Digital endpoints have the potential to revolutionize clinical trials by providing real-time data collection, enhancing patient engagement, improving efficiency, and reducing costs. These new forms of data points are assessed using data captured by a sensor, typically outside of a clinic during daily living activities. The sensor can be worn like a pedometer in a smartwatch used to capture motion data, or ingested like a pH sensor in a digital pill used to capture acidity in the digestive tract. It can also be part of a remote sensor system, such as a microphone in smartphones used to capture voices. The integration of these digital health technologies into research not only offers researchers more comprehensive and accurate insights but also empowers patients to actively participate in their own healthcare.
Using and contributing to digital endpoint libraries allows for others to learn what digital measures and tools are being used in industry-sponsored trials. It also shines a light on digital measures already being included in industry-sponsored trials, providing a strong signal of where digital endpoints may be most valuable in drug development.
A key development in digital endpoints
Recent studies of diseases related to the central nervous system have shown a rise in the use of trackers and wearable sensors. Activities of patients in real-time and as they go about their daily routines are monitored, as opposed to staged settings.
Diagram Showing how Digital Data can Change the Landscape for Patient Care in the Future
[Image Source: Journal of Neuromuscular Diseases]
What are the potential drawbacks?
While the use of digital endpoints offers numerous benefits, it also raises ethical and privacy concerns. Researchers need to ensure that participants’ privacy and data security are protected throughout trials. Adequate measures should be in place to safeguard personal health information, adhere to applicable regulations, and obtain informed consent from participants for data collection and usage. It is essential to address ethical considerations and data privacy concerns; ensuring the responsible and secure use of digital endpoints.
Despite uncertainties and implementation barriers, experts say the number of validated digital endpoints is likely to jump in the coming years. A recent report by PWC predicts that sponsors “willing to invest in strengthening or building digital competencies may win market share, while those without sufficient investments may find themselves at a disadvantage.”
Moving forward: The future of digital endpoints
Clinical trials play a crucial role in advancing medical research and finding new treatments for various diseases; however, the traditional methods of conducting clinical trials are often time-consuming, expensive, and can have limitations in capturing real-time patient data. The emergence of digital endpoints in clinical trials has the potential to revolutionize the way research is conducted, enabling more efficient and accurate data collection, enhancing patient engagement, and ultimately accelerating the development of life-saving therapies.