VHIO's Transversal Clinical Trials Core Services & Units

Please click on the corresponding groups below

Clinical Trials Office

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Director
› Gemma Sala

Heads, Phase I Clinical Trials
› Gemma Sala
› Elisabet Sicart

Study Coordinators
› Eulalia Aliende
› Ainhoa Balague
› Marta Beltran
› Raquel Blanco
› Lluïsa Carbonell
› Raquel de La Torre
› María García
› María Herranz
› Sonia Martínez
› Lidia Martínez De Arenzana
› Sandra Matas
› Laura Maynes
› Montserrat Moreno
› Gemma Mur
› Silvia Pérez
› Adelaida Piera
› Veronica Ripoll
› Josep Bernat Roman
› Sofia Rubio
› Elisabet Sicart
› Mireia Sole

Data Managers
› Miguel Ángel Caelles
› Laia Cano
› Gloria García
› Anna González
› Paola Ley
› Anna Martínez
› Montserrat Pujadas
› Silvia Puyalto
› Isabel Rico
› Rosa María Romero

Head, GI, Lung, Head & Neck Phase II-III Clinical Trials
› Marta Beltran
› Isabel Grau

Study Coordinators
› Alejandra Caballero
› Iris de la Fuente
› Maria Mercè García
› Patricia García
› Irene Garrido
› Cristina González
› Débora Moreno
› Iratxe Puebla
› Sergi Recasens
› Andrea Retter
› Eulalia Scheenard
› Sandra Tijeras
› Ingrid Vilimelis

Data Managers
› Anna Aguilar
› Laia Gregori
› Eva Mª Lázaro
› Eva Marín
› Silvia Marín
› Cristina Pérez
› Sergio Pérez
› Julia Serra

Head, Breast, GU, CNS, Sarcoma, Gynecological Clinical Trials
› Susana Muñoz
› Meritxell Soler

Study Coordinators
› Judith Alonso
› Enric Álvarez
› Marta Batista
› Beatriz Bruno
› María Alba Calamardo
› Violeta Esteban
› Carlos Fernández
› Sergio Fernández
› Berta Garrido
› Jordi Humbert
› Gina Mares
› Alba Meire
› Thaïs Miquel
› Olga Padros
› Mariona Pocarull
› Ángela María Quintana
› Ester Serra
› Anna Serrano

Data Managers
› David Álvarez
› Marta Batista
› Maria Isabel Martínez
› Carina Monclus
› Nuria Ortega

Head, Clinical Research Support Unit
› Susana Muñoz

Sample Managers
› Gemma Pruna
› Cristina Resina

Clinical Trials Office Administrative Support
› Núria Carballo
› Cristina García
› Alexandre Gonzalo
› Marc Palomar
› Pau Ruiz-Olalla

Quality Assurance Manager
› Silvia García

SUMMARY

Established in 1997, our Clinical Trials Office incorporates an expert team that conducts clinical trials at the Vall d’Hebron University Hospital’s (HUVH) Oncology Department. More specifically, our 45 professionals including study coordinators, data managers, administrative staff and quality control, coordinate studies from Phase I to Phase IV as well as various research projects. Divided into three to cover all tumor types and trials, our teams are managed by the Clinical Trials Office Director, Gemma Sala.

In 2016 we conducted 354 actively recruiting trials - Phase I, Basket studies, Phases II & III (see Figure II) with patient enrolment totaling at 1129 (Figure I). 136 new trials were initiated (Figure III). In addition, we continue to follow up patients who were recruited prior to 2016 and are still enrolled and receiving study treatment (more than 1600 patients in total).

As we continue to render personalized medicine more precise by better targeting 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 must also 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 immunotherapeutics, matched to each individual’s molecular ‘measurements’.

The Vall d’Hebron University Hospital’s Oncology Department has gained much prestige which has been acknowledged by the pharmaceutical companies. It has consequently become a reference center selected by the industry to carry out complex clinical trials for which the number of participating centers is highly restricted. Selected site are chosen based on their high standards of quality and capacity for carrying out state-of-the-art research. Our hospital has taken part in phase I trials of different drugs, ultimately enabling the pharmaceutical industry to market novel anti-cancer medicines. We consequently participate in clinical trials promoted by the pharmaceutical industry as well as those developed by our department in collaboration with other hospitals.

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Figure I: Annual Recruitment Evolution (Phase I + Basket Trials, Phase II and III)


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Figure II: Annual Distribution of Phase I, Phase II, Phase III, Basket, and Post Authorization Trials


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Figure III: Distribution of New Trials Initiated in 2016


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).

HIGHLIGHTS

  • Internal restructuring with the newly created position and appointment of the Director of the Clinical Trials Office, Gemma Sala.
  • In 2016 we set up our Clinical Research Support Unit to help our investigators with the start-up and management of independent research lines.
  • We continue to report an increase in both the number of clinical trials performed and the number of patients included.
  • Optimal management of the complexity of protocols which are increasingly demanding.
  • We have provided tailored training for our staff in order to further improve the quality of work and expand related skill sets.
  • Implemented new tools and procedures aimed at increasing the quality and efficacy of research.
  • 20 sponsor audits have been conducted with satisfactory results.
  • Inspection for Accreditation of the phase I Unit, the Research Unit for Molecular Therapy of Cancer (UITM) – ”la Caixa”, by the Generalitat de Catalunya.

HORIZONS 2017

  • Over the last few years the Clinical Trials Office has not only improved quantitatively but also qualitatively. Our main objective for the future is to continue expanding our portfolio of clinical studies, maintain the high quality offered in-house as well as to our patients, and thus become a reference at global level for novel cancer therapies and precision medicine in oncology.
  • We plan to both consolidate and expand our newly created Clinical Research Support Unit.
  • We aim to update and create new SOPs to ensure the standardization and quality of all procedures performed in clinical trials.
  • Create new tools and systems to standardize and facilitate procedures for our clinical trials.
  • Focus on managing Investigator Initiated Trials (IITs).
  • Continue with our GCP course.
  • Organize the 12th edition of oncology clinical trials post-graduate course.
  • Optimal data completion and exploitation using our recently implemented software for clinical trial management.
  • Continue to follow the established procedures for the accreditation of the Research Unit for Molecular Therapy of Cancer (UITM) – “la Caixa”, and extend and apply these to our other teams. We also aim to further improve sample management through the appointment of sample coordinators.