..., the validation requirements and regulatory acceptance pathways are distinct and different for each ( Fig. 1 ) [ 4, 15, 16 ]. Fig. 1. This diagram represents the different components and development stages of a digital endpoint in a clinical trial. COA, clinical outcome assessment; COI, concept of interest...

... such as Alzheimer’s disease. While most well-established measures for cognition might not fit tomorrow’s decentralized remote clinical trials, digital cognitive assessments will gain importance. We present the evaluation of a novel digital speech biomarker for cognition (SB-C) following the Digital Medicine Society’s...

... multidisciplinary teams, statisticians and data scientists are increasingly involved in clinical trials that incorporate digital clinical measures. They are called upon to provide input into trial planning, generation of evidence on the clinical validity of novel clinical measures, and evaluation of the adequacy...

...; Thomas Switzer; Liz Wing; Annemarie Forrest; Aiden Doherty Mobile technologies offer the potential to reduce the costs of conducting clinical trials by collecting high-quality information on health outcomes in real-world settings that are relevant to patients and clinicians. However, widespread use...

.... Clinical trials Digital health Evidence NODE Review Article Digit Biomark 2019;3:83 91 DOI: 10.1159/000500194 Received: October 24, 2018 Accepted: March 25, 2019 Published online: June 25, 2019 © 2019 The Author(s) Published by S. Karger AG, Basel www.karger.com/dib This article is licensed under...

... institutions that have established the Network of Digital Evidence for Health, NODE.Health, plus insights from existing clinical research taxonomies, syntheses or frameworks for assessing technology or for reporting clinical trials. 19 05 2018 4 10 2018 27 11 2018 © 2018 The Author(s...

..., including representatives from the US Food and Drug Administration, academia, the pharmaceutical industry, patient advocacy organizations, and mobile device experts [ 4 ]. Appendix 1 provides a com plete list of the search terms. The Clinical Trials Transformation Initiative (CTTI) is a public...