Amyotrophic Lateral Sclerosis (ALS) is a rare, progressive, fatal neurodegenerative disease affecting the motor neurons. It affects around 50.000 adults in Europe. By now, there is no curative treatment for ALS. Real4Reg aims to improve knowledge about ALS and to optimise the design of clinical trials to develop new medicines for ALS.
As being a rare disease, it can be difficult to have a good knowledge basis about the disease itself. Real4Reg will collect data from 4 European countries, describing the clinical characteristics of the patients, the treatment used, and the progression of the disease.
To assess the efficacy of new treatments, the clinical trials need to have enough patients to receive the new medicine and patients to serve as comparator groups (receiving their regular treatment). In the case of ALS, the relatively low number of patients is a constraint to conducting clinical trials. Real4Reg will use artificial intelligence and machine learning to support regulatory decision-making about treatments for ALS.
The data sources (national healthcare registers and claims data) will be used to simulate the existence of virtual individuals with identical characteristics to the ALS patients. These synthetic data can serve as virtual comparator-individuals in the studies.
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