Keys to a successful pivotal trial design in oncology

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.