Implementing rigorous assessments and securing the highest quality of data are major goals in dermatology clinical research. Traditional clinical trials can make it hard for patients to participate for reasons such as a busy work or personal life or the potential patient living far from a study site.
Decentralized clinical trials can open opportunities for wider inclusion and diversity within the dermatology patient populations, which is increasingly important as competition for patients for dermatology trials is fierce with many new drugs in development. By reducing barriers to clinical trial access including time commitment and location, decentralized trials can boost enrollment and increase retention and study compliance.
However, trial processes including multiple assessments that are key to capturing efficacy endpoints in these trials still require the same level of rigor as a centralized approach. With these assessments focused largely on raters and patients’ visual interpretation, how do we solve the challenge of these assessments when they are done remotely?
This webinar will identify key points to consider when designing and planning decentralized dermatology clinical trials, including:
• Strategies to result in favorable outcomes from a time, cost, and data quality perspective
• Study protocol considerations
• Recruitment metrics comparison: traditional clinical trials versus DCT
• Hybrid clinical trials versus complete DCT models
• Virtual options fit for purpose in dermatology trials
And we’ll discuss reporting technologies such as:
• Photography — at-home and on-site options
• Electronic diaries
• Wearable biomarker devices
• Telemedicine
Presented by
Stacy Weil,
Senior Vice President, Clinical Informatics
Stacy Weil is the Senior Vice President, Clinical Informatics at Premier Research. Stacy’s focus is on translating the organization strategy into actionable data initiatives that ultimately enable internal and external customers to achieve the highest level of performance and success. Prior to her role at Premier Research, Stacy worked in the role of Vice President of Clinical Data Operations at PatientiP and held prior roles in leadership in the Process Improvement, Data Analytics, Learning Services and Project Management groups at PPD.
Stacy’s operations experience includes project management and therapeutic leadership in the areas of Endocrine/Metabolic, Immunology, Urology, Women’s Health, Neuroscience, and Respiratory. Stacy’s trial oversight includes both global and domestic trials with teams in the US, Canada, Latin America, Asia Pacific and European Union.
Sonja VanWye, RN, MSN,
Executive Director, Program Delivery Dermatology
Sonja VanWye is an executive with over 19 years of dermatology experience providing strategic support for all dermatology programs through key stakeholder engagement and cross functional management. She works closely with teams ensuring operational excellence within the dermatology franchise. Sonja has worked in several positions during her 30-year tenure within the clinical trial environment such as dermatology strategist, senior director of dermatology project management/operations, quality assurance director, independent consultant, project manager, clinical research associate and safety officer.
Sonja VanWye has oversight and strategic experience with ~20 dermatology indications including some rare dermatology conditions and aesthetic trials conducted in over 30 countries across the globe.
Sonja obtained her Master of Science in Nursing graduating Magna Cum Laude and became a member of the Delta Epsilon Rho honour society. She has been a registered nurse for over 35 years. Her educational background along with her extensive history in dermatology provides her the experience to support her operational oversight position in an efficient and competent manner. She has been an author on several dermatology articles and has contributed to various presentations.
Jasmina Jankicevic, M.D.,
Vice President, Medical Affairs, Dermatology and Medical Aesthetics
Dr. Jasmina Jankicevic works with pharma, biotech, medical device, and cosmetic companies to drive clinical development, medical affairs and successful commercialization of innovative dermatologic and medical aesthetics solutions.
As a clinician, researcher, teacher and industry leader, Dr. Jankicevic has dedicated 20 years to innovation and optimization of therapeutic paradigms for more than 30 skin disorders including psoriasis, acne, rosacea, atopic dermatitis, skin and nail infections, wounds, hair loss, pigmentary disorders, autoimmune bullous dermatoses, genodermatoses, connective tissue diseases, photodamage, actinic keratosis and skin cancers.
She has successfully led clinical development programs and medical strategy in several companies including Premier Research, Allergan, Leo Pharma, and Murad.
Dr. Jankicevic is a trained dermatologist, and scientist, certified clinical research professional, trained journalist, published author and sought-after speaker. She holds Medical Degree, Master of Medical Sciences Degree and Board-Certification in Dermatology and Venereology from University of Belgrade, Serbia.
