Real-World Data Presents Opportunities to Answer Questions About COVID-19

Last week, I had the pleasure of being invited to present at the monthly COVID-19 Evidence Accelerator, which is hosted by the Reagan-Udall Foundation for the FDA, the FDA, and Friends of Cancer Research. This month’s conversation was a continuation of an ongoing discussion about the impacts the pandemic has had and continues to have on mental health. 

I was honored to have the opportunity to talk through our initial findings from real-world data derived from our MindLinc electronic health record (EHR), which is used by mental health clinics across the U.S. We conducted a cross-sectional analysis of 4,904 patients before the pandemic and 2,917 patients during the pandemic, as well as a longitudinal analysis of a cohort of 8,880 patients before and during the pandemic. These analyses included patients regardless of COVID-19 infection status and showed some interesting insights. For example, we saw the number of hospital visits decrease during the pandemic (likely due to shelter-in-place restrictions) but no significant change in severity (which may be attributed to patients stabilizing over time).

What I found most interesting–and refreshing–about the hour we all spent together on Zoom is that leaders in our field are so energized about real-world data and its potential. Dr. Patrizia Cavazzoni, head of the FDA’s Center for Drug Evaluation Research (CDER), emphasized the importance of creating new endpoints for mental health. Current endpoints are limited to measurement scales used in clinical trials, but not in real clinical practice. By developing new endpoints, Dr. Cavazzoni said, we are opening the door to a better use of EHR data and claims data to find answers to challenging questions.

Dr. Joshua Gordon and Dr. Susan Borja of the National Institute of Mental Health (NIMH) drove home the importance of real-world data. They spoke about the lack of representative, good data to help us understand which people will need more intervention than others, and how real-world data can help to fill that gap.

Reyna Taylor from the National Council for Mental Wellbeing presented on the Certified Community Behavioral Health Clinic (CCBHC) model. This model is an example of how to provide individualized, person-centered care in the real world–and how we can use real-world data to achieve our goals centered around informed care.

It is encouraging to witness leaders of federal agencies placing real-world data at the epicenter of conversations, emphasizing its potential in future research–especially during the pandemic, a challenging environment  that has left us with more questions than answers. The mental health field is poised for the opportunities that real-world data can bring, and I look forward to using my role at Holmusk to continue these conversations and to drive forward momentum.