Breakout Group Instructions: Day 2 July 28, 2021 Objective: Share insights on whats needed to demonstrate the meaningfulness of the endpoint. Small Group Discussions: Demonstrating Meaningfulness of the Endpoint Breakout sessions will be
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Presentation Transcript
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Breakout Group Instructions: Day 2 July 28, 2021<br>
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Objective: Share insights on what’s needed to demonstrate the meaningfulness of the endpoint. Small Group Discussions: Demonstrating Meaningfulness of the Endpoint<br>
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Breakout sessions will be 40 minutes long
Each participant will quickly introduce themselves (state name, role, and organization- <1 minute)
Facilitator will ask the discussion questions
Groups will use the case example to help guide answers
After 40 minutes, you will be prompted to reconvene to the plenary session for a recap (provided by each facilitator)
Accept the prompt back to plenary and then take a 5 min break before the recap Breakout Group Logistics<br>
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Atopic dermatitis (also known as atopic eczema) is a disorder characterized by inflammation of the skin (dermatitis)1
Onset typically occurs in infancy/childhood but can continue into adulthood
Clinical presentation: dry, itchy skin and red rashes that can occur on any part of the body, although the pattern tends to be different at different ages
Itch can be evaluated via subjective patient-reported assessments or by objective measurement of scratching activity. 2
Clinical trials now use scratching measurement as a primary outcome measure, and steps toward the standardization of itch assessment are being made to meet the growing need for reliably measuring itch and its impact on quality of life in the clinical research setting. 2 1. MedlinePlus. Atopic Dermatitis. https://medlineplus.gov/genetics/condition/atopic-dermatitis/
2. Erickson, S. Research Techniques Made Simple: Itch Measurement in Clinical Trial. Jrn of Inves Derm. Feb 2019 Atopic Dermatitis<br>
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Atopic Dermatitis “I want to be able to sit through my daughter’s recital without itching” scratching Outcome: minutes per day of total scratching
Endpoint: Change in the level of scratching as measured by mins/day Meaningful Aspect of Health (MAH) Concept of Interest (COI) Outcome to be measured Image Source: derived from playbook.dimesociety.org Case Example: Atopic Dermatitis<br>
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The specific novel endpoint for this example is:
Change in level of scratching
Measured in minutes/day of total scratching
Using an accelerometer*
In patients with moderate to severe atopic dermatitis Case Example * an instrument for measuring acceleration or for detecting and measuring vibrations<br>
