Health Services of MadridHospital General Universitario Gregorio Marañón, Servicio Madrileño de Salud, Madrid, Spain
Hospital General Universitario Gregorio Marañón (HGUGM), which is part of the Health Services of Madrid (Servicio Madrileño de Salud; SERMAS), is the largest university hospital in Spain. For the past eight years, it has been the coordinating centre for the Spanish Psychiatric Research Network (CIBERSAM), a consortium funded by the Spanish Ministry of Science and Competitiveness, which comprises 25 centres and more than 400 researchers.
SERMAS-HGUGM has a long tradition of research in neurodevelopmental conditions including autism, genetic disorders, and psychosis. The centre is participating or has previously participated in several FP7, H2020, and other European-funded research projects such as ERANET-NEURON, EU-GEI, OPTIMISE, METSY, and PSYSCAN. SERMAS-HGUGM is the only hospital in Spain with a programme specifically for meeting the medical needs of autism spectrum individuals (AMITEA; Parellada et al., European Psychiatry 2013), and the study of the underlying biological mechanisms of autism spectrum disorder (ASD). It has been regionally and nationally recognized as a clinical good practice resource for the care of autistic individuals and is therefore included in the Ministry of Health’s National Strategy for Mental Health Care. The team consists of a multidisciplinary team, including clinical and research psychiatrists, clinical and research psychologists, neuropsychologists, nurses, and lab technicians, as well as experts in multimodal neuroimaging, data management and processing, and statistics.
Role in AIMS-2-TRIALS
SERMAS HGUGM will contribute its expertise in data harmonization and clinical phenotyping, and its experience in conducting randomised control trials (RCTs), including hypothesis-driven research. SERMAS will also be involved in recruiting participants to take part in research projects and currently has a potential cohort of more than 2,000 people Within the project, SERMAS HGUGM will be leading Testing New Medicines, but will also be involved in the European Clinical Research Network and data modelling.
SERMAS is leading Testing New Medicines, which involves creating a viable and strong network of sites across Europe to conduct randomised control trials. These trails will assess the efficacy of a drug that targets core and/or co-morbid symptoms in ASD. This will be achieved by facilitating focus groups, consultation, and meetings with reference experts., We will develop a protocol of improved trial designs to carry out studies to access efficacy with existing medications used for other purposes and innovative approaches in patients using a stratified medicines approach. This will be developed on the basis of pre-existing and/or new markers identified in the Biomarkers of Autism project.
Together with the European Clinical Research Network, SERMAS will support the development of a clinical network to improve drug assessment. This network will facilitate the preparation of an industry-sponsored clinical trial by identifying 11 potential sites across 5 countries, and subsequently assess novel medication therapies for ASD. SERMAS will lead on the Spain, Portugal, and Italy hub for trial-ready sites to provide trial infrastructure and initial funds to launch studies at the recruiting centres. Together with UMCU, SERMAS will provide training in Good Clinical Practice and high-quality trial implementation using a ‘hub-and-spoke’ train-the-trainer model via a mix of face-to-face workshops and webinars.
As part of modelling data SERMAS will identify implementation barriers and how they vary across the EU; in particular, differences in evidence that payers require before approving of new treatments, medical and other devices developed by our consortium, and/or specific types of biomarkers. In addition, SERMAS will ensure a future-oriented reimbursement strategy by developing, marketing, and launching CE marked medical devices for the healthcare sector. SERMAS will also support the regulatory alignment of USA and EU led by Roche to achieve a better understanding of regulators’ views and determine requirements on a range of key issues influencing Projects across the research programme, enabling more rapid development of (regulator approved) biomarkers, objective outcome measures, and treatments.
Celso Arango López
Research Assistant and PhD Student
Maria Luisa Dorado
Alicia Garcia Alcon
Javier González Peñas
Maria José Penzol
Laura Lopez Moreno
Covadonga Martínez Díaz-Caneja
Psychiatrist and Research Coordinator
Antonia San José Cáceres