All Times EDT
Keywords: Oncology, Single arm trials, real world data
Treating cancer patients with a combination of therapeutic products can be advantageous to the patient because of a synergy among different mechanisms of action. Oncology occupies a constantly changing competitive landscape and it can sometimes be difficult or unethical to recruit patients into randomized clinical trials of combination therapies because of a perceived or actual absence of equipoise. Single arm trials have been used in monotherapies to successfully demonstrate product activity against a cancer. The need to for all components of a therapy to be effective makes interpreting single arm trials for combination therapies challenging. Drug developers have proposed to use external controls to address confounded treatment effects. This presentation will discuss FDA experience reviewing single arm trials of combination therapies for oncology trials, including proposals to use real world data as an external or historical control.