Beyond the Surface: Navigating Endpoint Complexity & Safety in Dermatology Clinical Trials

In dermatology clinical trials, seeing change and proving clinically meaningful change are not the same thing. Disease can fluctuate between visits, severity can vary across body regions and patients and clinician assessments and patient-reported symptoms may capture different components of the treatment story.
Without adequate controls, this variability can make meaningful treatment effects harder to detect and interpret. Building confidence in the evidence requires an endpoint strategy that accounts for each step in the assessment workflow that may introduce variability or bias. This webinar explores how an integrated endpoint strategy can help control these sources of variability and strengthen confidence in dermatology trial evidence.
Bringing these measures together can provide a more complete picture of efficacy, patient experience and safety. Standardized image capture and centralized imaging workflows can reduce variability in longitudinal visual assessments and provide a method to appropriately document flares or safety events without imparting significant burden to site personnel or patients. Consistent clinician-reported outcome (ClinRO) implementation and robust rater training can strengthen scoring reliability, while well-designed electronic clinical outcome assessment (eCOA) strategies can capture the day-to-day patient experience beyond site visits.
This webinar brings together experts in medical imaging, eCOA and cardiac safety to explore how these complementary approaches can strengthen endpoint quality in dermatology trials. The speakers will discuss strategies for improving image consistency, reducing inter- and intra-rater variability, capturing meaningful symptom data and addressing factors that may contribute to placebo response. They will also examine what cardiac safety assessments may be required and how ECG strategies can be incorporated efficiently.
Register to learn how dermatology clinical trials can benefit from a more integrated endpoint strategy that reduces variability, strengthens confidence in treatment-effect data and generates a more complete body of evidence across efficacy, patient experience and safety.

Who Should Attend
This webinar will benefit professionals in the following fields or job titles:
CEOs/Chief Medical Officers/Chief Scientific Officers
Clinical Data Managers/Clinical IT/Clinical Monitoring
Clinical Operations/Clinical Development (early phase)
Clinical Research/Clinical Pharmacologists/Clinical Scientists
Data Science
Digital Health/Innovations/Operations
Health Economics and Outcomes Research
Imaging Scientists/Medical Affairs/Medical Monitor/Head of Development for Program
Neuroscience Clinical Trials Professionals
PK Experts/Protocol Managers/Regulatory Affairs
Professionals in the field of Dermatology
Sr. Managers, Trial Initiation

What You Will Learn
Attendees will learn how to:
Standardise image capture to improve endpoint consistency
Learn how high-quality, standardised photo capture and centralised imaging workflows can reduce variability and support more reliable visual assessment across sites and patients
Use imaging to track flares and treatment-related change over time
Explore how longitudinal imaging can help document disease flares, monitor reductions in visible signs and provide objective evidence to complement traditional clinician assessments
Strengthen ClinRO quality through rater training and standardisation
Understand how effective rater training, consistent ClinRO implementation and self-injurious behavior can reduce inter- and intra-rater variability and improve confidence in endpoint data
Capture the day-to-day patient experience of dermatologic disease
Learn how well-designed eCOA / PRO strategies can support accurate symptom reporting, participant engagement and consistent data capture while helping sponsors address factors that may contribute to placebo response
Efficiently address cardiac safety requirements indermatologic product development
Understand relevant approaches to cardiac safety assessment in dermatology development programs and how effective ECG and related safety data strategies can help sponsors identify and manage risk efficiently
Build a more integrated evidence strategy for dermatology trials
See how combining eCOA, imaging and cardiac safety data can give sponsors a more holistic view of treatment efficacy, patient experience and safety while supporting efficient trial execution

Register free on Xtalks:
https://xtalks.com/webinars/beyond-the-surface-navigating-endpoint-complexity-safety-in-dermatology-clinical-trials/