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CLINICAL TRIALS OFFICE

CLINICAL TRIALS OFFICE

Launched 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, sample managers, administrative as well as quality control staff, who coordinate phase I–IV clinical studies and also participate in several translational research projects at VHIO.

Organized into three groups, covering all tumor types and studies, our personnel are managed by the Clinical Trials
Office Director, Marta Beltran.

In 2019 we managed 1 phase 0, 139 Phase I, 23 Basket studies, 141 phase II, and 121 phase III clinical trials with active recruitment throughout the year (see Figure), with patient enrolment totaling at 1122. 150 new trials were initiated, including 8 post-authorization trials and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2019 and are still enrolled and receiving study treatment (more than 900 patients in total, and more than 1400 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 leading reference in early clinical studies.

As a reflection of our continued expansion as well as recognition of excellence, we have undergone 16 audits with positive results and VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – Fundación ”la Caixa”, directed by Elena Garralda, has been reaccredited by the Generalitat de Catalunya.

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’.

The prestige of our Hospital’s Medical Oncology Department is increasingly recognized by pharmaceutical as well as
biotechnology companies. It has also become a reference program and selected by the industry to carry out complex
clinical trials for which the number of participating centers is highly restricted.

Clinical sites are selected based on the highest standards of quality 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. We have also conducted more than 10 Investigator-Initiated
Trials (IITs).

For more information about Phase I, Basket studies, and early Phase II trials, please see  the Research Unit for Molecular Therapy of Cancer UITM – ”la Caixa”.


STRATEGIC GOALS

  • Contribute to the development of novel therapies against cancer.
  • Consolidation as an international reference for clinical trials in oncology.
  • Guide patients enrolled in trials to comply with the protocol requirements and help them with daily life throughout the duration of their participation.
  • Ensure that the protocol is appropriately conducted from initiation to the close of the respective clinical study.
  • Standardize clinical trial processes to ensure optimal quality and the compliance of Good Clinical Practice (GCP).

CURRENT OBJECTIVES

  • Contribute to the development of novel therapies against cancer.
  • Consolidation as an international reference for clinical trials in oncology.
  • Guide patients enrolled in trials to comply with the protocol requirements and help them with daily life throughout the duration of their participation.
  • Ensure that the protocol is appropriately conducted from initiation to the close of the respective clinical study.
  • Standardize clinical trial processes to ensure optimal quality and the compliance of Good Clinical Practice (GCP).

TEAM


Director

  • Marta Beltran

Head, Clinical Trials Office for Phase I Trials

  • Silivia Pérez

Study Coordinators

  • Eulalia Aliende
  • Ariadna Arasanz
  • Eva Belen Banus
  • Lluïsa Carbonell
  • Guillem Cunill
  • Raquel de La Torre
  • Nuria Farras
  • Maria Garcia
  • Maria Herranz
  • Andreu Martínez
  • Sonia Martinez
  • Anna Matres
  • Laura Maynés
  • Montserrat Moreno
  • Gemma Mur
  • Laura Oliva
  • Adelaida Piera
  • Mirieia Sanchis
  • Mireia Sole

Data Managers

  • Ariadna Arasanz
  • Ignacio Carcela
  • Marina Coll
  • Gloria Garcia
  • Jordina Llavall
  • Anna Martinez
  • Lidia Martinez De Arenzana
  • Carles Montoliu
  • Alejandro Pardines
  • Sergi Pérez
  • Xavier Pérez
  • Montserrat Pujadas
  • Rosa Maria Romero

Head, Clinical Trials Office for Phase II-III Clinical Trials (GI, Lung, Head & Neck, and Gyne)

  • Mara Beltran

Study Coordinators

  • Izar Achaerandio
  • Núria Bascuñana
  • Elena Fernandez
  • Laura Garcia
  • Raquel Garcia
  • Irene Garrido
  • Raquel Gutierrez
  • Cristina Pérez
  • Iratxe Puebla
  • Sergi Recasens
  • Laura Sanchez
  • Lorena Trejo
  • Angeles Valls
  • Román Vidal

Data Managers

  • Berta Feliu
  • Laura Garcia
  • Iris de la Fuente
  • Laia Gregori
  • Raquel Gutierrez
  • Eva Mª Lázaro
  • Eva Marín
  • Silvia Marín
  • Asal Rinaldi
  • Julia Serra
  • Eduard Solà

Head, Breast, GU, CNS, Sarcoma, Gynecological Clinical Trials

  • Meritxell Soler

Study Coordinators

  • Enric Álvarez
  • Nuria Collantes
  • Carlos Fernandez
  • Sergio Fernandez
  • Pol Gonzalez
  • Sara Gutierrez Fernandez
  • Montserrat Hernandez
  • Alba Meire
  • Thaïs Miquel
  • Olga Padrós
  • Mariona Pocarull
  • Angela Maria Quintana
  • Ester Serra

Data Managers

  • Cristina Aguilar
  • David Alvarez
  • Raquel Madrenas
  • Maria Isabel Martinez
  • Maria del Mar Suares
  • Carina Monclús 
  • Nuria Ortega

Head, Clinical Trials Hemtatology Group

Study Coordinators

  • Queralt Ferrer
  • Clara Lopez
  • Ana Mafalda Nunes
  • Judit Pinteño
  • Elena Sanchez
  • Julia Sedo
  • Laura Segura
  • Andrea Tricas

Data Managers

  • Josu Iraola
  • Alejandro Lahire
  • Magda Masana
  • Soraya Peralta
  • Aida Rebollo