Clinical trials in dermatology are not substantially different from those in any other area of medicine, although they have certain distinguishing features vs other medical specialities. These include development of drugs for topical use (in addition to systemic ones) where the vehicle effect (a combination of placebo and emollient/therapeutic effect) can raise the placebo rates to levels higher than in other specialties.
Consistent and reliable quality of clinical data in dermatology trials relies heavily on a quality-by-design mindset, focus on factors critical to quality and the use of advanced statistical monitoring methods (as an integrated holistic approach) to manage data quality risks. Scientific inconsistencies (or incompatibility) refer to noteworthy departures in efficacy and safety assessments from clinical expectations.
The implementation of advanced statistical monitoring techniques, collectively referred to as scientific surveillance, is essential for identifying data quality risks within centralized monitoring frameworks as traditional monitoring methods may prove insufficient.
Scientific surveillance aims to achieve three primary objectives: 1) detecting inconsistencies in scientific data, 2) predicting risks and 3) identifying inflated placebo responses. However, its ability to assess site-level anomalies is limited by the requirement for a minimum sample size.
In this webinar, the speakers will explore the utility of scientific surveillance, which integrates statistical, scientific and clinical insights to safeguard data integrity in clinical trials. They will examine its role in the early detection and subsequent prevention of data aberrations. This webinar will also highlight the importance of applying scientific scrutiny to clinical trials in dermatology through scientific surveillance, as well as its broader applicability across all areas of clinical research.
Register for this webinar to discover how scientific surveillance is transforming data integrity in dermatology trials.
Speakers
(Moderator) Dr. Alessandro Maio, MSc, PhD, Project Oversight Sr. Director, Project Delivery - Cardiovascular and General Medicine (CVGM), PPD clinical research business of Thermo Fisher Scientific
Dr. Maio is a motivated, customer-focused Sr Director with more than 20 years of clinical research experience. Since 2021, he has been a part of Dermatology Pillar lead team at PPD Clinical Research Services-Thermo Fisher Scientific.
After completing his PhD in Molecular Microbiology, he has covered all roles of clinical trials right from Clinical Research Associate, Clinical Team Manager to Project Manager for studies, thus obtaining a 360° know-how for all aspects of clinical trials.
Dr. Maio has in-depth knowledge of clinical trials for most dermatology indications (psoriasis, HS, alopecia, atopic dermatitis) as well as pediatric and rare dermatology diseases (blistering diseases: PV&PF, bullous pemphigoid).
Message Presenter
Rakhi Kilaru, MS, MBA, Executive Director - Statistical Science, PPD clinical research business of Thermo Fisher Scientific
Ms. Kilaru brings over 20 years of clinical trial experience and has led several phase II-III trials in dermatology, cardiovascular outcomes, neuroscience and inflammatory disorders. She provides input into study design, analyses and leads enterprise-level initiatives. Her research interests and contributions include centralized statistical monitoring tools and scientific surveillance methods.
Ms. Kilaru was at Duke Medicine for 11 years prior to joining CRG and has co-authored and analyzed data to support several manuscripts published in peer-reviewed journals. She plays an active role in the ASA Biopharmaceutical section and is the Past Chair and Member of several scientific and leadership committees.
Message Presenter
Amy R. Kroeplin, MPH, Sr. Director – Strategic Business Lead, Centralized Monitoring, PPD clinical research business of Thermo Fisher Scientific
Ms. Kroeplin is a Senior Director, Centralized Monitoring, with over twenty years of experience in the clinical research industry in various roles, including monitoring and project management. She holds a Master’s of Public Health Degree in Epidemiology and Biostatistics. As a Senior Director, Ms. Kroeplin provides strategic direction and management of the centralized monitoring function as part of the leadership team delivering centralized statistical monitoring and risk surveillance for clinical studies.
Ms. Kroeplin is a member of the RBQM working group governance supporting risk-based quality management process oversight and strategy, including standard operating procedure development for risk management, quality tolerance limits, centralized monitoring and reduced source document review/verification.
Message Presenter
Dr. Michael Kuligowski, MD, PhD, MBA, Vice President - Medical Science and Strategy, Dermatology, PPD clinical research business of Thermo Fisher Scientific
Dr. Kuligowski, MD, is based in the USA and brings over 35 years of healthcare experience with more than 25 years of regional and global clinical trial (Phase I-IV) and medical affairs experience in the pharmaceutical industry. He has 12 years of clinical experience as a Dermatologist, primarily at academic hospitals and is a board-certified Dermatologist with a MD in Dermatology (ultrastructural research of the skin).
Dr. Kuligowski is a Project Leader who has led the development of numerous dermatology drugs and aesthetic products at several pharmaceutical companies ranging from startup, midsized and the largest ones. He has also led several successful regulatory submissions in dermatology; the latest of which (atopic dermatitis) ended in the drug’s approval on Sept 21, 2021 (USA).
Message PresenterWho Should Attend?
This webinar will appeal to:
- Biotech and biopharma sponsors interested in dermatology assets
- Companies involved with scientific surveillance
- Healthcare providers and clinicians
- Clinical Research Investigators and Site Directors
What You Will Learn
Attendees will gain insights into:
- The nature and utility of scientific surveillance in the context of clinical trials
- The specific aspects of scientific surveillance in dermatology clinical trials vs the broader context of studies in other indications
- Advanced statistical monitoring techniques that can predict risks, identify inflated placebo responses and manage data quality risks that traditional monitoring methods may miss
- The unique challenges of dermatology trials, particularly related to placebo effects in topical treatments and how to safeguard the consistency and reliability of clinical data
Xtalks Partner
PPD
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, their capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, they serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, they apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.
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