More about the webinar
Clinical trials are primarily involved in establishing the safety and efficacy of candidate therapeutics to a high degree to allow for regulatory approval and usage in real-world patients.
However, regulators still have significant interest in ensuring the safety of therapeutics post-approval. Therefore, post marketing surveillance studies are a vital tool to verify the efficacy, safety and potential additional benefits of therapeutics in clinical practice - with a particular interest in finding and investigating any rare side effects.
However, the design of post-marketing surveillance studies is highly variable with many having inadequate design or are underpowered for their objective(s) of interest. Better consideration of design and appropriate sample size determination could lead to more improved Phase IV trial performance.
Join us as we cover the purpose of Phase IV trials, common design considerations for post-marketing surveillance trials and sample size determination for testing for rare side-effect-related outcomes.
