Beginner's Guide To Investigator-Initiated Trials

By Meghan Hosely, Marketing Content Writer

While many clinical trials are initiated by industry sponsors, such as pharmaceutical companies or contract research organizations (CROs), other trials originate within a research site. When an investigator has an idea for a study they’d like to conduct, they may begin what is known as an investigator-initiated trial, or IIT. This article aims to provide a basic understanding of IITs and how they fit into the clinical research landscape.

What is an IIT?

Also referred to as an investigator-initiated study (IIS) or investigator-initiated research (IIR), an IIT is a clinical trial in which the investigator conceives the research, develops the protocol, and serves as sponsor investigator. The sponsor investigator initiates and conducts a clinical trial – alone or with a team. It’s under the sponsor investigator’s immediate direction that the investigational product (if any) is administrated, dispensed to or used by a subject. As the name implies, the obligations of a sponsor investigator include both those of a sponsor and those of an investigator: both creating and coordinating the study and conducting it.

Who is involved in an IIT?

In addition to a sponsor investigator, the individual roles of investigator and sponsor are still present in an IIT. Since the investigator is assuming dual roles, the regulatory requirements for both roles are imposed upon him or her.