IISs are clinical studies initiated and managed by a nonpharmaceutical company researcher/s who could be an individual investigator, an institution or a group of institutions, and a collaborative study group or a cooperative group. IISs are also known by several other names that include Investigator-Initiated Trials, Investigator-Sponsored Trials, Noncommercial Trials, Academic Clinical Trials, Physician-Led Studies and Investigator-Driven Clinical Trials, Academic. The term investigator can also be substituted by the term “Academic” or “Physician” and the term “Clinical trial” can be replaced by “Study.”The fundamental premise here is that the responsibility of being both the sponsor and investigator lies with the person who conceives of and conducts the study.
