We, as Coordinating Center, and all of our member sites, understand the importance of FDA compliance. Before trial activation, the sponsor or investigator is required to give a determination of the applicability of filing an IND application for the study, according to the FDA’s current guidance on IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer.
Consortium studies, particularly investigator-initiated trials, may be IND-exempt. Those that do not meet exemption criteria will have INDs held by trial sponsors that could range from industrial firms to the lead site or lead investigator of a Consortium study. To date, most sponsors have been from industry or CTEP; however, going forward, an industry sponsor, lead site, or lead investigator will have the option to transfer study oversight responsibilities to the Consortium via the CCTC. The Coordinating Center will ensure that proper processes are in place for compliance with FDA requirements. To this end, Consortium leadership has collaborated with the FDA’s Center for Devices and Radiological Health (CDRH) in the development and analytical validation of predictive biomarkers in prostate cancer.