In recent years, consumer and medical grade technologies have emerged at the forefront of a digital evolution sweeping drug development. These digital health technologies (DHT) play a critical role in studies past, present and future as industry looks to continuously improve the measurement of clinical outcomes.
DHTs provide opportunities to transform drug development by enabling the measurement of existing endpoints in new or possibly better ways or of new endpoints that have not previously been possible to assess. Improved measures via DHTs can allow for the capture of richer and more objective information on how patients function with measures that are more relevant to lived experiences. In addition, a novel digital endpoint (NDE) may enable promotional claims if used as the prespecified ranked endpoint in registrational studies. Because of opportunities such as this, many pharmaceutical companies are developing novel digital measures of health and disease to accelerate drug development, increase patient centricity, and support product differentiation.
Despite the opportunities, very few DHTs have received regulatory acceptance to measure clinical endpoints. The development of an NDE requires a multidisciplinary, multi-study approach with strategic planning and a regulatory-guided pathway to achieve regulatory and clinical acceptance. To address these challenges, TransCelerate’s Patient Technology Initiative recently published a paper in Digital Biomarkers on “Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations.” This paper presents a use case proposal to describe the process and considerations when developing and obtaining regulatory acceptance for an NDE to assess sleep in patients with Rheumatoid Arthritis (RA), and outlines the four things sponsors must ascertain when planning to develop an NDE.
This paper aims to showcase TransCelerate’s Novel Digital Endpoints team’s work in exploring how DHT implementation can improve the drug development process.
You can read more about how DHTs can improve clinical trials on TransCelerate’ s Patient Technology Solutions page.
By Michelle Crouthamel