Doctor examining images of a human body

DHTs (Digital Health Technologies) in Clinical Investigations

The FDA classifies biosensors as digital health technology (DHT) which is a system that uses computing platforms, connectivity, software, and/or sensors for health care and related uses1. Biosensors are most often seen as wearable health technology/wearable sensors. One common example of wearable sensor technology are personal fitness watches like Apple and Fitbit. But biosensor use isn’t just limited to personal fitness watches, they are also used in clinical investigations to capture data and endpoints, as well as monitor the patient’s health.

Biosensors have become increasingly integral in clinical investigations, offering precise real-time monitoring of various biological parameters. In 2019, approximately 15% of trials incorporated wearable devices, primarily to collect data as explanatory endpoints and monitor patients’ health2. Currently, the percentage of clinical investigations reporting the use of wearables biosensors as primary or secondary endpoints on is less than 1%. Though usage is low now, it is anticipated that up to 70% of clinical investigations will incorporate wearable sensors by 20253.

Depending on the intended use of the DHT, the DHT may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act (FD&C Act)4. If a DHT meets the definition of a medical device, developers and stakeholders must now consider and include information regarding DHTs in their regulatory submission (i.e. IND, IDE, DDT submission, MDDT submission).

There are many applications of biosensors in clinical investigations, ranging from assessing drug efficacy and safety to monitoring patient response and disease progression. When used as endpoints, they function as a powerful tool for enhancing the efficiency, accuracy, and patient-centricity of clinical investigations. Due to their flexible application and benefits they offer, we can see why biosensors are being increasingly used in clinical investigations.