Designing an Effective Clinical Trial

The discussion will provide best practices and tips on getting the most out of communications with the FDA. Other topic areas include:

• Making the most of feasibility studies
• The critical importance of pilot studies
• Common pitfalls in the design and conduct of pivotal trials
• Development and negotiation of non-inferiority margins in a non-inferiority trial
• Some important aspects of investigational site selection
• Communicating with FDA during the pre-submission and submission process