Workshop B – Overcoming Hurdles in Ophthalmic Clinical Trial Design to Spearhead Development
Time: 1:00 pm
day: Pre-Conference Workshop Day
Details:
This session will be delving into how clinical trial design can be optimized for ophthalmic delivery, leveraging experienced clinical trialist’s knowledge on robust design to accelerate development.
Key Topics to be Discussed:
- Reducing Screen Failures: Strategies for designing effective trials that minimize patient screen failures
- FDA Guidelines for INDs: Understanding and implementing the necessary FDA guidelines for successful Investigational New Drug (IND) submissions
- Achieving Targeted Endpoints: Best practices for defining and meeting trial endpoints
- Patient Enrolment Challenges: Approaches to overcoming challenges in patient recruitment and retention
- Navigating Stratification: Techniques for effectively stratifying patients within trials to enhance data reliability
- Operational Synergies: Creating synergies in trial operations to streamline processes and improve efficiency