Beyond Phase I: Expansion Cohort Trials Bring Efficiencies, Regulatory Challenges

First-in-human, expansion cohort trials are on the rise in oncology, but protocols for such studies can be highly problematic, lacking clear objectives, well-defined populations and independent oversight.

Sponsors seeking to conduct Phase I expansion cohort studies must be prepared to address numerous design, statistical and ethical hurdles inherent in such an approach so that the data can be used to support product registration, a multi-stakeholder group said at a cancer research policy conference Nov. 17.

Traditional clinical trial phases in oncology development are increasingly becoming blurred, leading to more first-in-human trials that are subsequently expanded...

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