Investigator-initiated trials (IITs) at Hollings
The mission of MUSC Hollings Cancer Center is to reduce the burden of cancer in South Carolina and beyond. To do this, it is critical to conduct clinical trials that seek to answer questions relevant to patients in this state. Clinicians and basic scientists are encouraged to develop clinical trials based on their work and observations.
What is an investigator-initiated trial?
An investigator-initiated trial (IIT) is a clinical trial that is conceived, developed and led by an investigator. It may be a single site or multisite trial. IITs represent locally-generated ideas driven by clinical needs or scientific inquiry.
Terms to know
The U.S. Food and Drug Administration (FDA) provides the following definitions:
- Sponsor: A person who takes responsibility for and initiates a clinical investigation. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.
- Sponsor-Investigator: An individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. This individual takes on the dual role of a sponsor and an investigator.
- Investigator: An individual who conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. “Sub-investigator” includes any other individual member of that team.
Sponsor Investigator Support Unit (SISU)
The Sponsor Investigator Support Unit (SISU) at Hollings acts as the Sponsor and offers comprehensive support from concept development through trial close-out, including:
- Collaborates with HART on the writing of protocols;
- Prepares and files regulatory submissions to the FDA, Institutional Review Board (IRB), Protocol Review Committee (PRC), Data and Safety Monitoring Committee (DSMC) and others;
- Coordinates across MUSC units, such as the Investigational Drug Pharmacy or the Office of Research & Sponsored Programs;
- Conducts eligibility reviews, ongoing data monitoring, and maintenance of the regulatory study binder; and
- Partners with the Biostatistics Shared Resource on RedCap database development and statistical analysis.
Please note: SISU does not provide proposal or grant writing services. Instead, the unit encourages early concept submission to HART so that SISU can be engaged to assist with budget estimates.
