This episode focuses on best practices for proactive communication with regulatory agencies, such as the FDA and ICH, during early-phase clinical trials. We discuss the importance of early and open communication in building a strong relationship with regulators and gaining clarity on their expectations. The episode provides practical tips for researchers on how to effectively communicate with agencies, emphasizing the need for clear, concise, and data-driven submissions. We explore strategies for addressing regulatory queries and adapting trial protocols based on feedback, highlighting the importance of flexibility and collaboration. The episode also touches upon the legal framework governing drug development in the US, particularly 21 CFR Part 312, which outlines the requirements for investigational new drug (IND) applications.

Furthermore, the episode delves into the role of the International Council for Harmonisation (ICH) in establishing global standards for drug development. We discuss the importance of staying up-to-date with evolving regulations and guidelines and understanding different regulatory perspectives from around the world. The episode also explores the complexities of CMC (chemistry, manufacturing, and controls) information in IND applications and the importance of providing thorough and accurate data. Finally, the episode concludes by emphasizing the importance of quality over quantity in communications with regulators, and how a well-structured submission can facilitate a smoother and more efficient review process.