Advancing the Integration of Digital Health Technologies in the Drug Development Ecosystem (Preprint)

<sec> <title>UNSTRUCTURED</title> Optimized frameworks for efficient and scalable deployment of digital health technologies (DHT) are needed to address existing bottlenecks and unlock the opportunities for remote monitoring and operationalizing decentralized trials. DHTs offer immense potential opportunities for transformation in drug development by providing remote, high frequency, longitudinal insights into physiological processes, and how participants feel and function. Currently, DHT-based drug development tool–related efforts have yielded valuable insights into effective practices and areas that need improvement. However, the development of the required infrastructure is a resource-intensive task, and its efficiency can be greatly enhanced by systematically identifying the required components and aligning them in ways that will avoid trial-and-error approaches by various stakeholders. In this perspective paper, we aim to highlight these crucial aspects required for supporting the rapid and large-scale deployment of DHTs. We propose the development of various standardized consensus frameworks to clearly lay out processes for various stakeholders and facilitate the seamless integration of the next generation of health care–sensing technologies into drug development. </sec>