Innovation and Role of Alternative Markers of Efficacy - Episode 5

Segment 5 - Surrogate End Points in Clinical Trials: The Right Information?

For approval of therapies in oncology, clinical trials aim to demonstrate improved overall survival of a treatment compared with a comparator or control arm. However, looking for improvement in overall survival can take an extended period of time, and in some cases may be unethical due to study design. Therefore, with the hope of getting an effective drug approved and on the market sooner, researchers are using surrogate end points, including progression-free survival, time-to-treatment failure, and time to progression.

Richard W. Joseph, MD, describes how progression-free survival can be a useful end point and can also help to assess quality of life, an important measure for patients. Ira M. Klein, MD, MBA, FACP, brings up the question, “What are we paying for? Cure? Long-term remission? Quality of life?”

Watch our related Peer Exchange, Oncology Stakeholder Summit 2014: Evidence-Based Decisions to Improve Quality and Regulate Costs