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Clinical Trial Resources

Protokinetics: Improving objectivity in pediatric trials

Clinical Trials

Leveraging DATAcc by DiMe’s ontology for data transfer specifications development for early detection of CRS in CAR-T and BiTE therapy patients

Clinical Trials, Digital Measures Development Projects in Practice

Identifying and defining a remote, at-home assessment of visuospatial memory in ADRD

Clinical Trials, Digital Measures Best Practices

Empatica: Utilizing US data in Europe

Regulations, Clinical Trials

WELT: Navigating clinical trial comparators

Regulations, Clinical Trials

Huma: Clinical evidence transferability

Regulations, Clinical Trials

Big Health: Cross-jurisdictional recognition

Regulations, Clinical Trials

Oviva: Leveraging UK data in Germany

Regulations, Clinical Trials

Luca: Conducting clinical trials in China

Regulations, Clinical Trials

Sleep disruption discussion guide

Clinical Trials, Digital Measures Development Projects in Practice, Digitally enabled healthcare

Ontology of expressive communication

Regulations, Clinical Trials, Digital Measures Best Practices

Ontology of sleep disruption

Regulations, Clinical Trials, Digital Measures Best Practices

Ontology of non-sedentary behavior

Regulations, Clinical Trials, Digital Measures Best Practices

Core Digital Measures of ADRD conceptual model

Regulations, Clinical Trials, Digital Health Products

Standardized rationale for the use of the Core Digital Measures of ADRD

Clinical Trials, Digital Health Products, Digital Measures Best Practices

Visuospatial memory discussion guide

Clinical Trials, Digital Measures Development Projects in Practice, Digitally enabled healthcare

Expressive communication discussion guide

Clinical Trials, Digital Measures Development Projects in Practice, Digitally enabled healthcare

Non-sedentary discussion guide

Clinical Trials, Digital Measures Development Projects in Practice, Digitally enabled healthcare

Ontology of visuospatial memory

Regulations, Clinical Trials, Digital Measures Best Practices

5 innovative ways to bring DHTs to market successfully

Regulations, Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Digital Health Technologies for Alzheimer’s Disease and Related Dementias: Initial Results from a Landscape Analysis and Community Collaborative Effort

Clinical Trials, Digital Measures Best Practices

Assessing the Net Financial Benefits of Employing Digital Endpoints in Clinical Trials

Clinical Trials, Digital Measures Best Practices

The team at Boston University (BU) Chobanian & Avedisian School of Medicine include sleep as a core assessment area in their research across therapeutic areas.

Clinical Trials, Digital Health Products, Digital Measures Development Projects in Practice

Bayer Pharmaceuticals’ development portfolio often raises the question of sleep assessment as an important quality-of-life pillar of patients’ health, which can be positively affected by the new therapies.

Clinical Trials, Digital Health Products, Digital Measures Development Projects in Practice

Beacon Biosignals is a leader in sleep data analytics, and with the power of their Dreem headband, they are leaders in naturalistic sleep measurement at the brain activity level

Clinical Trials, Digital Health Products, Digital Measures Development Projects in Practice

TNO is a pioneering applied science and technology organization. Their mission is to create impactful innovations for the sustainable well-being and prosperity of society

Clinical Trials, Digital Health Products, Digital Measures Development Projects in Practice

Standardized Rationale for the Use of the Core Digital Measures of Sleep

Clinical Trials, Digital Measures Development Projects in Practice

Example Data Structure for the Core Digital Measures of Sleep

Clinical Trials

Core Measures: Sleep Measurement System

Clinical Trials

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Total sleep time

Clinical Trials

Core Digital Measure of Sleep: Total sleep time (Duration)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Frequently Asked Questions about Total Sleep Time

Clinical Trials, Digital Health Products

Checklist: Essential Questions for DHT Vendor Selection

Clinical Trials, Digitally enabled healthcare

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Initial sleep onset latency

Clinical Trials

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Number of wake events in the primary sleep period

Clinical Trials

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Sleep efficiency

Clinical Trials

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Total napping time

Clinical Trials

Comprehensive Checklist and Report Form for Core Digital Measures of Sleep: Wake after sleep onset

Clinical Trials

Conceptual model: Sleep Disturbance

Clinical Trials

Core Digital Measure of Sleep: Number of wake events in the primary sleep period (Count)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Core Digital Measure of Sleep: Total napping time (Duration)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Core Digital Measure of Sleep: Sleep efficiency (Percentage)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Core Digital Measure of Sleep: Wake after sleep onset (Duration)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

