FDA rolls out guidance for seamless cancer trials

FDA released draft guidance Friday outlining how companies can use seamless trial designs to consolidate the traditional three-phase approach into one first-in-human study to expedite development of cancer drugs and biologics.

Seamless trials use a single protocol that runs continuously and is amended to expand cohorts and/or add new ones until there is enough evidence to approve a candidate, or scrap its development. BioCentury's 2016 Back to School issue recommended that drug sponsors plan seamless studies to rapidly confirm early signals of exceptional responses and evaluate dosing regimens and candidate biomarkers without the need to set up new studies (see "Haste, not Waste")...