Identification and validation of biomarkers for autism spectrum disorders
The next paper in Nature is online: nature
The EU-AIMS Longitudinal European Autism Project (LEAP) is the largest clinical observational study in the world that combines genetics, neuroimaging, cognitive testing and clinical assessments. Even if potential new compounds for ASD are found, there are still considerable challenges in testing them in clinical trials, given the lack of qualified biomarkers and the extreme heterogeneity of the ASD population. The EU-AIMS LEAP study aims to identify biomarkers for ASD that can also act as population stratifiers and potentially as endpoints in clinical trials.
EU-AIMS and the European Medicine’s Agency (EMA) have come to a shared understanding of criteria and methodologies for the identification of biomarkers and additional measures for success, which is reflected by the EMA’s issuance of Letters of Support which have been made publically available on the agency’s website