Clinical Researcher—February 2020 (Volume 34, Issue 2)
RECRUITMENT & RETENTION
Henry Anhalt, DO
In the world of diabetes, researchers have discovered that diabetes drugs have cardiovascular implications. The U.S. Food and Drug Administration (FDA) wants long-term follow-up studies to ensure safety—the virtual study model is perfect for that.
It was only a decade ago that the FDA issued guidance to ensure that new diabetes drugs were not associated with an unacceptable increase in cardiovascular risk. Given the high prevalence of cardiovascular disease in those with diabetes, there was a lack of understanding of how diabetes drugs contributed to major adverse cardiac events (MACEs).
Fast forward to now, and technology has ushered in methods that can help us gain a better understanding of how diabetes drugs impact the cardiovascular system in real-world settings. Chief among these new methods are virtual studies.
RCTs are Not Enough
As research has shown, understanding how diabetes treatments work in the real world has significant importance for patients, providers, and beyond. Unfortunately, we cannot rely on traditional randomized controlled trials (RCTs) alone to yield this type of data, because their closely monitored—some would say artificial—conditions are not necessarily reflective of how patients use the treatments in real life.
One area where technology has been a boon for researchers and patients alike is in providing patient-reported outcomes that are more reflective of real-world conditions. Imagine having to remember episodes of low blood glucose levels for your next study phone call or annual physical. For many people, it’s difficult enough remembering what was for dinner last Thursday. Luckily, some of the endpoints the FDA is looking for can be captured more predictably, and passively, with a wearable device or an app.
Digital technology has enabled the passive capture of metrics such as hours of sleep, heart rate, and physical activity; a device can automatically report these statistics as well as send patients reminders for medication times, scheduled telemedicine visits, etc. Thus, a virtual approach can capture a broader set of outcomes than traditional methods.
Virtual studies also amplify the convenience for patients, including the ability to provide electronic consent to participate in research and experience study visits from the comfort of home using telemedicine. The added convenience is often a key factor in patient retention; patients can go on with their lives without traveling to a research center potentially hundreds of miles away.
Reaching Out to Underrepresented Populations
Another driver for the healthcare community and the FDA is capturing data for the populations most affected by diabetes: communities of color. For example, Mexican-American and Puerto Rican communities have a diabetes prevalence rate that is twice that of their white counterparts, yet they make up 4% of diabetes study participants. African-Americans are significantly more likely to have diabetes and twice as likely to die from it than whites, yet they remain underrepresented in research.
Moving care from the clinic to a patient’s home enables a more diverse group of people to participate in research—this is especially the case for diabetes, with its various comorbidities, which may make traveling to a clinic more difficult.
Virtual studies can unlock a trove of real-world data that can help determine how diabetes drugs affect the cardiovascular system over the long term. Researchers are able to capture more and different data points outside the confines of a tightly controlled RCT. The FDA wants this long-term follow-up data, and those in the virtual clinical trial space know that it can pave the way for more effective therapies and better patient outcomes.
With the aid of technology, virtual trials can provide the data that FDA is looking for at the same time as delivering better care to our patients.
Henry Anhalt, DO, is Vice President of Medical Affairs for Science 37, serving as lead physician for the company’s diabetes, metabolism, and endocrinology research unit, among other duties.