While many clinical trials are initiated by industry sponsors, such as pharmaceutical companies or clinical 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 you with a basic understanding of IITs and how they fit into the clinical research industry.
What is an IIT?
Also referred to as an investigator-initiated study (IIS), 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 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.
Similar to an investigator, the sponsor’s role is the same on an IIT as it would be on an industry-sponsored trial. The sponsor is the entity initiating the clinical trial and acting as the coordinating center. They select qualified investigators at other sites they believe are a good fit for the trial. Sponsors ensure investigation is conducted following the general investigational plan laid on in the protocol, and managing the investigational new drug (IND) or investigational device exemption (IDE) if applicable. Sponsors also provide information and training to investigators to properly conduct their IIT.
The responsibilities of an investigator on an IIT are the same as any other clinical trial. Their main duties are ensuring the clinical trial is conducted according to the applicable regulations, including the Institutional Review Board (IRB) and Food & Drug Administration (FDA), protecting the rights, safety and welfare of subjects, and controlling the use of the investigational product. This includes following the protocol, training staff properly, maintaining adequate and accurate records, review and report adverse events (AEs) and serious adverse events (SAEs), obtaining consent from subjects, and administering drugs only to the subjects under investigator supervision.
However, an investigator isn’t the only person conducting research; they rely on a team of research staff. As with all clinical trials, the investigator is responsible for any and all delegation of authority.
Why are IITs important?
IITs drive translational research by taking information from clinical trials to address critical medical needs. Translational research takes basic science research and applies it to day-to-day, real-world practices. Oftentimes, it is described as taking a protocol from “bench to bedside.”
Additionally, IITs are especially important for cancer centers. IITs are required when an institution applies for and maintains the Cancer Center Support Grant (CCSG). IITs are key when a cancer center needs to demonstrate the six essential characteristics: cancer focus, center director, facilities, institutional commitment, organizational capacity and trans-disciplinary collaboration and coordination.
Of these characteristics, IITs demonstrate collaboration, institutional commitment and organizational capabilities. Traditional clinical trials typically work within one department, while IITs involve frequent cross-functional collaboration. Working with different departments in your institution is one way to show your organization’s capabilities in conducting and carrying out an IIT. IITs also show that your organization is financially capable. IITs are relatively expensive to run, so it’s important to show how you are using different funding or grants your institution has received. By keeping these things in mind, it will help your institution when it comes time to apply for or maintain your CCSG.
What are INDs and IDEs?
An IND is a request from an institution for an authorization from the FDA to administer an investigational drug or biologic to humans. The FDA considers an investigational drug to be any substance for which approval is sought. After an institution applies for an IND, the clinical trial cannot start for another 30 days, ensuring the FDA has ample time to review the IND for the safety and wellbeing of research participants.
On the other hand, an IDE allows an investigational device to be used in a clinical study to collect safety and effectiveness data required to support premarket approval application or a premarket notification submission to the FDA. IDEs are essentially the same as INDs – they require approval from the FDA prior to use, the only exception is it’s a device being reviewed as opposed to a drug.
Both INDs and IDEs can be important to IITs. If a sponsor-investigator is conducting research that requires an IND or IDE, they must ensure a higher degree of compliance.
To learn more about IITs, including funding sources and challenges, read Advarra’s article “The Noble Pursuit of Investigator-Initiated Research.”