Our Clinical Trials Office (the CTO) was established in 1997. The CTO is formed by a team of professionals who lead clinical trials (CTs) conducted at the Service of Medical Oncology and the Service of Hematology of Hospital Universitari Vall d’Hebron, which are involved in more than 600 CTs. Our team is made up of study coordinators, data entries and clinical trial assistants. Our tasks include logistics, coordination, and data management and the launch of novel CTs.
The CTO is composed of four units:
- Start-up and Partnership Unit: led by Sílvia Pérez Pujol, who is the contact person for novel CT projects (phase I to IV CTs). Pérez Pujol and the principal investigator of the CT evaluate the scientific interest and logistics of the CTs. Pérez Pujol is also responsible for building new partnerships with Sponsors and CROs, and performs regular follow-up of partnership activities and operation.
- Coordination Unit: led by Marta Beltran, who is responsible for arranging the procedures required by the study protocol, and is the liaison between the Sponsor and the research team. This Unit is composed of six groups, each one led by a senior coordinator.
- Data Management Unit: led by Ignacio Carcela, who is responsible for data quality and provides all the necessary data to the Sponsor. This Unit is organized into three groups, each one led by a senior data manager.
- Hematology Unit: led by Laura Segura, who manages novel CT proposals related to the field of hematology and supervises the coordinators and data managers of these CTs.
The CTO provides support for phase I, II, III and IV CTs conducted either by the industry or by research groups, including research studies proposed by researchers at our center.
In 2020, the CTO managed 474 open CTs in the field of oncology, and coordinated the inclusion of 1,084 patients in phase I to III CTs, and the inclusion of 156 patients in phase IV studies. In 2020, the CTO coordinated the prescreening of more than 600 patients and performed the follow-up of 1,700 patients. In the area of hematology, our Office managed 120 open CTs and coordinated the inclusion of 153 patients in phase I to III CTs, and of 38 patients in post-authorization studies. Our Office also coordinated the screening of 230 patients and the follow-up of 85 patients.
Figure I: Annual distribution of oncology clinical trials (Phase 0, I + Basket, II and III) and post authorization trials with active recruitment
Figure II: Annual recruitment of patients enrolled in oncology clinical trials (Phase 0, I + Baskets – II–III) and post authorization trials
More than half of our patients included in our Phase I Clinical Trials have been referred to us from other Hospitals, which has consequently positioned our Unit as leading reference in early clinical studies. As a reflection of our continued expansion as well as recognition of excellence, VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch directed by Elena Garralda, has been re-accredited by the Generalitat de Catalunya – Government of Catalonia. As we continue to render personalized medicine more precise by matching therapies to respond to the specificities of each individual patient, each individual tumor, the requirements and selection criteria for inclusion in certain studies are also becoming more complex. While we are dedicated to expanding our portfolio of trials in order to ultimately establish new treatment models with highly selective drugs, we continue to fine-tune patient selection criteria in order to best identify those patients who are most likely to benefit from novel therapies, including emerging immune-based therapies, tailored to individual patients’ molecular ‘measurements’.
In 2020 we managed 39 Phase I, 36 phase II, and 45 phase III clinical trials with active recruitment throughout the year (Figure III) with patient enrolment totaling at 153 patients (Figure IV). 50 new trials were initiated, including 7 post-authorization trials, and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2020 and are still enrolled and receiving study treatment (more than 122 patients in total, and more than 74 in follow-up). Clinical research is spearhead by Francesc Bosch, Group Leader of VHIO’s Experimental Hematology Group.
Figure III: Annual distribution of hematology clinical trials (Phase I + Basket, II and III) and post authorization trials with active recruitment
Figure IV: Annual recruitment of patients enrolled in hematology clinical trials (Phase I + Baskets – II–III) and post authorization trials
- To contribute to the development of novel treatments for cancer.
- To help participants comply with the requirements of the protocol and provide them daily life assistance throughout the study.
- To provide data that meets the highest quality standards and complies with data entry deadlines.
- To facilitate the work of and communication between the different professionals involved in the CT (oncologists, nurses, pharmacists, pathologists, to name a few).
- To ensure compliance with the protocol from the start to the end of the study.
- To incorporate novel tools and procedures to improve the quality of the CTs conducted in our center.
- To reduce data entry time and implement a remote monitoring system.
- To establish standard operating procedures for the launch of novel CTs.
- To collaborate with Sponsors and CROs for the implementation of platforms that facilitate the launch of CTs and storage and updating of the associated documentation.
- To provide individualized training to our personnel to improve their performance and professional skills and competences.
Clinical Trials Office Director
Head Of start-up unit and Clinical Trials Liaison
Head of data entry
Head of Hematology
Lead Study Coordinators
Olga Padrós, Cristina Perez, Ester Serra, Eulalia Aliende, Montse Moreno, Guillem Cunill
Lead Data entry
David Alvarez, Gloria García, Eva Lázaro
Carlos Fernández , Maria Del Mar Suanes, Montse Hernández, Maribel Martinez, Nuria Clotet, Enric Álvarez, Alba Martinez, Thaïs Miquel, Alba Meire, Julia Haro, Maribel Martinez, Júlia Serra, Jordi Perera, Ana Giralt,Irati Fernandez, Alvaro Rueda, Raquel Madrenas, Alba Martinez, Sònia Martínez, Anna Cabrera, Gemma Mur, Marina Barbero, María López, Ana Matres, Aitana Almodovar, Alejandro Pardines, Albert Teixidó, Laura Saucedo, Eva Banús, Núria Farràs, Elena Martinez, Joel Puig; Mafalda Nunes, Júlia Sedó, Queralt Ferrer, Josu Iraola, Danis Fernàndez, Magda Masana, Cristian Rosales, Alejandro Lahire, Marta Rotxés, Laura Sancho.
Álvaro Aunós, Gloria Garcia, Lidia Martinez De Arenzana, Andrea Gomez, Sergio Perez, Joan Izquierdo, Alba Novella, Mariona Guillamet, Rosa Romero, Jordi Romero, Clara Escala, Blanca Ferriz, Gerard Orriols, Ines Tejero, Isabel Rico, Marta Vidigal, Miriam Meseguer, Raquel Masip, Eva Mª Lazaro, Silvia Marin, Eduard Sola, Neus Iserte, Eva Marin, Eva Puerma, Xavier Perez, Samanta Bascuas, Asal Rinaldi, Joana Pinyol, Nuria Ortega, Emma Bigas, Carlota Bellot, Carina Monclús, Pilar Jimenez, David Alvarez, Olga Reyes, Cristina Aguilar, Helena Carbonero, Helena Montanuy, Jordina Llavall, Natàlia Écija, Alberto Rojo, Mireia Mira, Nestor Babon, Sara Álvaro, Laia Ortiz, Adriana Oñós, Rebeca Sánchez
Clinical Trials Assistants
Nuria Carballo, Marc Palomar, Gisela Andrés, Cristian Campderro