Sponsors should limit placebo-controlled trials in cancer, FDA says

FDA released draft guidance Thursday to debunk the notion that FDA requires the use of placebo in randomized clinical trials for cancer therapies and clarify its general preference for active controls in such trials.

A spokesperson told BioCentury the agency recently heard concerns that people believe FDA requires placebo-controlled cancer trials. "While placebos are useful in reducing bias," the spokesperson said, "their use in trials in patients with malignancies, whether they be hematological or solid tumors (such as cancers and sarcomas), pose certain concerns" and "may not be suitable in many situations."...