While traditional endpoints and biomarkers are still necessary for FDA submission and regulation, the advent of digital tools has presented the opportunity to revolutionize the data capture method — specifically, the ability to collect more specific, relevant data points or digital biomarkers.
According to Rock Health’s report The Emerging Influence of Digital Biomarkers on Healthcare, digital biomarkers are “consumer-generated physiological and behavioral measures collected through connected digital tools” which “represent an opportunity to capture clinically meaningful, objective data in a cost-effective manner.”
In today’s regulatory environment, digital endpoints or digital biomarkers provide researchers supplemental, contextual information to arrive at a Go/No Go decision in a clinical trial more confidently and efficiently. The additional data wearable sensors and novel metrics provide, which may go unseen by traditional endpoints, can warn of a likely phase III failure. And according to the Biotechnology Innovation Organization, only 58% of expensive, lengthy phase III clinical trials succeed.
Here’s what you need to know about the use of digital endpoints and digital biomarkers in clinical trials.
In a traditional clinical trial setting, a subject will travel to the clinic every two to four weeks to undergo a series of tests designed to measure the effectiveness of a therapy. During each visit, a physician or researcher will assess the subject’s ability to perform tasks like a Timed Up and Go or a Six Minute Walk Test. This evaluation will continue for about three to eight months and yields the traditional endpoints and biomarkers required for FDA submission and regulation.
Using wearable sensors, however, allows researchers to longitudinally capture objective data throughout a subject’s daily life, instead of subjectively assessing a subject’s progress at intermittent appointments.
Digital tools capture data at a much greater convenience to subjects, who can wear small devices in the comfort of their own home and maintain their daily routine. Since subjects are moving naturally and without the stress of performing in a clinical environment under the observation of a physician, researchers can acquire more accurate data.
Wearables can capture biomarkers like median standing and sleeping time, and metrics on gait and balance. For more precise insights, researchers can develop disease-specific algorithms to process subject data. For example, data collected throughout a subject’s average day can be processed by tailored algorithms to quantify the severity and progression of symptoms like dyskinesia, tremor, and Parkinson’s shuffle.
As digital endpoints continue to undergo validation and yield effective results, pharmaceutical and medical device companies can work towards a future where these outcomes can replace traditional in-clinic endpoints for FDA submission and therapeutic regulation.