Unlocking the full potential of digital endpoints for decision making: a novel modular evidence concept enabling re-use and advancing collaboration

Author:

Leyens Lada12,Batchelor John1,De Beuckelaer Erwin3,Langel Kai4,Hartog Bert5

Affiliation:

1. Regulatory Science, DEEP Measures Oy, Helsinki, Finland

2. Product Development Regulatory, F. Hoffmann-La Roche Ltd, Basel, Switzerland

3. Quality, Janssen Pharmaceutica N.V, Beerse, Belgium

4. Regulatory, Janssen Cilag S.A, Madrid, Spain

5. Clinical Operations and Innovation, Janssen-Cilag B.V, DS Breda, The Netherlands

Publisher

Informa UK Limited

Reference66 articles.

1. Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges

2. National Academies of Sciences, Engineering, and Medicine; Health and Medicine; Division; Board on Health Sciences Policy; Roundtable on Genomics and Precision Health; Forum on Drug Discovery, Development, and Translation.The Role of Digital Health Technologies in Drug Development: Proceedings of a Workshop. Shore C, SH B, Nicholson A, Addie S, Hackmann M, Khandekar E, editors. Washington (DC): National Academies Press (US); 2020 Aug 28. PMID: 32870622.

3. Illuminating the dark spaces of healthcare with ambient intelligence

4. European regulators’ views on a wearable-derived performance measurement of ambulation for Duchenne muscular dystrophy regulatory trials

5. Mapping Relevance of Digital Measures to Meaningful Symptoms and Impacts in Early Parkinson’s Disease

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