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. 2025 Jul 31:27:e67052.
doi: 10.2196/67052.

Advancing the Integration of Digital Health Technologies in the Drug Development Ecosystem

Sakshi Sardar  1 , Cheryl D Coon  1 , Scottie Kern  1 , Huong Huynh  1 , Diane Stephenson  1 , Joshua Rubin Abrams  2 , Grace V Lee  1 , Cecile Ollivier  2 , Joseph A Hedrick  1 , Martijn Ltm Müller  1 , Luc J W Evers  3 , Lada Leyens  4   5 , Collin Hovinga  1 , Shu Chin Ma  1 , Klaus Romero  1
Affiliations

Advancing the Integration of Digital Health Technologies in the Drug Development Ecosystem

Sakshi Sardar et al. J Med Internet Res. .

Abstract

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.

Keywords: DHT; clinical research; digital health; digital health technologies; disease management; drug development; drugs; frameworks; technologies; viewpoints.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Overview of the needs for consensus-driven frameworks across the process flow for drug development tools. The figure shows the areas where collaborative work is needed to develop standardization and frameworks to support long-term, efficient integration of digital health technologies in the drug development ecosystems. The color scheme difference for certain elements is to highlight the applicability of a subcomponent framework to a major category represented by the bigger rectangle.
Figure 2
Figure 2
Overview of the areas for categorizing data standards. The figure represents a binning structure that can support data standard suits applicable for data needs related to concepts of interests and contexts of use, including biomarkers, clinical outcomes assessments, and models in various disease areas.
Figure 3
Figure 3
Overview of evidentiary requirement complexity. The figure shows the increasing complexity associated with the evidentiary requirements based on the type of fit-for-purpose sensing technology used for assessing biomarkers, clinical outcomes assessments, or fit-for-purpose models.
See this image and copyright information in PMC

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