Established in 1997, our Clinical Trials Office incorporates experts conducting clinical trials at the Vall d’Hebron University Hospital’s (HUVH) Medical Oncology Department, the Vall d’Hebron Barcelona Hospital Campus. Headed by VHIO’s Director, Josep Tabernero, our team comprises study coordinators, data managers and administrators who coordinate phase I–IV clinical studies and also participate in several translational research projects at VHIO.
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, this team is managed by our Clinical Trials Office Director, Marta Beltran.
In 2021 we managed 4 phase 0, 180 phase I, 27 basket, 153 phase II, and 147 phase III clinical studies with active recruitment throughout the year (Figure I), with patient enrolment totaling at 1,326 (Figure II). 183 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 2021 and are still enrolled and receiving study treatment (890 patients in total, and 2016 in follow-up).
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 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 in order 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 2021 we managed 49 phase I, 2 basket, 35 phase II, and 60 phase III clinical trials with active recruitment throughout the year (Figure III) with patient enrolment totaling at 182 patients (Figure IV). 67 new trials were initiated, including 6 post-authorization trials, and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2021 and are still enrolled and receiving study treatment (140 patients in total, and 105 in follow-up).
Clinical research is hematology is spearhead by Francesc Bosch, Principal Investigator 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
- 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
Head Of start-up unit and Clinical Trials Liaison
Head of data entry
Head of Hematology
Lead Study Coordinators
Eulalia Aliende, Guillem Cunill, Montse Moreno, Gemma Mur, Olga Padrós, Cristina Perez, Júlia Sedó, Ester Serra
Lead Data entry
David Alvarez, Gloria García, Eva Lázaro, Alberto Rojo
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, Cristian Rosales, Marta Rotxes, Álvaro Rueda, Elena Sánchez, Laura Sancho, Laura Saucedo, Júlia Sedó, Samira Sehir, Jana Simón, Maria Del Mar Suanes, Albert Texidor
Cristina Aguilar, Sara Álvaro, Nestor Babon, Samanta Bascuas, Carlota Bellot, Laia Benitez, Elisabet Beseran, Helena Carbonero, Clara Escala, Adrià Jaime Fernández, 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
Clinical Trials Assistants
Gisela Andrés, Cristian Campderros, Nuria Carballo, Marc Palomar