The last day of 2015 saw researchers from European Autism Interventions – A Multicentre Study for Developing New Medications (EU-AIMS) announce a partnership with the European Medicines Agency (EMA).
The collaboration will pull representatives from the largest multi-center study in the world for the development of possible autism therapies and the EMA together to choose study participants and evaluate the efficacy of new medications and treatments.
Autism Speaks has been a major contributor to EU-AIMS research and programs.
“We now recognize the enormous diversity among people with autism spectrum conditions,” Eva Loth, EU-AIMS project science coordinator and deputy lead clinical researcher, said. “We need to move away from the idea of a one-size-fits all treatment for autism. We believe that it will be more fruitful to develop treatments – medical and non-medical – for different persons with autism depending on their specific needs.
To do this, it is vital to have clearly defined biomarkers, or biological measures, to identify subtypes of autism and match them with the treatments most likely to provide benefit."
One of the major studies being conducted by EU-AIMS is the Longitudinal European Autism Project (LEAP), which includes genetic testing, neuroimaging, cognitive testing and clinical assessments. Researchers are looking to enroll 400 children and adults with autism and 300 children with typical development or mild intellectual impairment in the multi-center study.
"It's critical for researchers to engage with the drug regulators early on, to figure out exactly what will be required to prove that a treatment is safe and effective for persons with autism,” Autism Speaks Vice President for Medical Research Paul Wang said.
One of the most important parts of the study will be the research of autism biomarkers.
“Basic science is now at the brink of being able to identify molecular mechanisms and to translate them into effective therapeutic targets for treatment of individuals with [autism spectrum disorder] ASD,” the researchers wrote. “Validation and qualification of ASD biomarkers will be key to giving industry the confidence to carry out the costly, large-scale clinical trials needed to assess the efficiency and mechanism of therapeutic interventions, delineate the patient populations that will benefit from them, and facilitate the regulatory approval of new therapies.”
Collaboration to support European efforts in autism research