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).
Investigator-initiated trial’s 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.
There are three main roles in an IIT; the sponsor investigator, the investigator, and the sponsor.
|IIT Sponsor Investigator Roles||IIT Sponsor Roles||IIT Investigator Roles|
|Conceives and creates the study||Selecting qualified investigators for the IIT||Ensure that the IIT is following the investigational plan|
|Coordinates the study||Ensure the protection of human subjects||Submit various documents including progress reports, safety reports, and financial disclosures|
|Conducts the study||Advise investigators on the proper protocols for the IIT||Obtain informed consent from subjects on the IIT|
|Is responsible for directing the investigation of drug/therapy that is administered during the trial||Monitor progress of the study||Control the therapies/drugs under investigation|
|Document the disposition of the IIT||Maintain case histories|
IITs are in many aspects the same as a normal clinical trial with the main difference being that the trial is being led by an investigator rather than a large pharmaceutical company. The trial
must follow the same steps as a normal clinical trial. Before and IIT can start, the investigator must complete an Investigational New Drug (IND) application through the FDA. In the application, researchers describe results from pre-clinical studies, details
about how the drug is made, who makes it, physical qualities of the drug, and outline what they hope will be clinical trial protocols. Applicants must also agree to get consent from all trial participants, have the study reviewed by an Institutional Review
Board (IRB) and follow many rules that come with studying a new drug in humans. In many cases IITs involve drugs that have already been FDA approved, therefore the process above may not be needed.
Once approved, IITs move forward as a phase 1 clinical trial. For a more in-depth explanation of the steps and process of clinical trials check out “Clinical Trials 101”. If the IIT makes it to phase IV of testing, the drug or therapy can be used in hundreds or thousands of patients on the trial. People enrolled in the trial will have access to the new treatment long before the general public.
IIT’s are incredibly important for developing new treatments and therapies for patients with cancer. They allow doctors and researchers to test treatments that their hands-on experience in the lab and clinic implies may offer meaningful results. At the CU Cancer Center, the CCTO is a group of more than 100 individuals, including certified research associates, a finance team, and a regulatory team. IITs highlight collaboration across an institution and the organizational ability of various departments to work together to conduct and carry out the trial. Additionally, IITs are generally faster to obtain proof-of-concept data or data that shows whether or not the trial is producing the expected results. This means that new drugs and therapies can be available to patients more quickly and potentially save more lives.
~ Chris Lieu, MD, Associate Director of Clinical Research