Posts about

digital endpoints

digital biomarkers, digital endpoints, wearables, regulated clinical trials, FDA guidance, digital clinical outcome assessments

Navigating the FDA DHT Guidance: Perspectives from Across the Industry

Digital health technologies (DHT) can collect objective, multi-dimensional data passively and...
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digital endpoints, fit-for-purpose, regulated clinical trials, DHT Operations, data quality, FDA guidance, AI

Planning Ahead: 5 Best Practices For The Integration of Wearables in Clinical Trials

Wearable, sensor-based digital health technologies (DHTs) can help biotech and pharma teams...
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digital biomarkers, digital endpoints, algorithms, wearables, regulated clinical trials, Parkinson's Disease, digital clinical outcome assessments

Address Unmet Measurement Needs in Parkinson’s Disease with Wearable DHTs

Clinical development is a challenging task. Clinical development in Parkinson’s disease (PD) faces...
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digital endpoints, sleep, usability, scratch, fit-for-purpose, real-world environment, regulated clinical trials, patient centricity

Evaluating Usability and Incorporating the Patient Experience in DECODE-Nocturnal Scratch

The Digital Endpoint Collaboration to accelerate Outcome DEvelopment (DECODE) Nocturnal Scratch...
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DiMe, clinical research, digital endpoints, sleep, scratch, real-world environment, regulated clinical trials, patient centricity

Developing a Patient-Centric Measure of Nocturnal Scratch: A Q&A with DiMe

The adoption of wearable Digital Health Technologies (DHTs) to measure outcomes of interest in...
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clinical research, digital endpoints, digital measure, wearables, digital transformation, regulated clinical trials, patient centricity

Perspective on the FDA's Final Digital Health Technologies Guidance

Regulatory guidance plays a pivotal role in shaping the ecosystem of clinical research and...
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clinical research, digital endpoints, digital measure, wearables, digital transformation, real-world environment, regulated clinical trials, patient centricity

Reflecting on a Year of Transformative Advancements in Digital Health

As we embark on another exciting year for the digital health landscape, I wanted to take a moment...
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actigraphy, digital endpoints, Data Science, medical-grade wearables, ActiGraph, fit-for-purpose, real-world environment, heart disease

Researching New Digital Measures in Heart Disease | DEAR Grant Profile

Cardiovascular diseases, according to the World Health Organization, are the leading cause of death...
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digital clinical measures, actigraphy, clinical research, digital endpoints, Data Science, DHT, medical-grade wearables, ActiGraph

Accelerate Clinical Development with Patient-Centric Digital Endpoints

Drug development success rates have been on the decline since 2015. Compounded by the pandemic,...
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actigraphy, virtual clinical trial, neurology, clinical research, digital endpoints, decentralized clinical trials, ALS

Paving the Way for Virtual Trials in Neurology: A Fully Remote ALS Study in 2015

The COVID-19 pandemic has completely changed the way we think about clinical research and care....
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polysomnography, actigraphy, neurology, clinical research, digital endpoints, RCT, sleep

Quantifying Sleep in the Real World

ActiGraph recently published a white paper presenting several examples of how wearables have been...
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