Established in 1997, our Clinical Trials Office incorporates experts conducting clinical trials at the Vall d’Hebron University Hospital’s (HUVH) Medical Oncology Department, headed by VHIO’s Director Josep Tabernero.

This Office comprises study coordinators, data managers and administrative staff who coordinate phase I–IV clinical trials and also participate in several translational research projects conducted at VHIO. Our team, managed by the Clinical Trials Office Director, Cristina Pérez, is organized into 4 groups; start-up unit, oncology study coordinators, oncology data entries, hematology study coordinators and data entries, covering all tumor types and clinical trials.

In oncology and hematology, in 2023 we managed a total of 276 phase I trials, 29 basket trials, 183 phase II trials, 190 phase III clinical trials, and 3 medical device trials and 81 post-authorization and rollover studies, with active recruitment at some time in the year, and patient enrolment in our oncology and hematology clinical trials totaled at 1,343. In addition, we managed 1 phase II trial, 3 phase III trials and 1 post-authorization study in radiotherapy including a total of 14 patients and we continue to follow up patients who were recruited prior to 2023 and are still enrolled and receiving study treatment (5 patients in total, and 38 in follow-up) in Phase II and III trials.

203 new trials were initiated in 2023, including 22 post-authorization trials and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2023 and are still enrolled and receiving study treatment (1,105 patients in total, and 2,001 in follow-up) in Phase 0, I, II, III and medical device trials. 

Clinical Trials in Oncology

In 2023 we managed 224 phase I, 25 basket, 158 phase II, and 124 phase III clinical trials, and 3 medical device trials with active recruitment at some time in the year (Figure I), with patient enrolment totaling at 1,195 (Figure II). 162 new trials were initiated, including 15 post-authorization trials and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2023 and are still enrolled and receiving study treatment (940 patients in total, and 1,776 in follow- up) in Phase 0, I, II, III and medical device trials.

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 a leading reference in early clinical studies. Reflective of our recognized excellence, VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, directed by Elena Garralda, has been re-accredited by the Generalitat de Catalunya (Government of Catalonia).

As we continue to render personalized medicine more precise by matching therapies to the specificities of each individual patient, the requirements and selection criteria for inclusion in certain studies are becoming more complex.

We are dedicated to expanding our portfolio of trials to ultimately establish new treatment regimens with highly selective drugs. Our Unit continues to fine-tune patient selection criteria to identify those patients who are most likely to benefit from novel therapies, including emerging immune-based treatments, tailored to individual patients’ molecular features. 

Clinical Trials in Hematology

In 2023 we managed 52 phase I, 4 basket, 25 phase II and 66 phase III clinical studies with active recruitment at some time in the year (Figure III), with patient enrollment totaling at 148 (Figure IV). 40 new trials were initiated, including 7 post-authorization trials and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2023 and are still enrolled and receiving study treatment (160 patients in total, and 187 in follow-up) in Phase I, II and III trials.

The prestige of HUVH's Medical Oncology Department is recognized by pharmaceutical and biotechnology companies. It has also become a reference program and selected by the industry to carry out complex clinical trials. The number of participating centers in these studies is highly restricted.

Clinical sites are selected based on the highest quality standards 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. In 2023, we have also collaborated in about 16 investigator-Initiated trials (IITs) in oncology.

• Contribute to the development of novel anti-cancer therapies.
• Consolidation as an international reference for clinical trials in oncology and hematology.
• Guide patients enrolled in clinical trials to comply with the protocol requirements and help them with daily life throughout the duration of their participation.
• Standardize clinical trial processes to ensure optimal quality and the compliance with Good Clinical Practice (GCP).

• We continue to report a high number of clinical trials performed and respective patient recruitment.
• The capacity to optimally manage complex protocols which are increasingly demanding.
• We continuously work on improving workflows with cross-functional teams collaborating in clinical trials.
• The implementation of new tools and procedures to increase the quality and efficiency of research.

Inaugurated in June 2010, thanks to the support received from the ”la Caixa” Foundation, VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch is dedicated to designing and conducting clinical trials in oncology with drugs in early development (phase I and phase II) against novel targets. Occupying a total surface area of 1000 m², our Unit is located within the general area of the Vall d’Hebron University Hospital (HUVH), Vall d’Hebron Barcelona Hospital Campus.

