Developing, writing, operationalizing, and conducting clinical trials is incredibly complex. To aid in investigator continuing education about some of these complex processes, the UNCLCN and UNC Lineberger Sponsored Clinical Research Services have put together 19 self-paced, online courses for investigators. They cover a variety of topics including the creation of a clinical trial, responsibilities associated with sponsoring a clinical trial, and business principles surrounding project management of activating clinical trials. CME credits are available on most courses. The target audience for the course is investigators within the cancer center, physicians, and clinical research staff.
Kaitlin Morrison, PhD, the Director of UNC Lineberger Sponsored Clinical Research and Assistant Professor of Medicine, Division of Hematology, joins us for a brief interview on the topic of the new Investigator-Initiated Trials courses.
Please explain what an investigator initiated trial (IIT) is and how it differs from any other clinical trial.
An investigator-initiated trial (IIT) is a trial developed by the investigator as opposed to an external pharmaceutical company. The investigator “sponsors” the trial and gets to decide what the trial looks like. Often IITs are done in collaboration with pharmaceutical partners who provide investigational drugs and overarching guidance; however, some trials are completely developed using UNC manufactured products. Overall, on an IIT, the investigator drives the science, gets to explore new ideas, and gets to get creative. They create a trial tailored to our patients at UNC, driving science forward in a direction based upon their innovative ideas of ways to address unmet needs in cancer.
Why is there a need for IITs?
IITs are developed to expand the boundaries of cancer treatment, and they allow investigators who actually see the patients to drive the science forward. They are based on science, ideas, and UNC’s patient population as opposed to just a marketing plan to eventually make money off an investigational drug.
What kind of results are anticipated from these courses?
This course series is to help new and seasoned investigators learn more about IITs and their responsibilities if they hold an investigational new drug (IND) application or sponsor one of these trials. The point of the course is to pull back the veil and help investigators see the resources that Lineberger Comprehensive Cancer Center has to help develop and run these studies.
What are some of the biggest challenges with an IIT, and how can these courses help?
When you are an investigator on a clinical trial that is externally sponsored by a pharmaceutical company, you only have to worry about treating your patient in clinic per the protocol and local regulatory approvals through the IRB. IITs mean that you take on all the responsibilities of being a sponsor, including monitoring the study, developing the forms to capture the data, overseeing all the sites across the world that run their studies based on your protocol, developing your protocol, and gaining FDA approval for your protocol. There are so many more responsibilities involved with them that are way more complex and require a higher level of subject matter expertise.
What got you interested in this complex process as a researcher?
In regulatory affairs, we always talk about how there are two types of individuals who work on a project: 1. The astronomer who finds the new bright star in the sky (or the new target to direct a drug to help treat cancer), and 2. The engineer that helps get you to the moon and back so you can keep moving the science to get to that star. I like being the engineer to push the new ideas to patients and help better the treatment options. IITs often target individuals who have no other treatment options. Working with IITs helps drive science so that these individuals either have a treatment option (in the form of a clinical trial) OR help us understand the science better to develop new treatment options for future patients.
Will there be more topics and courses explored in the future?
Right now, this course series is focused on treatment trials in which an investigational drug/device is used to treat the patient’s cancer. In the future, we intend to extend the course to include content on nontreatment trials such as health registries and biospecimen studies.
Is there any other relevant information you would like to share?
This course series was developed based on highly attended and popular in-person lectures given to investigators about INDs, IITs, and sponsor responsibilities over the last couple of years. The lectures received overwhelmingly positive feedback, and investigators asked to have them at their fingertips. Furthermore, we hope to use this course to help onboard new investigators when they come to UNC.