May 20 is dedicated to remembering the importance of clinical trials and the scientific evidence they provide to improve the health of thousands of people around the world. WHO defines "clinical trial" as "any research study that prospectively assigns one or more health interventions to human participants or human groups in order to assess the effects on health outcomes". Research is key to increasing scientific knowledge and delivering new therapies that benefit patients. The celebration of International Clinical Trial Day takes its symbolic date of that day in 1747 when Dr. James Lind completed the first successful clinical trial in history, aboard the Salisbury, where he discovered with his research that the Vitamin C deficiency was the cause of scurvy on British sailors.
The pandemic has been a challenge in many ways. Within the field of clinical trials, research against Covid-19 has become one of the axes of the research groups of the Vall d’Hebron Research Institute (VHIR). An example of this scientific activity is the publication of more than 300 articles on COVID-19 with the participation of professionals from Vall d'Hebron since the beginning of the pandemic and, above all, the creation of a multidisciplinary work environment (a Task Force made up of more than 190 researchers) whose main objectives are to coordinate the efforts of all the professionals involved and facilitate the work of researchers in the publication of COVID-19 papers and in the achievement of competitive projects. These professionals belong to 28 research groups (27 from the VHIR and one from the VHIO), 31 care services of the Hospital, Scientific-Technical Services of the VHIR (the Statistics and Bioinformatics Unit and the Biobank), the Directorate of Systems Information on the IDIAP Jordi Gol Hospital and Primary Care Center. The researchers are organized into 22 multidisciplinary subgroups, each focusing on a specific aspect of Covid-19.
Among the many recent studies, for example, Vall d’Hebron has been the first center in Europe to begin a clinical trial with a new system to filter blood and improve the evolution of COVID-19; has been part of the recruitment of volunteers to participate in the phase III clinical trial of the Covid-19 vaccine from Janssen Pharmaceuticals (Johnson & Johnson); and late last year became the first center worldwide to include a patient (a 5-year-old) in Pfizer’s Phase 3 Gene Therapy Clinical Trial for Duchenne Muscular Dystrophy.
In addition to the commitment to research against Covid-19, throughout the Vall d'Hebron Campus (which includes the VHIO and the VHIR as research centers), during 2020 the record figure was reached in active clinical trials (1,365) and new clinical trials (319). In 2019 there were 1,313 active clinical trials and 317 new ones were launched.
By research area, 62% corresponds to the VHIO. The other 38% is carried out in the VHIR, distributed as follows: 7% in the area of Vascular Biology and Metabolism, another 7% in Neurosciences, 6% in Immune-mediated Diseases and Innovative Therapies, a 5% in research in Pediatric Oncohematology, 4% in Infectious Diseases, 4% in Digestive and Liver Diseases, 2% in the area of Obstetrics, Pediatrics and Genetics and 3% in other lines of research.
EU-PEARL, the adaptive clinical trial platform of the future
On the other hand, it is necessary to emphasize the EU-PEARL project (EU Patient-cEntric clinicAl tRial pLatforms), a unique public-private strategic alliance to conceptualize and lead the design of an integrated, patient-centered research platform for development of new drugs in Europe. EU-PEARL brings together 36 world-leading institutions from European university hospitals, research centers, patient groups, non-profit companies and pharmaceutical companies, under the leadership of Vall d'Hebron and Janssen, to shape the platform of adaptive clinical trials of the future.
EU-PEARL aims for integrated research platforms (IRPs) to become the new model for conducting clinical trials fleeing the current model, in which only one compound is tested in each trial. These collaboration platforms have the participation of multiple companies, are focused on the interests of patients and are specifically created for the development of new drugs.
This way, more patient-friendly clinical trials will be designed, both in terms of design and results-oriented methodology. Initially, EU-PEARL focuses on four diseases: major depressive disorder, tuberculosis, non-alcoholic steatohepatitis and neurofibromatosis, but the will is that, in this framework, the foundations can be laid for designing and executing more integrated research platforms for other diseases. More information on EU-PEARL can be found at this link.
The key research of the VHIO
In Vall d'Hebron, 6 out of 10 clinical trials are conducted at the Vall Hebron Institute of Oncology (VHIO), which established its Office of Clinical Trials in 1997. This is subdivided into teams of Start-ups and Alliances, Coordination and Data Management, which support phase I, II, III and IV clinical trials from industry or academic groups, including studies promoted by the VHIO researchers themselves. In 2020, the office has managed 791 clinical trials (211 phase 0-I, 245 phase II, 272 phase III and 63 phase IV) in which 1,435 patients have participated. Despite the pandemic and thanks to the efforts of all the professionals involved, the activity of clinical trials in the areas of Oncology, Hematology and Radiotherapy was maintained. It should also be noted that more than half of the clinical trials are in the early stages and are carried out in the Cancer Molecular Therapy Research Unit (UITM) - CaixaResearch, a reference unit in Europe dedicated to carrying out complex clinical trials with drugs in early stages of development, focusing on new specific molecular targets.