FAQ: Justifying the Inclusion of the Core Digital Measures of Sleep

Clinical Trials, Digital Health Products

Frequently Asked Questions about Sleep Onset Latency

Clinical Trials, Digital Health Products

Frequently Asked Questions about Sleep Onset (WASO)

Clinical Trials, Digital Health Products

Frequently Asked Questions about Number of wake events in the primary sleep period

Clinical Trials, Digital Health Products

Frequently Asked Questions about Sleep efficiency

Clinical Trials, Digital Health Products

Frequently Asked Questions about Total napping time

Clinical Trials, Digital Health Products

Systematic Literature Review of Qualitative Evidence of Sleep Disturbance

Clinical Trials

Scientific Figures of Sleep Disturbance

Clinical Trials, Digitally enabled healthcare

Narrative Review Objective Clinical Measures of Sleep in Real-World Settings

Regulations, Clinical Trials, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Snapshot of Sleep Library of Digital Measurement Products

Clinical Trials, Digital Health Products

Core Digital Measure of Sleep: Initial sleep onset latency (Duration)

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

V3+: An extension to the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

A systematic scoping review of studies describing human factors, human-centered design, and usability of sensor-based digital health technologies

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

Quickstart Guide: V3+ Use Specification

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

Quickstart Guide: V3+ Use-Related Risk Analysis

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

Checklist: Essential Questions for DHT Vendor Selection

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

At-a-Glance: Selecting Metrics for Evaluating sDHT Usability

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

At-a-Glance: Incorporating Human-Centered Design Into sDHT Development

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

The V3+ Usability Validation Glossary

Clinical Trials, Digital Health Products, Digital Health Equity, Digital Measures Best Practices, Digitally enabled healthcare

The Conceptual Model: A core set of digital measures for physical activity

Regulations, Clinical Trials, Digital Measures Best Practices

Mapping the Steps Forward: Decision tree for endpoint strategy for digital measures of physical activity

Clinical Trials, Digital Health Products, Digitally enabled healthcare

Capabilities Maturity Calculator

Clinical Trials, Digital Health Products, Digitally enabled healthcare

Decision tool: Integrating digital endpoint evidence into integrated evidence plans

Clinical Trials, Digital Health Products, Digital Measures Best Practices

Key Terms Glossary for 3Ps

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Opportunities and challenges to using digital clinical measures to inform reimbursement decisions in drug development

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Quick start guide to drug reimbursement – Europe

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Quick start guide to drug reimbursement – U.S.

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Recommendations for payers

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Recommendations for pharma

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Recommendations for payers at-a-glance

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Recommendations for pharma at-a-glance

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Using evidence from digital endpoints to demonstrate the value of a new drug: Considerations and recommendations

Payment, Clinical Trials, Digital Health Products, Digital Measures Best Practices

Case study: Defining value and identifying benefits of integrating digital measurement of nocturnal scratch to clinical studies

Regulations, Clinical Trials, Digital Health Products

Conceptual Model: Nocturnal Scratching in Atopic Dermatitis Patients

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Insights from the FDA

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Considerations to support endpoint strategy for clinical trials utilizing digital measurement of nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Vendor selection considerations for clinical trial design utilizing digital measurement of nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Value of a Successful Measure: Modeling Potential Increases in Drug Utilization

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Value of a Successful Measure: Translating Patient Value to Commercial Value

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Value of a Successful Measure: Key Insights and Action Items

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Terminology and ontology: “nocturnal”

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Terminology and ontology: “scratch”

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Technology performance considerations for selection of devices measuring nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Decision tree supporting endpoint strategy for clinical trials utilizing digital measurement of nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Evidence considerations for selecting digital tools for measuring nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Patient usability form for uniform usability testing of devices measuring nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Project charter template for clinical studies utilizing digital measurement of nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Quantitative Survey Results Dataset

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Recommendations for subject privacy assurance, data collection and study monitoring in clinical studies utilizing digital measurement of nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Strategies to optimize atopic dermatitis patient experience in clinical trial design utilizing digital measurement of nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Strategies to optimize site and investigator experience in clinical trial design utilizing digital measurement of nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Study population considerations for clinical trial design utilizing digital measurement of nocturnal scratch

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digital Measures Development Projects in Practice

Federal Comment Toolkit

Regulations, Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Expert Speaker Directory

Clinical Trials, Digital Health Products, Digital Measures Best Practices, Digitally enabled healthcare

Use the Market Opportunity Calculator

Clinical Trials, Digital Health Equity

Use Real-World Data and Real-World Evidence

Clinical Trials, Digital Health Equity