دورية أكاديمية
Unlocking the full potential of digital endpoints for decision making: a novel modular evidence concept enabling re-use and advancing collaboration.
| العنوان: | Unlocking the full potential of digital endpoints for decision making: a novel modular evidence concept enabling re-use and advancing collaboration. |
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| المؤلفون: | Leyens L; Regulatory Science, DEEP Measures Oy, Helsinki, Finland.; Product Development Regulatory, F. Hoffmann-La Roche Ltd, Basel, Switzerland., Batchelor J; Regulatory Science, DEEP Measures Oy, Helsinki, Finland., De Beuckelaer E; Quality, Janssen Pharmaceutica N.V, Beerse, Belgium., Langel K; Regulatory, Janssen Cilag S.A, Madrid, Spain., Hartog B; Clinical Operations and Innovation, Janssen-Cilag B.V, DS Breda, The Netherlands. |
| المصدر: | Expert review of pharmacoeconomics & outcomes research [Expert Rev Pharmacoecon Outcomes Res] 2024 Jul; Vol. 24 (6), pp. 731-741. Date of Electronic Publication: 2024 May 15. |
| نوع المنشور: | Journal Article; Review |
| اللغة: | English |
| بيانات الدورية: | Publisher: Taylor & Francis Country of Publication: England NLM ID: 101132257 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1744-8379 (Electronic) Linking ISSN: 14737167 NLM ISO Abbreviation: Expert Rev Pharmacoecon Outcomes Res Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2015- : Abingdon, Oxford : Taylor & Francis Original Publication: London : Future Drugs Ltd, [2001- |
| مواضيع طبية MeSH: | Technology Assessment, Biomedical*/methods , Endpoint Determination*, Humans ; Cooperative Behavior ; Decision Making ; Drug Industry/organization & administration ; Digital Technology ; Precision Medicine/methods ; Biomedical Technology/methods ; Delivery of Health Care/organization & administration |
| مستخلص: | Introduction: Over the last decade increasing examples indicate opportunities to measure patient functioning and its relevance for clinical and regulatory decision making via endpoints collected through digital health technologies. More recently, we have seen such measures support primary study endpoints and enable smaller trials. The field is advancing fast: validation requirements have been proposed in the literature and regulators are releasing new guidances to review these endpoints. Pharmaceutical companies are embracing collaborations to develop them and working with academia and patient organizations in their development. However, the road to validation and regulatory acceptance is lengthy. The full value of digital endpoints cannot be unlocked until better collaboration and modular evidence frameworks are developed enabling re-use of evidence and repurposing of digital endpoints. Areas Covered: This paper proposes a solution by presenting a novel modular evidence framework -the Digital Evidence Ecosystem and Protocols (DEEP)- enabling repurposing of measurement solutions, re-use of evidence, application of standards and also facilitates collaboration with health technology assessment bodies. Expert Opinion: The integration of digital endpoints in healthcare, essential for personalized and remote care, requires harmonization and transparency. The proposed novel stack model offers a modular approach, fostering collaboration and expediting the adoption in patient care. |
| فهرسة مساهمة: | Keywords: Digital endpoint; clinical research; clinical validation; digital health; digital health technology; patient focused drug development |
| تواريخ الأحداث: | Date Created: 20240515 Date Completed: 20240616 Latest Revision: 20240616 |
| رمز التحديث: | 20240617 |
| DOI: | 10.1080/14737167.2024.2334347 |
| PMID: | 38747565 |
| قاعدة البيانات: | MEDLINE |
PDF full text from Publisher | تدمد: | 1744-8379 |
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| DOI: | 10.1080/14737167.2024.2334347 |