This privileged environment with direct access to patients, coupled with VHIO’s translational approach to research and superb scientific framework, has enabled our unit to establish itself as one of the few comprehensive facilities in Europe to rapidly transform the latest discoveries into actionable insights to benefit patients.The UITM – CaixaResearch incorporates a multidisciplinary team comprised of medical oncologists, clinical trial coordinators and data managers, nurses and nurse technicians, pharmacists, as well as administrative personnel.

By promoting tight connectivity between oncology care and research, we implement novel treatment modalities with selective drugs, and generate insights to guide the individualized treatment of patients - getting the right therapy to the right patient at the right time. 

In 2023, our unit participated in 249 phase I clinical trials with active recruitment at some time in the year, 25 of which are Basket trials. Thanks to our multidisciplinary team we have continued to expand our portfolio of phase I and Basket trials, with 608 patients enrolled. This year, we opened 55 new studies, treated over 1,250 patients throughout the year and performed over 600 first visits. 

Directed by Elena Garralda, research carried out at our unit by VHIO’s Early Clinical Drug Development Group focuses on the development of new drugs based on the molecular profile of each tumor as well as the optimization of treatment regimens using combinations of new agents with those that already exist.

Reflective of VHIO’s purely translational model, our studies are also linked to several research lines led by other VHIO groups, thus connecting molecular biology and optimal tumor models with pharmacology and innovative clinical research. VHIO scientists collaborate in our trials to facilitate biomarker development, achieve a deep understanding of the mechanism of action of anticancer agents, and increase our understanding on the mechanisms of cancer drug resistance.

In collaboration with several other VHIO groups, we co-lead our CaixaResearch Advanced Oncology Research Program (2020-2025), also supported by the ”la Caixa” Foundation.

We also participate in VHIO’s Molecular Prescreening Program that performs molecular analyses of patients’ tumors to select the best possible treatment with the experimental therapies available. Thanks to Ana Vivancos' Cancer Genomics Group and their development of existing applications including an n-Counter (Nanostring) platform, two digital PCR platforms (BEAMing Sysmex and ddPCR, BIO-RAD), and five NextGen Sequencers; MiSeq, NextSeq, HiSeq2500 and NovaSeq6000 from Illumina, and a MinION from Oxford Nanopore Technologies, we are equipped to perform faster and more precise analyses of gene mutations and structural alterations in cancer genomes.

In addition to our clinical trials in oncology, in 2023 our Unit also participated in a total of 27 phase I and II clinical trials in hematology, with active recruitment at some time in the year, and opened 4 new phase I studies. We treated a total of 52 hematology patients throughout the year. 

Optimal patient treatment and care and pioneering research at UITM-Caixa Research would not be possible without the essential collaboration of many other teams of oncology professionals. They include our Clinical Research Oncology Nurses, directed by Mª Ángeles Peñuelas and supervised by Laura Bascuñana, pathologists at the Vall d’Hebron University Hospital’s Molecular Pathology Department, radiologists and interventional radiologists at Vall d’Hebron, our Clinical Trials Office directed by Cristina Pérez, this Unit’s Database Managers, VHIO’s Clinical Research Oncology Pharmacy Unit headed by Isabel Cidoncha, our Academic CRO and Quality & Processes Unit directed by Susana Muñoz and Gemma Sala, respectively, as well as many other healthcare specialists including dermatologists, cardiologists, and ophthalmologists.

• Early clinical drug development and translational research led by our UITM – CaixaResearch clinical investigators and VHIO researchers: expansion of our broad portfolio of promising novel anticancer therapies, across a balanced spectrum of studies. In particular, we focus on first-in-human studies, novel combinations, best-in-class compounds, and a new class of drugs.
• Perform innovative trials, such as basket and umbrella studies, and link clinical research with VHIO's preclinical and translational projects. We also collaborate with various other partners involved in drug development and translational research.
• Molecularly guided early-phase oncology trials to promote drug development. This includes performing molecular analysis of patients' tumors to select the best experimental therapy available, co-develop bioinformatic pipelines for genomic-based medicine, and integrate new mechanistic insights, anticancer drugs and customized molecular diagnostics.
• Early drug development of immunotherapies, focusing on new cytokines, bispecifics, immunomodulatory agents, and treatment combinations, as well as conducting translational research in immune-oncology.

