We here at Novela are staunch supporters of real-world data (RWD) and real-world evidence (RWE). For those new to the concepts, RWD and RWE are similar in that they come from real patients in real-world settings.
Even the FDA is onboard. Since 2016 with the passing of the 21st Century Cures Act, the FDA has placed additional focus on the use of these data to support their decision-making process, such as the approval of new uses (“indications”) for drugs already on the market. Both RWD and RWE are “playing an increasing role in health care decisions,” writes the FDA.
With nEureka®, our goal is to bring the power of RWD and RWE to epilepsy, a neurological condition that affects around 50 million people worldwide. However, epilepsy remains difficult to treat for any single individual, often requiring months–if not years–of trial-and-error. Part of the reason is that epilepsy is highly heterogeneous, and neuroscientists don’t yet fully understand the neurobiological processes behind each type for any given person.
We are not alone in our vision for a transformative future for patient care with chronic neurological. This week, two MIT researchers published an opinion piece in the highly prestigious neuroscience journal, Neuron, supporting our vision. “ Faster, more reliable, and comfortably wearable personal devices are producing data from biosensors on an unprecedented scale. Combined with context and analytics, these signals hold great promise to advance neuroscience via real-world data,” writes Drs. Kristina Johnson and Rosalind Picard.
What is RWD and RWE?
RWD generally includes data gathered from “patient health status and/or the delivery of health care routinely collected from a variety of sources,” such as electronic health records or patient-generated data including home-use settings. For example, self-reported seizure or medication tracking data from home fall into this category.
RWE, on the other hand, goes one step further in that it is the analysis of RWD to gain clinical evidence for the usage and potential benefits or side effects of a health or medical product. For example, data gathered from nEureka®, with full consent from patients and anonymized, can help scientists begin to tease out whether a certain medication works differently depending on a person’s age, gender, general health status in addition to seizure type.
Why is RWE Becoming a Critical Aspect of Health Care?
RWE works similarly to scientific studies, in that it is the result of careful unbiased analysis of data, but from the real-world. Similar to clinical trial evidence, there are many different scientific means to analyze these data, such as randomization, to ensure the conclusions are unbiased and informative.
However, RWE from wearables data is especially powerful:
First, compared to clinical trials, RWD from wearables is magnitudes higher in scale. “Wearable technology is booming, rapidly evolving from a niche market to an industry that is estimated to earn USD $54 billion by 2023 (2020 Global Data Report),” said the MIT team. The boom in affordable consumer wearables has generated a deluge of health data, from heart health to activity levels to sleep, to the benefit of health research. However, so far most wearables are focused on the average consumer. nEureka® seeks to bring that advance to the epilepsy community, with a system tailored specifically to the needs of people with epilepsy and their caregivers.
Second, unlike lab equipment, wearables are comfortable and non-intrusive. It’s perhaps not surprising that the “rapid growth in adoption of wearables is largely being driven by smartwatches,” the MIT team wrote. Because they are small and integrate easily into daily lives, it makes it possible to perform longitudinal studies over years, or in populations traditionally underrepresented in neuroscience. Compared to functional MRI and other neuroimaging equipment, wearables are also magnitudes less expensive.
Of course, smartwatches cannot scan the brain. However, built-in sensors such as heart rate, sleep-wake cycles, gait, blood oxygen levels or breathing rate are all proxies into the function of certain brain circuits. For now, deciphering how RWD from these sensors singularly or combined reflect the brain’s function is still an ongoing research challenge for the neuroscience community. But if successful, the rewards are plenty: for example, it may finally be possible to use biomarkers to accurately detect–or even predict–multiple types of seizures.
To be clear: the neuroscience isn’t there yet. But RWD and RWE paves a road towards making it possible. With nEureka®, we hope to support the effort to advance epilepsy research with RWE, to the benefit of patient healthcare.