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Driving broad acceptance of digital measurement of nocturnal scratch as a high-value, trusted endpoint for atopic dermatitis by industry, patients, researchers, regulators and payers.

Digital Measures Development:
Nocturnal Scratch

Leading organizations developing and deploying digitally measured nocturnal scratch as a digital drug development tool have recognized that a pre-competitive collaborative approach will provide the most efficient and widely recognized path to resolve the challenges standing in the way to successful adoption of this measure.

Conducting and publishing research, cataloguing best practices and developing supporting resources in defined project areas of this project will support life sciences companies and the broader research and healthcare ecosystem to effectively gain acceptance for the tools being developed. It will lay the groundwork for future use of the measure in clinical research, technology development as well as reimbursement decisions to enhance the effectiveness, efficiency, and value of dermatology research.

Join us on Sept. 8! We are excited to share with you our research findings on the meaningfulness of nocturnal scratching to AD patients, and launch new resources for deploying scratch digital measures in clinical trials. Register now to attend this exciting launch event!

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  • 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

Founding Project Partners

Project Collaborators

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