Clinical trials unit (CTU)
The Clinical Trials Unit (CTU) is an IDIBAPS platform that forms part of the Clinical Research Support Unit of the Clinical Pharmacology Service of the Hospital Clínic de Barcelona.
It was created in 1998, and is made up of a multidisciplinary group of professionals. Its objective is to support, promote, and enhance the clinical research carried out within and from the institution. Research is promoted through an integrated structure of services that guarantees the highest ethical, scientific, and quality standards, in order to conduct studies efficiently and competitively, ensuring compliance with current regulations, the safety and well-being of participants, and the quality of the data.
The activity of the CTU begins with an initial advisory phase regarding the methodological, ethical, and regulatory aspects of the projects. Subsequently, it develops the clinical trial’s design, coordination, monitoring, pharmacovigilance, preparation of reports and communication of results. Support is offered to research staff in each of the stages of execution of their research projects.
The active participation of the CTU in clinical trials promoted by the institution has been key to fostering investigator-initiated research, promoting academic clinical research within the Hospital Clínic itself. In addition, the CTU's extensive experience in phase I-IV clinical trials and other types of projects, both national and international, allows it to provide cross-departmental support in different therapeutic areas, adapting to the specific needs of each type of project. Along these lines, and continuing at the forefront of medicine, the CTU has been key in the development of phase I and II clinical trials with advanced therapy medicinal products (ATMP) of its own development (in-house), as well as in vaccines aimed at infectious diseases and to fight COVID-19.
The CTU collaborates with the Spanish Clinical Research Network (SCReN) – an ISCIII platform since 2014 – and the European Clinical Research Infrastructure Network (ECRIN), a European consortium of research infrastructures funded by the European Commission.