While many clinical trials are initiated by industry sponsors such as pharmaceutical companies or contract research organizations (CROs), other studies have their origins in a research location. If a researcher has an idea for a study they want to conduct, they can start what`s called an investigator-initiated study, or IIT. This article aims to provide a basic understanding of ITIs and their integration into the clinical research landscape. Similar to that of a researcher, the sponsor`s role in a TIS is the same as in an industry-sponsored study. The sponsor is the institution that initiates the clinical trial and acts as the coordinating body. They select qualified researchers from other sites that they believe are well suited to the study. Sponsors should ensure that the investigation is conducted in accordance with the general protocol and, where applicable, that the Investigational New Drug (IND) or Investigational Device Exemption (IDE) is managed. Proponents also provide information and training to investigators so that they can properly conduct their IR. As daunting as these responsibilities may seem, in most cases, an investigator is not the only person doing the research. they are based on a team of scientific staff. In this case, the auditor is responsible for each delegation of authority. In addition to a sponsoring researcher, the individual roles of researcher and promoter in an IR are always present. Since the examiner has two roles, the regulatory requirements for both roles are imposed on the examiner.
Externally sponsored collaborations are carried out in cooperation with an institution or organization (the external sponsor cannot be a pharmaceutical company or supplier. Individual investigators are not eligible to enter into a CES with Sanofi) based on jointly defined research where primary regulatory funding takes place outside of Sanofi. An IND is an application for FDA approval by an investigator to administer an investigational drug or biologic to humans. The FDA considers an investigational drug to be a substance that is not currently approved or approved for marketing by the FDA, but the study aims to expand its use to a new indication, route of administration, or dose that significantly changes the risk profile. Once an investigator has requested an IND, the clinical trial may not begin for an additional 30 days to ensure that the FDA has sufficient time to review the IND for the safety and well-being of research participants. The responsibilities of an investigator in an IR are the same as in any other clinical trial. Their primary responsibilities are to ensure that the clinical trial is conducted in accordance with applicable regulations, including the Institutional Review Board (IRB) and the Food & Drug Administration (FDA), protecting the rights, safety and well-being of subjects and controlling the use of the investigational drug. Investigator-sponsored studies are defined as unsolicited research from an external sponsoring unit, institution or organization, and include studies also known as investigator-sponsored trials (ISTs), expert-initiated research (RIA), or other terms that may refer to research sponsored or initiated by researchers. The funding agency and the products used in the clinical trial determine the regulations to be followed. For an FDA-regulated product, drugs (21 CFR 312) or devices (21 CFR 812) dictate the conduct of the study.
If another federal agency funds the research, HHS rules may apply (45 CFR 46). If a study is funded by an agency other than HHS but includes an FDA-regulated product, both sets of rules may apply. Because of the regulatory effort involved in the use of FDA-regulated products, many research sponsors are reluctant to conduct a clinical trial with regulated drugs or devices. The FDA offers detailed advice for those who are willing to try it. INDs and IDEs can be important for IITs. If a research promoter conducts research that requires an IND or IDE, they must also ensure compliance with the regulations applicable to these products. An IIT, also known as an investigator-initiated study (IIS) or investigator-initiated research (IIR), is a clinical trial in which the investigator designs the research, develops the protocol, and acts as the sponsoring investigator. The sponsoring investigator initiates and conducts a clinical trial – alone or with a team. It is under the direct direction of the sponsoring investigator that the investigational product (if any) is administered, distributed or used by a subject. As the name suggests, the obligations of a sponsoring investigator include those of a sponsor and an investigator: both the preparation and coordination of the study and its conduct. On the other hand, an IDE allows the use of an investigational product in a clinical trial to collect the safety and efficacy data necessary to support a marketing authorization application or pre-market filing with the FDA.
IDEs are essentially the same as INDs – they require FDA approval before use, with the only exception being that it is a verified device as opposed to a drug. PROPOSALS for the ISS/ESC to be carried out in the United States for the investigational drugs alirocumab, dupilumab and sarilumab should be submitted to Regeneron. To access the Regeneron ISS portal, click on this link: In addition, ITIs are particularly important for cancer centers. ITIs are required when an institution applies for and maintains the Cancer Centre Support Grant (CGSC). ITIs are essential when a cancer centre needs to demonstrate the six essential characteristics: focus on cancer, centre director, facilities, institutional commitment, organizational capacity, and transdisciplinary collaboration and coordination. You will need to register, upload your current curriculum vitae, license and global identification number (if applicable), identify an area of interest and describe your research plan. There are two types of unsolicited proposals: Investigator-Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC): To learn more about ITIs, including funding sources and challenges, read Advarra`s article “Meeting the Challenges of Investigator-Initiated Trials.” To access the Sanofi ISS/ESC Visiontracker registration/login page, click on this link: Among these features, ITIs demonstrate collaboration, institutional commitment and organizational capabilities. Traditional clinical trials typically operate within a department, while IITs involve frequent cross-functional collaboration. .