VHIO'S TRANSVERSAL CLINICAL TRIALS CORE SERVICES & UNITS

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Summary

Set up in 1997, the Clinical Trials Office comprises an operational team conducting clinical trials at the Vall d’Hebron University Hospital’s Oncology Department with more than 35 professionals including study coordinators, data managers, administrative staff and quality control. Our office coordinates studies from Phase I to Phase IV as well as research projects, and is divided into three teams to cover all tumor types and trials. In 2015 we conducted 289 actively recruiting trials with patient enrolment totaling at 979 . In addition, we continue to follow up all patients that were recruited prior to 2015 who are still enrolled and receiving study treatment.

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As we strive 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 and treatment approaches, based on each individual’s molecular ‘measurements’ -- thus delivering on the promise of precision medicine in oncology.

The Vall d’Hebron University Hospital’s Oncology Department has gained much prestige which has been acknowledged by the pharmaceutical industry. 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 - chosen for their high standards of quality and capacity to carry out state-of-the-art research. Our hospital has taken part in phase I trials of different drugs and allowed the pharmaceutical industry to market novel therapies aimed against cancer. We consequently participate in clinical trials promoted by the pharmaceutical industry as well as those developed in our department in collaboration with other hospitals.

Clinical Trials Office

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Office Manager
Gemma Sala

Head, Clinical Trials Office for Phase I Trials
Gemma Sala

Study Coordinators
Meritxell Baño
Marta Beltrán
Lluïsa Carbonell
Maria Herranz
Sonia Martínez
Lidia Martínez de Arenzana
Laura Maynés
Adelaida Piera
Josep Roman
Elisabet Sicart

Data Managers
Laia Cano
Gloria García
Montserrat Pujadas
Isabel Rico
Cristina Viaplana

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

Study Coordinators
Alejandra Caballero
Anna Casas
Iris de la Fuente
Cristina González
Débora Moreno
Sheila Nieves
Iratxe Puebla
Mireia Sanchís
Eulalia Scheenard
Montserrat Solà
Natalia Verde

Data Managers
Anna Aguilar
Irene Garrido
Laia Gregori
Sergio Pérez
Sergi Recasens
Andrea Retter
Ingrid Vilimelis

Head, Clinical Trials Office for Phase II –III Cancer Trials (Breast, GU, CNS, Sarcoma, GIST)
Susana Muñoz

Study Coordinators
Judith Alonso
Alba Calamardo
Raquel Espallargas
Violeta Esteban
Berta Garrido
Jordi Humbert
Gina Marés
Alba Meire
Thaïs Miquel
Oriol Nualart
Olga Padrós
Mariona Pocarull
Angela Quintana
Anna Serrano

Data Managers
David Álvarez
Beatriz Bruno
Julia Esteban
Carina Monclús
Rosa María Romero
Ester Serra

Administrative Support
Núria Carballo
Alexandre Gonzalo
Angel Marín
Pau Ruiz-Olalla

Quality Assurance Manager
Silvia García

Strategic Goals / Clinical Trials Office

  1. Contribute to the development of novel therapies against cancer.
  2. Consolidation as an international reference hospital for clinical trials in oncology.
  3. Guide patients taking part in a trial to comply with the requirements of the protocol and help them with daily life throughout this period.
  4. Ensure that the protocol is appropriately conducted from initiation to the close of the respective trial.
  5. Standardize clinical trial processes to ensure optimal quality and the compliance of Good Clinical Practice (GCP).
  6. Provide high quality data adhering to deadlines.
  7. Facilitate the work and communication between the different staff involved in each trial (oncologists, nurses, pharmacists, pathologists, etc.).
  8. To prepare for and successfully pass audits carried out by sponsors and regulatory agencies.
  9. Organize an annual post-graduate course of clinical trials in oncology to train study coordinators, data managers, nurses and CRA’s.
  10. Maintenance of patient data software for clinical trial management and data exploitation (annual statistics, patient activity, etc.).

Highlights 2015 / Clinical Trials Office

  1. Increase in both the number of clinical trials performed and the number of patients included.
  2. Increase in the complexity of the protocols which are increasingly demanding.
  3. We have provided tailored training to our staff in order to improve the quality of their work and expand upon skills.
  4. Implemented new tools and procedures aimed at increasing the quality and efficacy of research.
  5. 7 sponsor audits and 2 FDA inspections have been conducted with satisfactory results.
  6. Improvement and maintenance of new software implemented for clinical trial management.
  7. Organization of a new GCP training course for all oncology staff.
  8. The incorporation of a Quality Manager to improve both the quality and data of our clinical trials.
  9. We offer training to future study coordinators, data managers, nurses, and junior CRAs. Since 2005, we have continued to organize a 40-hour postgraduate course -- 2015 marked the 10th edition.
  10. This year we have also continued to organize a Good Clinical Practice (GCP) course with the aim of ensuring that all our staff involved in clinical trials is suitably trained in GCP. Considering that they participate in several clinical trials from different sponsors, we wanted to offer a unique GCP training course independent of any sponsor in particular. Our course is certified by the Consell Català de Formació Continuada de Professions Sanitàries (CCFCPS), and La Comisión de Formación Continuada del Sistema Nacional de Salud, official Spanish Authorities, and has also been accepted by all the sponsors as well as the TransCelerate platform.

Horizons 2016 / Clinical Trials Office

  1. 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 trials, maintain the high quality offered in-house as well as to our patients, and thus become a reference hospital at global level for novel cancer therapies and precision medicine in oncology.
  2. We aim to update and create new SOPs to ensure the standardization and quality of all procedures performed in clinical trials.
  3. Create new tools and systems to standardize and facilitate procedures for our clinical trials.
  4. Focus on managing Investigator Initiated Trials (IITs).
  5. Continue with our GCP course.
  6. Organize the 11th edition of oncology clinical trials post-graduate course.
  7. Optimal data completion and exploitation using our recently implemented software for clinical trial management.
  8. Accreditation of the phase I Unit by the Generalitat de Catalunya.
  9. Restructuring of the management organization of the clinical trials office.