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
Elisabet Sicart
Silvia Pérez

Study Coordinators
Sonia Abad
Eulalia Aliende
Ainhoa Balague
Raquel Blanco
Lluïsa Carbonell
Raquel de La Torre
Maria Garcia
Maria Herranz
Iris Martinez
Sonia Martinez
Laura Maynés
Montserrat Moreno
Gemma Mur
Laura Oliva
Adelaida Piera
Mireia Sole

Data Managers
Ariadna Arasanz
Ignacio Carcela
Marina Coll
Giovanni De Marino
Gloria Garcia
Jordina Llavall
Anna Martinez
Lidia Martinez De Arenzana
Marta Monserrat
Sergi Pérez
Isabel Rico
Montserrat Pujadas
Rosa Maria Romero

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

Study Coordinators
Izar Achaerandio
Carlota Aguilera
Alejandra Caballero
Iris De La Fuente
Elena Fernandez
Laura Garcia
Patricia Garcia
Irene Garrido
Cristina Pérez
Iratxe Puebla
Sergi Recasens
Andrea Retter
Eulalia Scheenaard
Sandra Tijeras
Lorena Trejo
Román Vidal

Data Managers
Laia Gregori
Raquel Gutierrez
Eva Mª Lázaro
Eva Marín
Silvia Marín
Sergio Pérez
Asal Rinaldi
Julia Serra
Eduard Solà

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

Study Coordinators
Judith Alonso
Enric Álvarez
Beatriz Bruno
Nuria Collantes
Carlos Fernandez
Sergio Fernandez
Berta Garrido
Alba Meire
Thaïs Miquel
Olga Padrós
Mariona Pocarull
Angela Maria Quintana
Ester Serra
Anna Serrano

Data Managers
Cristina Aguilar
David Alvarez
Marta Batista
Maria Isabel Martinez
Carina Monclús
Nuria Ortega

Head, Clinical Research Support Unit
Susana Muñoz

Sample Managers
Gemma Pruna
Cristina Resina

Clinical Trials Office Administrative Support
Núria Carballo
Cristina Garcia
Marc Palomar
Alexandre Valle

Quality Manager
Silvia García

SUMMARY

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

In 2017 we had 355 Phase I, Basket studies, Phases II & III trials with active recruitment during the same year (see Figure II), with patient enrolment totaling at 1096. 100 new trials were initiated, including 20 post-authorisation trials and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2017 and are still enrolled and receiving study treatment (more than 1800 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 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 sites are chosen based on their high standards of quality and capacity for carrying out state-of-the-art research. We have taken part in early phase trials of different drugs, ultimately enabling the pharmaceutical industry to market novel anti-cancer medicines. We participate in both 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 of patients enrolled in Clinical Trials (Phases I + Baskets - II – III)


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


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

  • Our Clinical Research Support Unit, which was set up in 2016, continues to guide investigators with the start-up and management of independent research lines.
  • We continue to report important numbers of clinical trials performed and respective patient recruitment.
  • 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 and 1 inspection by the European Medicines Agency (EMA) have been conducted with satisfactory results.
  • Continue with the high standard of quality and procedures achieved through the Inspection for Accreditation of the phase I Unit, the Research Unit for Molecular Therapy of Cancer (UITM) – ”la Caixa”, by the Generalitat de Catalunya, carried out in 2016.
  • Improved sample management through the incorporation of 2 sample managers who are responsible for correct log registration of study samples and also help study coordinators with shipments.
  • Expansion of office space available for the coordination and monitoring of our activities.

HORIZONS 2018

  • 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 Clinical Research Support Unit that launched in 2016.
  • 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 13th edition of oncology clinical trials post-graduate course.
  • Optimal data completion and exploitation using the 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.
  • Integrate VHIO’s Experimental Hematology Group study coordinators within our  team in order to align processes and Standard Operating Procedures (SOPs).