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Review
. 2023 Aug;16(8):1323-1330.
doi: 10.1111/cts.13533. Epub 2023 May 8.

Digital technologies: Innovations that transform the face of drug development

Elena S Izmailova  1 , Bilal AbuAsal  2 , Hazem E Hassan  3 , Anindita Saha  4 , Diane Stephenson  5
Affiliations
Review

Digital technologies: Innovations that transform the face of drug development

Elena S Izmailova et al. Clin Transl Sci. 2023 Aug.

Abstract

Recently, digital health technologies (DHTs) and digital biomarkers have gained a lot of traction in clinical investigations, motivating sponsors, investigators, and regulators to discuss and implement integrated approaches for deploying DHTs. These new tools present new and unique challenges for optimal technology integration in clinical trial processes, including operational, ethical, and regulatory issues. In this paper, we gathered different perspectives to discuss challenges and perspectives from three different stakeholders: industry, US regulators, and a public-private partnership consortium. The complexities of DHT implementation, which include regulatory definitions, defining the scope of validation experiments, and the need for partnerships between BioPharma and the technology sectors, are highlighted. Most of these challenges are related to translation of DHT-derived measures into endpoints that are meaningful to clinicians and patients, participant safety, training, and retention and privacy of data. The example of the Wearable Assessments in the Clinic and Home in PD (WATCH-PD) study is discussed as an example that demonstrated the advantages of pre-competitive collaborations, which include early regulatory feedback, data sharing, and multistakeholder alignment. Future advances in DHTs are expected to spur device-agnostic measured development and incorporate patient reported outcomes in drug development. More efforts are needed to define validation experiments for a defined context of use, incentivize data sharing and development of data standards. Multistakeholder collaborations via precompetitive consortia will help facilitate broad acceptance of DHT-enabled measures in drug development.

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Conflict of interest statement

E.S.I. is an employee of Koneksa Health and may own company stock. H.H. is an employee of Regeneron Inc. and may own company stock. All other authors declared no competing interests for this work.

Figures

FIGURE 1
FIGURE 1
Unique benefits of digital health technologies use in clinical investigations.
FIGURE 2
FIGURE 2
Regulatory considerations for DHT derived measures. COA, clinical outcome assessment; DHT, digital health technology.
FIGURE 3
FIGURE 3
Public‐private partnerships consortia role in advancing digital health technology enabled measures.
See this image and copyright information in PMC

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