In this free webinar, explore the nature and utility of scientific surveillance in the context of clinical trials. Attendees will review the specific aspects of scientific surveillance in dermatology clinical trials vs the broader context of studies in other indications. Learn how advanced statistical monitoring techniques can predict risks, identify inflated placebo responses and manage data quality risks that traditional monitoring methods may miss. The featured speakers will showcase 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.
TORONTO, Oct. 30, 2024 /PRNewswire-PRWeb/ -- 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 specialties. 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. The 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.
Join experts from PPD clinical research business of Thermo Fisher Scientific, (Moderator) Alessandro Maio, MSc, PhD, Project Oversight Sr. Director, Project Delivery - Cardiovascular and General Medicine (CVGM); Rakhi Kilaru, MS, MBA, Executive Director – Statistical Science; Amy R. Kroeplin, MPH, Sr. Director – Strategic Business Lead, Centralized Monitoring; and Michael Kuligowski, MD, PhD, MBA, Vice President – Medical Science and Strategy, Dermatology, for the live webinar on Wednesday, November 20, 2024, at 10am EST (3pm GMT).
For more information, or to register for this event, visit Managing Scientific Risks in Dermatology Trials.
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