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.
Speakers
Olga Bokeriya, MD, PhD, Senior Cardiologist and ECG Core Director, Clario
Dr. Olga Bokeriya is a board-certified Cardiologist and Cardiovascular Researcher with extensive experience in clinical cardiology, electrophysiology and cardiovascular surgery. Throughout her career, she has contributed to numerous scientific publications, served in academic leadership roles and focused on advancing the understanding and treatment of cardiovascular disease.
As Senior Cardiologist and ECG Core Director, Dr. Bockeria oversees ECG scientific strategy, cardiac safety assessments and clinical trial support across a range of therapeutic areas. She works closely with sponsors and investigators to ensure high-quality cardiac data collection and analysis in global clinical research programs.
Message Presenter
Amit Vasanji, PhD, Vice President, Medical & Scientific Affairs, Clario
Dr. Amit Vasanji has over 20 years of experience in basic and clinical research image acquisition, processing, analysis, visualization and biomedical software engineering across multiple modalities and therapeutic areas. His research has been published in a broad array of peer reviewed journals and he is frequently invited to speak at international events on effective workflow design and algorithm based biomarker development for imaging based clinical trials. In his current role at Clario, Amit oversees the General Medicine and Special Solutions group within Clario’s Medical Imaging services.
Message Presenter
Prateek Verma, MD, Director, eCOA Science & Consulting, Clario
Dr. Prateek Verma is an MD with more than 25 years’ experience in clinical research. He has served as Clinical Investigator in global neuro-psychiatry clinical trials. Dr. Verma has worked extensively in areas of AD, schizophrenia, MDD, bipolar disorder, dementia, other behavioral disorders, infectious diseases and dermatology.
Dr. Verma also held an advisory position for NIHR research design services and primary mental health clinical trials unit (PRIMENT), whilst working for Medical Research Council, UK and University College London. He presently oversees eCOA design, investigator training and outcome analysis activities in global psychiatric, neurology and non-CNS indications and serves as an expert presenter at global investigator meetings and mentors’ scientific staff.
Message PresenterWho 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 standardization
- Understand how effective rater training, consistent ClinRO administration utilizing standardized eCOAs help 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
Xtalks Partner
Clario
Clario, part of Thermo Fisher Scientific, is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. We offer comprehensive evidence-generation solutions that combine medical imaging, eCOA, precision motion, cardiac and respiratory endpoints.
For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have been deployed over 30,000 times to support clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2012.
For more information, go to Clario.com or follow us on LinkedIn.
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