a healthcare system provides the service but people might choose to receive it elsewhere.
What about the overall cost of the trial? Has anything changed over the last 5 years—or are we consigned to spend hundreds of millions on outcome trials?
To realize the potential of real-world data in clinical trials, be mindful of the actual context of the trial, and (1) keep it simple, (2) collect only the data you need for the question at hand, and (3) remember that clinical research is not the priority for healthcare systems.
It is also essential for studies to report what does not work.
Read more about how real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.
Tags
#pctGR, @Collaboratory1