• We have performed several phase I trials, including on complex molecularly selected patient populations (Basket/Octopus trials), and immuno-oncology.
• Reflective of our high quality and standards, we received the phase I accreditation from the Generalitat de Catalunya (Government of Catalonia) in 2023. 
• We have expanded our portfolio of drugs targeting developmental pathways, cell signaling (ERK, MET, FGFR, RET, NOTCH, NTRK), antibody drug conjugates (ADCs), and immunotherapy including BITEs, bispecifics, T-cell engagers, T-cell receptor (TCR) therapies, and cellular therapy products. 
• Developed by VHIO's Cancer Genomics Group led by Ana Vivancos, we benefit from applications that enable us to generate faster results. These include an n-Counter (Nanostring) platform, two digital PCR platforms (BEAMing Sysmex and ddPCR, BIO-RAD), and five NextGen Sequencers; MiSeq, NextSeq, HiSeq2500 and NovaSeq6000 from Illumina, and a MinION from Oxford Nanopore Technologies. We also co-develop customized molecular tests for VHIO's Molecular Prescreening Program; disease-oriented mutation panels for our NGS platforms.
• We have established alliances with several pharma companies as the preferred site for testing their novel and most relevant therapies, including GlaxoSmithKline OCTC, Roche ImCORE, and the Astra Zeneca Partner of Choice Network. New alliances have been built with Abbvie, Amgen, and Janssen.
• Our investigators have successfully expanded the Basket of Baskets (BoB) clinical trial. This innovative study in precision oncology integrates flexible molecular prescreening of patients with the development of new diagnostic tests based on circulating tumor DNA (ctDNA) or gene expression analyses (Nanostring). This platform study allows for testing novel targeted therapies in patients diagnosed with tumors harboring specific molecular alterations who have a high probability of deriving benefit from matched therapies. This academic study, supported by the Cancer Core Europe (CCE) consortium, is co-funded by pharmaceutical companies and has an adaptive design to expand the number of study modules.
• We have introduced Molecular Tumor Board meetings to discuss the most relevant genomic features of complicated cases and evaluate possible treatment options.
• We have launched an advanced cell-based therapy program and are participating in several pharma sponsored trials to evaluate tumor-infiltrating lymphocyte (TIL) therapy. We are also exploring academic TIL products in collaboration with VHIO’s Tumor Immunology & Immunotherapy Group led by Alena Gros.
• In collaboration with several other VHIO groups, we co-lead our CaixaResearch Advanced Oncology Research Program (2020-2025), also supported by the ”la Caixa” Foundation.

Our Unit is ISO 9001:2015 certified and is part of the Medical Oncology Department of the Vall d’Hebron University Hospital (HUVH), Vall d’Hebron Barcelona Hospital Campus. It is thanks to the funding received from the ”la Caixa” Foundation that our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch Clinical Research Onco-Hematology Unit opened in 2020. Equipped with all the very latest technologies, this facility further enables us to provide optimal quality in pharmaceutical care and continue to respond to all regulatory requirements.

We focus on two main areas of clinical research in oncology:

Oncology Pharmaceutical Care Program

Our team of expert pharmacists are specialized in hospital and oncology pharmacy. The unit’s laboratory technicians prepare cytostatics and other parenteral therapies used in clinical trials, as well as closely monitor and follow-up our patients.

Pharmacological Research in Oncology Support Program

This program is directed by our team of pharmacists and laboratory technicians specialized in clinical trials. They are responsible for the management of study supplies including storage, dispensation, and traceability control.

In 2023 they managed drugs used in 896 open clinical trials in oncology and hematology, and 13,158 resupply deliveries/clinical trial supply deliveries. Our cutting-edge system for controlling storage temperature—performing electronic temperature recordings every 5 minutes daily—displays readings on computers equipped with audiovisual alarms as well as an around-the-clock SMS alert system for monitoring and reporting temperature deviations.

Regarding the design and validation of our unit’s drug preparation process traceability system, we ensure qualitative and quantitative quality control of our computerized system.

In 2023 our dispensing staff actively participated in 243 pre-study visits, 184 initial visits, 2,490 monitoring visits, 218 close-out visits, and also successfully passed 24 audits, 4 ISO inspections, and 3 FDA inspections.

