WP 04 Clinical Research Development
This workpackage has two main components:
1) WP04 includes two of the to-date largest and most comprehensively phenotyped patient cohorts (infant-at risk study, Longitudinal European Autism Project (LEAP)) to identify biomarkers that predict the development of ASD and that can be used to stratify patient groups.
EU-AIMS Longitudinal European Autism Project (EU-AIMS LEAP)
- Study Protocol: Baseline and Follow-up Phases
- EU-AIMS ACC LONG MRI QA SOP
- EU-AIMS_LEAP Cognitive Testing SOP [including New ET Testing]
2) WP04 built up the largest network of clinical sites in Europe for ASD: total of 93 sites across 37 European countries. EU-AIMS provides the infrastructure, including instruments, regulatory framework, and network of clinical sites.
The objectives of this workpackage are:
- Identify biomarkers of ASD which precede onset of clinical symptoms
- Validate biomarkers of ASD in children and adults
- Identify molecular-physiologic pathways of drug response
- Develop clinical infrastructure
- Develop new standardized clinical and cognitive assessment methods for use in clinical trials, and regulatory framework
- Assess clinical standards and outcome of ASD individuals in the EU, and develop education programs
Academic Lead: Professor Dr. Jan Buitelaar, Radboud University Nijmegen Medical Centre, The Netherlands
EFPIA Lead: Dr. Xavier Liogier d'Ardhuy, F. Hoffmann - La Roche, Switzerland
- Radboud University Nijmegen Medical Centre
- F. Hoffmann- La Roche
- King's College London
- Cambridge University
- University Medical Centre
- Karolinska Institutet
- Eli Lilly and Company Ltd.
- Janssen Pharmaceutica
- Vifor Pharma
- Birkbeck, University of London
- University "Campus Bio-Medico"
- Pfizer Limited
- Autism Speaks
will establish translationally validated, reliable, systems-level biomarkers that can be used across species and in healthy, high-risk and affected human subjects for stratification and characterization, response prediction and early efficacy studies.
will identify molecular biomarkers with an established link to heritable risk for ASD that can be deployed in affected individuals; and for the development and early validation of new compounds.
will yield usable individual mode and multimodal biomarkers for drug development and response prediction.