Held in Madrid on April 5, 2022, the conference “CTIS: full application of the Clinical Trial Regulation in Europe”, brought together a select group of experts in European clinical regulation (EU CTR 536/2014), who offered their vision of the new European portal from the perspective of the industry, the clinical research ethics committees and the transparency portal for patients.
In force since January 31, 2022, the Clinical Trial Information System, CTIS, gradually begins to be used by pharmaceutical companies, as explained by Carme Esteve in the conference. Esteve, responsible for the implementation of the EU CTR in the clinical study units at Sanofi and member of the EU CTR working group at Farmaindustria, published the results of a survey carried out among its associates on the CTIS and highlighted the excellent position of Spain within the framework of this new scenario for the management of clinical trials.
Tom Denorme, director of Clinical Operations and Regional Submission Lead Head at MSD, described MSD’s journey to CTIS, since 2014, when the European Clinical Trial Regulation was approved. Denorme showed that his company has opted to centralize the process in a team of regulatory experts (Central Clinical Trial Hub), who will act with the different stakeholders to advance in the complete management of their trials through CTIS.
Lidya Domínguez, director of Clinical Research at Sermes CRO and member of the EMA’s working group on CTIS since 2017, highlighted that one of the biggest challenges for the pharmaceutical industry now is the migration of clinical trials to CTIS. Therefore, the CROs services will be very useful in this new scenario, as they will cover the necessary resources during the transition period published by the EMA.
Emma Fernández de Uzquiano, Technical Secretary of the CEIm of the Hospital Universitario La Paz-Carlos III-HCB, delved into the need to continue working on mutual trust between the different evaluating entities (ethics committees and regulatory agencies of the European Union countries) of clinical trials in order to comply with the times established by the regulation.
María Teresa, Head of SCREN in the Research and Scientific Support Unit of the Research Institute of the Hospital 12 de Octubre, explained that the new transparency regulations empower the patient even more, by making public some information about clinical trials, that was confidential up to CTIS’s go-live.
All the speakers agreed that, although the implementation of CTIS opens a complex period for clinical trials in Europe, in the long term this new tool will allow promoters of treatments and medicines in Europe to work more effectively.
Antonio Berlanga, president of the Sermes Foundation for Clinical Research (organizing entity of the event) and CEO of Sermes CRO, took charge of opening the conference, which was moderated by Dolores Pérez, head of the Advanced Therapy Unit and the Clinical Documentation Unit. Josefina Berlanga, director of the Sermes Foundation for Clinical Research, closed the event.