US FDA's Complex Trial Design Pilot Might Be Handicapped By Disclosure Requirements
FDA wants to publicize some aspects of designs accepted into pilot, which might discourage industry participation.
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Agency officials can now discuss the ideas that have been accepted, though not in great detail.
Program allows eight months for sponsors to be accepted and conduct two meetings with FDA on an innovative design, but the agency said more time may be needed.
US FDA says sponsors generally won’t need to publicly disclose company or product if selected for pilot, but rather elements about design of their complex trial.