FDA Guidance: Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics

Two years ago, I had a post discussing "Dose Cohort Expansion Study - A Never Ending Phase I Study Design". Last month, FDA officially issued the guidance for industry "Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics".

With this guidance, we expect that more sponsors will adopt this study design in oncology trials and beyond the oncology trials.

The dose cohort expansion study design completely changed the traditional phased approaches for clinical trials for drug development. The phases I, II, III, IV are no longer critical.