Additionally, 62,309 clinical trial drugs have been dispensed and validated by our pharmacists, 16,917 of which were for oral administration, 2,115 for IM/ subcutaneous administration, and 43,382 for IV administration. A total of 175 Standardized Dispensing Procedures for clinical trials have been drawn up and we have performed 1,031 updates of these procedures due to subsequent amendments to protocols or pharmacy manuals. 105 storage temperature data reports have also been prepared by our dispensing team.

We also included 372 antineoplastic therapeutic schedules in our prescription software.

Our Pharmaceutical Care Program for patients enrolled in phase I clinical trials: we performed 1,491 C1D1 visits, 746 screenings, and 1,080 follow-ups, as well as compiled patient diaries and/or instructions for patients (in the absence of documentation provided by the respective sponsor). We have seen a total of 3,246 patients in pharmaceutical care consultations.

• Excellence in the services that we provide to clinical oncology research programs through optimal efficacy, efficiency and safety.
• Management, dispensing, preparation and administration of clinical study drugs according to protocol specifications. Ensure traceability of the entire circuit with the development and implementation of new software.
• Maximized control of storage temperature of samples and preparations.
• Optimal use of a computerized program, IPharma-FUNDANET®, for the management of clinical trial supplies.
• Provision of a pharmaceutical care program for patients in phase I, II and III studies treated with orally administered medicines to improve safety, compliance and the efficacy of these therapies.
• Successful sponsor audits as well as inspections carried out by regulatory authorities.

• Replacing paper medical orders, we have implemented electronic prescription ordering for intravenous (IV) administration medication in our site prescription software.
• We have developed new traceability software that includes global pharmacotherapeutic processes; the prescription, validation, dispensing, preparation and administration of drugs in the oncology and hematology clinical trial settings.
• Our Unit provides clinical and technical support for the prescription, preparation, and administration of cytostatics in clinical trials, as well as e-records of usage and timings.
• Qualitative and quantitative quality control of all parenteral anticancer preparations to guarantee patient safety and protocol compliance.
• ISO9001:2015 certification renewed. Successful sponsor audits, regulatory inspections, and participation in the renewal of VHIO’s Phase I Unit reaccreditation.

Headed by Gemma Sala, VHIO’s Quality & Processes Unit was established in 2020 to further improve quality and standardize processes across all clinical studies conducted at VHIO.

This unit comprises quality and transversal support teams including sample managers and schedulers. We perform various tasks related to clinical trials, develop and implement standard processes, and ensure quality excellence. 

Optimal quality assurance is a critical element of clinical trials and the enhancement of study procedures. All activities comply with Good Clinical Practice (GCP) guidelines and current regulatory requirements, with the rights, safety and well-being of patients remaining the paramount priority.

• Provide cross-support and perform clinical trial activities including scheduling, the management of samples and quality assurance, and the standardization of processes.
• Administrative management of clinical visits, follow-up and treatment of patients participating in clinical trials at VHIO. 
• Standardize and optimize processes and circuits to reduce patient waiting times and provide the best possible service. 
• Establish circuits for the optimal management and processing of clinical trial samples.
• Collaborate closely with all teams involved in clinical trials at VHIO to identify and resolve any intances of non-conformity.
• Conduct periodic quality control and internal audits of documentation, site inspections, circuits and procedures. 
• Obtain renewed certification from the Government of Catalonia of VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch.
• Organization of courses and training sessions in-house including: Good Clinical Practice (GCP), revision of electrocardiogram (ECG), cardiopulmonary resuscitation (CPR).
• Conduct regular training sessions to review and further enhance quality.
• Develop and update Standard Operating Procedures (SOPs) to standardize circuits and provide all necessary trainings.

• Clinical trials in oncology and hematology.
• In 2023, we have collaborated in more than 700 active clinical trials, and have successfully passed 26 external audits, 8 internal audits, 2 U.S. Food and Drug Administration (FDA) inspections, and 1 inspection by the Government of Catalonia for the recertification of VHIO’s VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch.
• Continued improvement of circuits, monitoring to identify and resolve any incidents, and the standardization and optimization of processes.
• We have also participated in the internal training of staff involved in clinical trials.
• VHIO's Moodle learning platform for internal trainings and the SOPs Reading Log.