Scientific and Operational Execution of Tobacco Harm Reduction Studies
Clinical and behavioral studies are cornerstones of any Premarket Tobacco Product Application (PMTA) submission, from pharmacokinetic to actual use investigations. This webinar will explore the scientific and operational fundamentals of tobacco harm reduction (THR), including the human biological effects of alternative products compared to combustible cigarette use and how market insights and real-world evidence contribute to a better understanding of the potential reduction in risk from switching. We will discuss several different design types, with multiple objectives and endpoints such as pharmacokinetics, abuse liability assessment, biomarkers of exposure and potential harm, as well as behavioral studies such as Tobacco Product Perception and Intention (TPPI) and actual use. This webinar will present key considerations for successful planning of THR activities, including items such as:
- Importance of collaboration, targeted recruitment strategies and alignment with regulatory expectations
- Key considerations in CRO selection for conducting successful tobacco harm reduction studies
- Strategies in integrating biological and behavioral data
- Insights into navigating regulatory requirements in the U.S. and the rest of the world
- The role of behavioral studies in informing regulatory research for new tobacco products
Join DVCR experts for this webinar to gain valuable insights into Tobacco Harm Reduction studies.
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