EMA Agrees to Autism Biomarkers
The EU-AIMS Longitudinal European Autism Project (LEAP) is combining genetic testing, neuroimaging, cognitive testing and clinical assessments to identify biological risk markers associated with subtypes of autism.
European Autism Interventions – A Multicenter Study for Developing New Medications (EU-AIMS) – the largest multi-center study of potential autism medicines – announced it has forged an agreement with the European Medicines Agency on procedures for selecting study participants and assessing the effectives of new treatments.
The EU-AIMS Longitudinal European Autism Project (LEAP) is combining genetic testing, neuroimaging, cognitive testing and clinical assessments to identify biological risk markers associated with subtypes of autism with the goal of providing researchers with the ability to identify which subtypes best respond to different treatments.
The regulatory agency also agreed on the importance of further study of LEAP’s proposed biomarkers for autism. These include the results of brain-imaging tests that can track brain activity and connectivity, eye-tracking studies that measure attention to social cues and analysis of biological samples such as blood, saliva and urine. Biological samples are particularly important for identifying genetic risk factors that may contribute to some forms of autism.
Read the full release from Autism Speaks.
Managing Medical Devices in Digital Trials: Q&A With Flo Mowlem of ObvioHealth
April 10th 2024Following a webinar on the use of a medical device in a migraine clinical trial, Mowlem caught up with ACT to discuss her biggest takeaways and what she is currently seeing in the digital trials space.
An Examination of the Use of Patient Recruitment and Retention Tactics for Global Studies
March 18th 2024In light of scant published data from sponsors and contract research organizations on site activation and recruitment challenges following the COVID-19 pandemic, the primary objective of this research is to revisit the results of recruitment and retention tactics in studies conducted in 2012 and 2019.
