FDA Sees Challenge In Distinguishing Lung Cancer Symptoms From Drug Side Effects

08 Jul 2013

At the third patient-focused drug development meeting under PDUFA V, FDA staff urged patients to try to differentiate between symptoms caused by the underlying disease and those resulting from treatment, an important distinction when it comes to assessing the efficacy and safety of new drugs.

FDA’s patient-focused drug development public meeting on lung cancer showed the challenges of developing new outcome measures and clinical trial endpoints when the line between the disease’s symptom burden and the treatment’s side effects is blurred.

During the course of the half-day meeting June 28, it became clear that with lung cancer it can be difficult...