Digital technologies: Innovations that transform the face of drug development.

Autor: Izmailova ES; Koneksa Health, New York, New York, USA., AbuAsal B; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Hassan HE; Department of Pharmaceutical Sciences, University of Maryland, Maryland, Baltimore, USA., Saha A; Digital Health Center of Excellence, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USA., Stephenson D; Critical Path Institute, Tucson, Arizona, USA.
Jazyk: angličtina
Zdroj: Clinical and translational science [Clin Transl Sci] 2023 Aug; Vol. 16 (8), pp. 1323-1330. Date of Electronic Publication: 2023 May 08.
DOI: 10.1111/cts.13533
Abstrakt: 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.
(© 2023 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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