Investigator-Initiated Trials at the CU Cancer Center

If new and improved cancer therapies and treatments are the light at the end of the tunnel, clinical trials are the vehicles to get there. Clinical trials move research forward and help improve the quality of treatments available to patients. While many trials are initiated by sponsors, such as pharmaceutical companies, other clinical trials start in a research site, such as the University of Colorado Cancer Center. When a researcher has an idea for a study they would like to manage, they may start what is called an investigator-initiated trial (IIT) or investigator-initiated study (IIS).  

What is an Investigator-Initiated Trial?

Investigator-initiated trials are “homegrown” ideas from researchers and investigators who are active in lab and clinical settings. The sponsor investigator of the trial is not only sponsoring the study, but also conducting it. This means that they will be in charge of creating, coordinating, and carrying out the IIT. This may be done alone or with a team supporting the sponsor investigator.

Investigator-initiated trials are one of the many types of clinical trials offered at the CU Cancer Center. To see all clinical trials offered, follow the link below:

There are three main roles in an Investigator-initiated trial; the sponsor investigator, the investigator, and the sponsor. 

IIT Sponsor Investigator RolesIIT Sponsor RolesIIT Investigator Roles
Conceives and creates the studySelecting qualified investigators for the IITEnsure that the IIT is following the investigational plan
Coordinates the studyEnsure the protection of human subjectsSubmit various documents including progress reports, safety reports, and financial disclosures
Conducts the studyAdvise investigators on the proper protocols for the IITObtain informed consent from subjects on the IIT
Is responsible for directing the investigation of drug/therapy that is administered during the trialMonitor progress of the studyControl the therapies/drugs under investigation
 Document the disposition of the IITMaintain case histories

Investigator-Initiated clinical trials (IITs) represent the clinical application of the most innovative and cutting-edge cancer research performed here in Colorado to improve the treatment and prevention of cancer in our state.

Chris Lieu, MD, Associate Director of Clinical Research


This is how Coloradans get access to potentially life-saving therapy years before it becomes standardized.

Richard Schulick, MD, Director of CU Cancer Center

Latest Clinical Trials from the CU Cancer Center

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