In a study evaluating the effectiveness of a drug designed to control heart rate, monitoring a subject’s pulse over a period of time will undoubtedly answer the primary question: Is the drug effective at controlling the patient’s heart rate?
While the answer to that primary question may be yes, researchers must consider what else happened while the patient was being treated with the drug. Perhaps the subject’s heart rate was well controlled, but the subject became more sedentary and less active. Or perhaps the subject experienced increased restlessness during sleep. The heart rate might be controlled, but that doesn’t mean the treatment is successful. Without the surrounding contextual data, comprehension of a subject’s response to treatment is incomplete.
As the U.S. healthcare system becomes increasingly outcomes-based and accountable, evaluating therapeutic efficacy requires researchers to consider the bigger picture of a subject’s health.
Obtaining Context Through Wearables and Apps
As Validic, the North Carolina-based provider of digital health data analysis solutions, points out, activity and sleep data collected by wearables can help trial sponsors to “uncover important patterns such as a participant being less active on days that a medication dose is missed or a participant sleeping more after taking the medication, indicating drowsiness as a possible side effect.” This contextual data also serves as a “useful indicator of behavioral health, providing researchers with a more objective means to understand how a participant may be feeling while taking a drug.”
Pharmaceutical companies are prioritizing contextual data and holistic approaches in clinical studies. Takeda Pharmaceuticals and Cognition Kit are “collaborating on a study to assess whether mobile apps and wearables with continuous monitoring capabilities can be used to glean new insights into major depressive disorder that could drive better treatment.”
The Cognition Kit app collects physiological data and evaluates cognition. MobiHealth News explains the study aims to “use continuous monitoring to catch under-recognized symptoms of major depressive disorder, thereby providing a more holistic view of the user’s mental health.”
They aren’t the only ones.
Monitoring Multiple Metrics
In Pfizer and IBM’s Project Blue Sky Initiative to study Parkinson’s progression with wearables, multiple metrics matter. “IBM and Pfizer aim to get a more holistic view of the patient by measuring a number of health metrics, including motor function, dyskinesia, cognition, sleep, and various daily activities,” MobiHealth News reports.
For GSK’s clinical trial leveraging Research Kit to study rheumatoid arthritis, the company focused on “asking patients the right questions.” CMO Murray Stewart told Clinical Leader, “Carrying that a step further, we also know rheumatoid arthritis patients can be prone to suffer from depression. Designing questions that deal with depression can also be recorded on the app and allow researchers to better understand the patients and data. This will help researchers to get a more holistic view of the health of a patient.”
Success is no longer measured by assessing if drugs and procedures do what they are supposed to, but by measuring whether or not the patient is better for it. Evaluating contextual data helps to measure therapy success through the lens of quality of life.