Exploring the Challenges of Designing and Executing First-in-Human Oncology Trials

This webinar will highlight key considerations and best practices for designing and executing FIH oncology trials, offering practical solutions to help sponsors navigate the regulatory, operational, and clinical hurdles inherent to these studies.

📅 Thursday, April 24, 2025 | 10am EST (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)

FIH oncology trials require careful preparation and strategic implementation, from study design and investigational new drug (IND) submission to site startup, patient recruitment, and cohort management. To ensure success, sponsors must navigate a host of challenges to ensure safety, timeliness, and scientific validity.

Agenda:

• Preparing a robust IND package
• Developing a clear plan for dose escalation
• Streamlining site initiation and patient recruitment
• Managing cohorts and safety review committees
• Q & A

Register for this webinar to explore best practices such as regulatory preparation, site initiation, cohort management and safety monitoring for designing and executing first-in-human oncology trials.

Join us to learn the best practices for designing and executing FIH oncology trials,  navigate the regulatory, operational, and clinical hurdles inherent to these studies.