A new database of clinical trials in Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig's disease, should help to accelerate drug discovery and improve study designs for the motor-neuron disease, its sponsors believe.
Set up by Prize4Life and the Neurological Clinical Research Institute at Massachusetts General Hospital, with funding from the ALS Therapy Alliance and in partnership with the Northeast ALS Consortium, PRO-ACT (Pooled Resource Open-Access ALS Clinical Trials) is the largest ALS clinical trial database ever created, said Prize4Life, a US non-profit organisation focused on ALS.
The new resource brings together data from existing publicly and privately conducted ALS clinical trials and makes them widely available for research. Data donations came from pharmaceutical companies including Sanofi, Novartis, Teva Pharmaceutical Industries and Regeneron Pharmaceuticals, as well as academic institutions around the world.
PRO-ACT incorporates more than 8,500 fully de-identified unique patient records from clinical trials, including demographic and laboratory data, medical histories and functional scores.
The dataset assembles placebo and, in most instances, treatment-arm data from 18 late-stage (Phase II/III) ALS clinical trials, resulting in over 8 million longitudinally collected data points.
Lack of predictability
Although the average life expectancy of an ALS patient is about three years, some people live for decades while others succumb to the disease within months, Prize4Life notes.
This lack of predictability makes designing clinical trials for potential new treatments long, costly and complex. ALS research will move forward, Prize4Life says, “when scientists are able to identify the patterns hiding in the millions of data points in PRO-ACT”.
The new database gives “companies like ours cause to rethink priorities and strategies regarding ALS, since the abundant clinical and patient data contained within it will help us develop viable Phase II and Phase III treatments”, commented Dr Doug Kerr, medical director, Neurodegeneration Clinical Development at Biogen Idec.
The PRO-ACT database is freely accessible to the global research community for analysis and downloads at www.ALSDatabase.org.