Coming Soon

Study to Identify Meaningful Aspects of Health Connected to the Symptom of Nocturnal Scratching in Patients with Atopic Dermatitis

Atopic dermatitis is a condition that affects one’s skin and often manifests with red and itching skin, leading to an urge to scratch that further damages the skin.

The researchers from Digital Medicine Society (DiMe) and the project partners organizing this research study are interested in finding out more about scratching at night, how it affects patients’ life, and whether it should be more closely monitored and evaluated using digital technologies.

Deployment of Digital Technologies Measuring Nocturnal Scratch in Clinical Trials

Successful integration of digital measures in atopic dermatitis populations is scouted by processes and activities taking place when deploying these digital technologies to clinical research projects. The study sponsors, technology vendors, data managers, study sites, clinicians, participating patients and other parties engaged in the study execution need to adapt to new situations, circumstances and processes.

In this work, DiMe and the project partners articulate the pain points encountered by involved parties in the process of digital measurement deployment in clinical research, and offer actions and mitigations suitable to address these issues and pain points. Output of this work will be a toolkit of recommendations for best practices overcoming identified challenges.

Toolkit Deliverables

• Case study: Defining value and identifying benefits of integrating digital measurement of nocturnal scratch to clinical studies
• Considerations document to support endpoint strategy for clinical trial utilizing digital measurement of nocturnal scratch
• Study population considerations for clinical trial design utilizing digital measurement of nocturnal scratch
• Project charter template for clinical studies utilizing digital measurement of nocturnal scratch
• Patient usability form for uniform usability testing across devices measuring nocturnal scratch
• Technology performance checklist for devices measuring nocturnal scratch
• Technology validation checklist for devices measuring nocturnal scratch
• Vendor selection considerations for clinical trial design utilizing digital measurement of nocturnal scratch
• Strategies to optimize site and investigator experience in clinical trial design utilizing digital measurement of nocturnal scratch
• Strategies to optimize atopic dermatitis patient experience in clinical trial design utilizing digital measurement of nocturnal scratch

Coming Soon

Coming Soon