When Catalyst Oncology implements the European Union Clinical Trial Regulation (EU CTR) across Sponsor studies the Site Activation Management (SAM) team is often asked what impact certain elements will have on the submission process. We frequently find ourselves responding with “it depends.” There is no one-size-fits-all approach to clinical research, and the EU CTR is no exception. As clinical trials become more complex and regulations evolve, Sponsors’ goals remain the same: a need for dynamic solutions requiring flexibility and creativity tailor–made to their specific scenarios.
Below are three case studies illustrating several challenges SAM team has mitigated, the opportunities the team has explored with our Sponsors based on their strategies and our approaches with EU CTR and the Clinical Trials Information System (CTIS) process. In these examples, we supported Sponsors throughout the process to ensure efficient regulatory approval timelines.
Close collaboration for overcoming hurdles
Sponsors must understand that making changes to the protocol or other clinical trial documents after CTIS submission can create challenges. More important than the changes themselves, how the changes are responded to affects the activation timelines either positively or negatively; therefore, responses and experience are important in understanding the impact of critical decisions that need to be tailored to each project.
Case Study 1. During the part I assessment, the Sponsor received several queries related to the investigational medicinal product dossier (IMPD), investigator’s brochure (IB), and protocol resulting in a protocol amendment, and in other requested changes to the documents. Our SAM team instructed the Sponsor on the steps to take to understand the impact of the document changes, including the deadlines to hit the required response timeline and the effects on their strategy. Three days after the timeline was set, the Sponsor released a protocol amendment, updated IB, IMPD, and synopsis to our team. Some of the protocol amendment updates impacted the main informed consent form (ICF) and the country ICFs in Spain, France, and their translations. At this time, the part II assessment for Spain was concluded and closed with an approved country ICF version for Spain linked to the original protocol version submitted in part I.
Following consultation with the Sponsor, the SAM team contacted the Spanish ethics committee and requested re-opening the part II assessment to raise an additional query for the part II assessment in the system for the country ICF for Spain. This allowed Catalyst Oncology to make changes within the CTIS system part II and resubmit a revised country ICF for Spain linked with the new revised protocol version as a result of the queries received in part I assessment review.
This complex strategy and thinking outside of the box enabled Catalyst Oncology to provide a new main ICF version and country ICF updates (Spain and France) with completed translations within 24 hours along with a submission to the committee’s RFI in part II. All other queries in the protocol, IB, and IMPD were addressed in parallel and on time with the new documents during the RFIs in part I.
As illustrated, it is vital to address queries and receive documents within the provided due dates to manage any hurdles. Otherwise, delays or amended documents can impact and derail timings. When such events occur, diligence, flexibility, creative thinking, and attention to the EU CTR guidance helps to mitigate challenges.