Established in 1997, our Clinical Trials Office is directed by Marta Beltran and incorporates experts conducting clinical trials at the Vall d’Hebron University Hospital’s (HUVH) Medical Oncology Department, headed by VHIO’s Director Josep Tabernero.
This Office comprises study coordinators, data managers and administrators who coordinate phase I–IV clinical studies and also participate in several translational research projects at VHIO. Our team is organized into 4 groups; start-up unit, oncology study coordinators, oncology data entries, hematology study coordinators and data entries, covering all tumor types and studies.
In oncology and hematology, in 2022 we managed a total of 3 phase 0 trials, 262 phase I trials, 33 basket studies, 186 phase II trials, 209 phase III clinical trials, and 1 medical device study, with active recruitment throughout the year, and patient enrollment in our oncology and hematology clinical trials totaled at 1,503. In addtion, we managed 2 phase III studies and 1 post-authorization trial in radiotherapy including a total of 10 patients.
230 new trials were initiated in 2022, including 14 post-authorization trials, and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2022 and are still enrolled and receiving study treatment (1,180 patients in total, and 2,087 in follow-up).
Cristina Pérez
Head of the CTO
In 2022 we managed 3 phase 0, 210 phase I, 29 basket, 159 phase II, and 140 phase III clinical trials, and 1 medical device study with active recruitment throughout the year (Figure I), with patient enrollment totaling at 1,328 (Figure II). 181 new trials were initiated, including 12 post-authorization trials, and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2022 and are still enrolled and receiving study treatment (1,170 patients in total, and 2,002 in follow-up).
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 a leading reference in early clinical studies. Reflective of our recognized 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 the specificities of each individual patient, each individual tumor, the requirements and selection criteria for inclusion in certain studies are becoming more complex.
We are dedicated to expanding our portfolio of trials in to ultimately establish new treatment models with highly selective drugs. Our Unit continues to fine-tune patient selection criteria to identify those patients who are most likely to benefit from novel therapies, including emerging immune-based treatments, tailored to individual patients’ molecular ‘measurements’.
In 2022 we managed 52 phase I, 4 baskets, 27 phase II and 69 phase III clinical studies with active recruitment throughout the year (Figure III), with patient enrollment totaling at 175 (Figure IV). 49 new trials were initiated, including 2 post-authorization trials, and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2022 and are still enrolled and receiving study treatment (229 patients in total, and 150 in follow-up).
Clinical research is hematology is spearhead by Francesc Bosch, Principal Investigator of VHIO’s Experimental Hematology Group.
The prestige of HUVH’s Medical Oncology Department is recognized by pharmaceutical and biotechnology companies. It has also become a reference program and selected by the industry to carry out complex clinical trials. The number of participating centers in these studies is highly restricted.
Clinical sites are selected based on the highest quality standards and capacity for carrying out state-of-the-art research. We have participated in early phase trials of different drugs, ultimately enabling the pharmaceutical industry to market novel anti-cancer medicines. We are involved in studies promoted by the pharmaceutical industry as well as those developed by us in collaboration with other hospitals. In 2022, we also conducted more than 17 investigator-Initiated trials (IITs) in oncology.
- Contribute to the development of novel therapies against cancer.
- Consolidation as an international reference for clinical trials in oncology and hematology.
- Guide patients enrolled in clinical trials to comply with the protocol requirements and help them with daily life throughout the duration of their participation.
- Standardize clinical trial processes to ensure optimal quality and the compliance of Good Clinical Practice (GCP).
- 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
Cristina Pérez
Head of data entry
Ignacio Carcela
Head of Hematology
Laura Segura
Lead Study Coordinators
Eulalia Aliende, Montse Moreno, Olga Padrós, Gemma Mur, Enric Álvarez, Eva Banús, Júlia Sedó, Queralt Ferrer
Lead Data entry
Gloria García, Eva Lázaro, Joana Pinyol, Alberto Rojo
Study Coordinators
Aitana Almodóvar, Enric Alvarez, Eva Banus, Marina Barbero, Anna Cabrera, Júlia Caparrós, Laia Catalán, Paula Chiquillo, Nuria Clotet, Constancio Collado, Natàlia Écija, Núria Farras, Carlos Fernández, Danis Fernánez, Queralt Ferrer, Anna Giralt, Laia Gispert, Sara Gutiérrez, Montse Hernandez, Josu Iraola, Alejandro Lahire, María López, Raquel Madrenas, Alba Martínez, Elena Martinez, Sònia Martínez, Magda Masana, Ana Matres, Thais Miquel, Mireia Mira, Alejandro Pardines, Jordi Perera, Marta Rotxes, Álvaro Rueda, Elena Sánchez, Laura Sancho, Laura Saucedo, Júlia Sedó, Samira Sehir, Jana Simón, Maria Del Mar Suanes, Albert Texidor, Christian Rosales, Alba Galiana
Data Entry
Cristina Aguilar, Sara Álvaro, Nestor Babon, Samanta Bascuas, Carlota Bellot, Laia Benitez, Elisabet Beseran, Helena Carbonero, Clara Escala, Neus Iserte, Joan Izquierdo, Bàrbara Juanmiquel, Eva Marín, Sílvia Marín, Carla Martinez, Raquel Masip, Miriam Meseguer, Carina Monclús, Paula Nuñez, Adriana Oños, Victor Ortega, Ana Pedraza, Sergio Perez, Xavier Perez, Joana Pinyol, Eva Puerma, Olga Reyes, Isabel Rico, Alberto Rojo, Jordi Romero, Rosa Romero, Blanca Ruiz de la Torre, Judith Serrano, Inés Tejero, Júlia Toledo, Marta Vidigal, Cristina Calderón, Íñigo Arauco, Martina Serrat, Andrea Fores, María Padial
Clinical Trials Assistants
Gisela Andrés, Cristian Campderros, Nuria Carballo, Marc Palomar
