FDA says sponsors should limit placebo controlled trials in cancer


23 August 2018 - FDA released draft guidance on Thursday to debunk the notion that FDA requires the use of placebo in randomised clinical trials for cancer therapies and clarify its general preference for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."

For tumour types that have available standard of care treatments, maintaining a blind for patients receiving placebo in a trial whose disease progresses may delay treatment with approved drugs or other investigational therapies, the agency wrote in the guidance.

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Michael Wonder

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Michael Wonder