Heads, Phase I Clinical Trials
Raquel de La Torre
Giovanni De Marino
Lidia Martinez De Arenzana
Rosa Maria Romero
Head, GI, Lung, Head & Neck Phase II-III Clinical Trials
Iris De La Fuente
Eva Mª Lázaro
Head, Breast, GU, CNS, Sarcoma, Gynecological Clinical Trials
Angela Maria Quintana
Maria Isabel Martinez
Head, Clinical Research Support Unit
Clinical Trials Office Administrative Support
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.
Figure I: Annual recruitment of patients enrolled in Clinical Trials (Phases I + Baskets - II – III)
Figure II: Annual Distribution of Phase I + Basket, II and III Trials