Collaboration between research groups is essential for sharing expertise and conducting clinical trials. These collaborations result in better delivery of therapeutic progress to cancer patients. The regulatory challenges of cross border cooperation can be a barrier to progress. Therefore, the regulatory procedures need to be addressed when clinical trials are conducted in different territories.
The Statement of Investigator Form FDA 1572 is an agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic. This form was not applicable to Europe and it was long recognised as an impediment to participation in non-IND trials (i.e., trials that do not involve investigational new drugs) for European clinical research groups, when joining US initiated clinical trials.
In 2019, signing the Form FDA 1572 was even deemed illegal and in certain European countries like Germany, EU GCP inspectors prohibited the completion of this form.
EORTC and US NCI addressed collegially the challenges. In January 2021, following discussions with EORTC, NCI have launched a new International Investigator Statement (IIS) in the Registration and Credential Repository (RCR) for European countries. This statement replaces the Form FDA 1572 for participation in US NCTN and NCORP trials that are not under IND. In order to participate in US trials that are under an FDA IND, the NCTN Group or NCORP group supporting the participation of European investigators must also obtain an official waiver from FDA that will exempt the investigator to signing the Form FDA 1572.
“We are grateful for NCI to adapt its CTEP platform requirements, enabling the registration of European clinical investigators without any legal complications from their own home countries,” said Dr Denis Lacombe, EORTC Director General. “We value our collaboration with NCI. In removing these types of barriers, both organisations focus on conducting research, much more efficiently, which will be beneficial to cancer patients.”