Description: The structure of an investigator-initiated trial (ITT) program can take many forms depending on the policies of the researcher’s institution and the involvement of the company whose investigational product is being studied. For some IITs, the researcher’s institution may act as the sponsor, while for others the researcher acts as the sponsor, and in some IITs (but not all) the researcher and company work closely together to develop the IIT protocol and throughout the conduct of the IIT. This session aims to discuss varying IIT program structures and the potential challenges and other considerations to consider in designing an IIT program that can best meet the desired research goals.