Investigator initiated trial

An Investigator Initiated Trial, also known as an Investigator Initiated Study or IIT for short,1 is a study initiated by scientists, universities or study centres without commercial interest. IITs aim to optimize applied therapies and to establish the best therapy between several treatment arms. Investigator Initiated Trials can therefore have a high significance for the study participants. The overall responsibility and project management is usually assumed by the initiating clinic or the head of the clinical trial, whereas the manufacturers of drugs or medical devices do not act as the main responsible parties and do not determine the contents of the study.

Investigator Initiated Trials are financed either by third-party funds, by public institutions such as the Federal Ministry of Education and Research (BMBF) or the German Research Foundation (DFG), foundations or industry. In IITs, the investigator, the clinic or the study centre is the sponsor, as the initiator of the study is responsible for the financing and can therefore, for example, also raise funds from several sources.

IITs are subject to the same regulatory requirements as commercial clinical trials and are conducted strictly in accordance with Good Clinical Practice (GCP), the German Drug Law (AMG) and the German Medical Devices Act (MPG). Therefore, study protocols and final reports have to be written, monitoring has to be carried out and solid FDA-compliant databases with audit trails have to be created as well as in commercial studies. As in commercial studies, the study participants or test persons may have to be insured, which must be clarified by the sponsor (i.e. the initiating clinic or the head of the clinical trial).

All studies must be approved by the ethics commissions and the higher federal authorities (BOB) before they can begin, so that ethical issues are also checked in all Investigator Initiated Trials. Due to the strict regulations, contract research institutes are often called in to perform at least partial tasks such as monitoring.