There are a multitude of questions to consider when designing a pivotal trial in oncology in order for your product to succeed. This presentation will give an overview of the essential questions you need to answer focusing on:
- How large should the trial be based on clinical precedents, data on your own compound including its uncertainty and whether the effect is immediate?
- What should be the primary endpoint(s)?
- Options to hedge your bets when there is >1 endpoint, experimental arm or population
- What comparator to use
- Special considerations for single arm trials
- An outline of alternative designs and additional questions to consider.