Clinical trials must prove that a new intervention or therapy has better outcomes than an alternative treatment. In order to generate statistically meaningful data, sponsors must decide on specific endpoints that, if met, provide confidence that one therapy is more advantageous over another. However, given the ever-changing landscape of oncology clinical trials, it can be difficult to determine which endpoints should be set for a certain trial type. Depending on the goals of the study and FDA regulations, it is vital to understand which endpoints will lead to the most impactful data.
This white paper will cover the following:
- An overview of clinical trial endpoints
- The FDA requirements regarding oncology endpoints
- How to determine endpoints for a study
