Regulatory considerations to keep pace with innovation in digital health products
Rapid innovation and proliferation of software as a medical device have accelerated the
clinical use of digital technologies across a wide array of medical conditions. Current …
clinical use of digital technologies across a wide array of medical conditions. Current …
Decentralized clinical trials and rare diseases: A drug information association innovative design scientific working group (DIA-IDSWG) perspective
M Ghadessi, J Di, C Wang, K Toyoizumi… - Orphanet Journal of …, 2023 - Springer
Background Traditional clinical trials require tests and procedures that are administered in
centralized clinical research sites, which are beyond the standard of care that patients …
centralized clinical research sites, which are beyond the standard of care that patients …
A consensus statement for continuous glucose monitoring metrics for inpatient clinical trials
EK Spanakis, CB Cook, K Kulasa… - Journal of diabetes …, 2023 - journals.sagepub.com
Diabetes Technology Society organized an expert consensus panel to develop metrics for
research in the use of continuous glucose monitors (CGMs) in a hospital setting. The experts …
research in the use of continuous glucose monitors (CGMs) in a hospital setting. The experts …
Individual-specific change points in circadian rest-activity rhythm and sleep in individuals tapering their antidepressant medication: an actigraphy study
Group-level studies showed associations between depressive symptoms and circadian
rhythm elements, though whether these associations replicate at the within-person level …
rhythm elements, though whether these associations replicate at the within-person level …
Increasing the value of digital phenotyping through reducing missingness: a retrospective review and analysis of prior studies
Background Digital phenotyping methods present a scalable tool to realise the potential of
personalised medicine. But underlying this potential is the need for digital phenotyping data …
personalised medicine. But underlying this potential is the need for digital phenotyping data …
Unleashing the full potential of digital outcome measures in clinical trials: eight questions that need attention
MS Tackney, JR Carpenter, SS Villar - BMC medicine, 2024 - Springer
The use of digital health technologies to measure outcomes in clinical trials opens new
opportunities as well as methodological challenges. Digital outcome measures may provide …
opportunities as well as methodological challenges. Digital outcome measures may provide …
[HTML][HTML] The Importance of Data Quality Control in Using Fitbit Device Data From the All of Us Research Program
Wearable digital health technologies (DHTs) have become increasingly popular in recent
years, enabling more capabilities to assess behaviors and physiology in free-living …
years, enabling more capabilities to assess behaviors and physiology in free-living …
Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study
EI Nebie, HN Sawadogo, P van Eeuwijk, A Signorell… - BMJ open, 2023 - bmjopen.bmj.com
Introduction Digital health has gained traction in research and development, and clinical
decision support systems. The COVID-19 pandemic accelerated the adoption of …
decision support systems. The COVID-19 pandemic accelerated the adoption of …
[HTML][HTML] Examining associations between smartphone use and clinical severity in frontotemporal dementia: proof-of-concept study
Background: Frontotemporal lobar degeneration (FTLD) is a leading cause of dementia in
individuals aged< 65 years. Several challenges to conducting in-person evaluations in …
individuals aged< 65 years. Several challenges to conducting in-person evaluations in …
Digital endpoints in clinical trials: emerging themes from a multi-stakeholder Knowledge Exchange event
MS Tackney, A Steele, J Newman, MC Fritzsche… - Trials, 2024 - Springer
Background Digital technologies, such as wearable devices and smartphone applications
(apps), can enable the decentralisation of clinical trials by measuring endpoints in people's …
(apps), can enable the decentralisation of clinical trials by measuring endpoints in people's …