Transition to the new EU CTIS Portal for Regulatory Clinical Trial Submissions: VHIO’s Start-Up Unit Analysis

Background: The Start-up Unit at Vall Hebron Institute of Oncology (VHIO) Clinical Trials Office was created to meet the needs a growing number proposals, aiming homogenize tasks for all (CT). On 31st January 2022, new European Portal under EU Regulation 536/2014 CT submissions (Clinical Information System, CTIS) became available. During applicants may choose either Country specific portal or CTIS submissions. In 2023, must use CTIS. 2025 ongoing have transitioned objective this work is review Regulatory Authorities (RA) VHIO’s proposals performed in 2022 through and gather potential challenges innovative process. Materials/Methods: RA been analyzed by Start-Up Unit, including received 2021 2022. Platform used submission, de Ensayos Clínicos con Medicamentos from Agencia Española del Medicamento (AEMPS) CTIS, has determined each CT. All further assessed collecting feedback staff charge Specifically, training received, difficulty impact internal processes considered. Results: A total 100 submission requests were 1st 15th June 2022: 64 36 confirmed 70% CT, only 11% being portal. According Phase, 50% phase I represented an out other II/III 12% Regarding quarterly distribution submissions, 0 Q1 vs. 8 Q2. Monthly was: 5 April, 1 May 2 Considering type sponsor: 75% Biotechs (BC) 12.5% Pharmaceutical Companies (PC) Academia (AC). Active requesting revealed intention additional Four (2 sponsored BC PC) Phase (sponsored PC).100% surveyed teams agreed user-friendly platform, however reported their working manner. Only company-related use, but stated EMA provided appropriate trainings manuals accessible users. Conclusion: Out 70 initiated during mostly BC. An increasing trend as year progresses observed. Overall according collected, initiative feels promising facilitating process Countries. No conflict interest.