Open-access database will take researchers one step closer to finding a treatment and cure for ALS
PRO-ACT: The Largest ALS Clinical Trials Database Ever Created
Cambridge, Mass. - December 5, 2012 - Prize4Life, a nonprofit organization whose mission is to accelerate the discovery of treatments and a cure for ALS (Amyotrophic Lateral Sclerosis, also known as Lou Gehrig's disease), announced today the launch of the PRO-ACT (Pooled Resource Open-Access ALS Clinical Trials) database, the largest ALS clinical trial database ever created.
PRO-ACT is a powerful tool that merges data from existing publicly and privately conducted ALS clinical trials and makes these data widely available for research, creating an invaluable resource for accelerating discovery in the field of ALS. Prize4Life and the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital created the PRO-ACT database with funding from the ALS Therapy Alliance and in partnership with the Northeast ALS Consortium (NEALS). Generous data donations came from pharmaceutical companies including Sanofi, Novartis, Teva Pharmaceutical Industries, and Regeneron Pharmaceuticals, as well as academic institutions around the world.
"With the creation of the PRO-ACT database, Prize4Life and the NCRI have given 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 for ALS," said Dr. Doug Kerr, Biogen Idec's Medical Director, Neurodegeneration Clinical Development.
PRO-ACT contains more than 8,500 fully de-identified unique clinical trial patient records, including demographic, lab, medical history, functional scores, and other data elements. The dataset currently includes both placebo and, in most instances, treatment-arm data from 18 late stage (Phase II/III) ALS clinical trials, resulting in over eight million longitudinally collected data points. Prize4Life and the NCRI initiated this project with the belief that making ALS clinical trial data globally available would catalyze more ALS discoveries to happen sooner.
"The vision for PRO-ACT is that the ALS community and other interested researchers around the world will have access to enough data to answer previously unanswerable basic questions, such as, how much does ALS differ between men and women," said Prize4Life's Chief Scientific Officer, Dr. Melanie Leitner. "PRO-ACT will also help to answer more complicated questions, such as, can we identify subgroups of people who may actually have responded to treatment in any of the completed trials."
ALS, a fatal disease, is difficult to predict. Although the average life expectancy of an ALS patient is about three years, some people live for decades, while others succumb within months. This lack of predictability makes the design of clinical trials for potential new treatments a long, costly and complex process. One key to better predictability in the future lies in the past - ALS research will move forward when scientists are able to identify the patterns hiding in the millions of data points in PRO-ACT, which were collected from thousands of ALS patients involved in previous clinical trials.
"As clinicians who see ALS patients every day, we recognize the huge potential impact of having access to vastly more patient data than anyone has ever had before. As just one example, being able to identify factors that determine the rate of progression in people with ALS will allow us to improve clinical trial design," said Dr. Merit Cudkowicz, Director of the NCRI, Neurology Chief at Massachusetts General Hospital and NEALS Co-Chair. "Because of PRO-ACT, ALS researchers will be better able to design trials that need fewer participants."
The results garnered by use of the PRO-ACT database will benefit more than just the scientific and medical research fields; they will also impact ALS patients and their families potentially by giving them answers to their questions about what to expect following diagnosis.
"When my father was first diagnosed with ALS, one of the things my family and I struggled with the most was the time it took for him to receive a definitive diagnosis amid the ambiguity of the disease," said Peter Bowen, former Prize4Life Board Fellow and primary fundraiser for the DREAM-Phil Bowen ALS Prediction Prize4Life Challenge named in honor of his late father, Phil Bowen. "It is my hope that the PRO-ACT database will provide answers which allow doctors to be able to tell an ALS patient and his or her family sooner, rather than later, what the future may hold."
The PRO-ACT database is freely accessible to the global research community for analysis and downloads as of today at www.ALSDatabase.org.
Prize4Life is a 501(c)(3) nonprofit organization whose mission is to accelerate the discovery of treatments and a cure for ALS (Amyotrophic Lateral Sclerosis, also known as Lou Gehrig's disease) by using powerful incentives to attract new people and drive innovation. Prize4Life believes that solutions to some of the biggest challenges in ALS research will require out-of-the-box thinking, and that some of the most critical discoveries may come from unlikely places. Founded in 2006 by Avi Kremer, who was diagnosed with ALS at the age of 29, Prize4Life encourages and rewards creative approaches that will yield real results for ALS patients. For more information, visit www.prize4life.org.
About Neurological Clinical Research Institute
The Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital accelerates translational research in neurological disorders through initiating and testing novel therapies. The NCRI has an extensive history in leading clinical research to find new treatments for neurological diseases including Amyotrophic Lateral Sclerosis (ALS), myasthenia gravis, diabetic neuropathy, stroke, multiple sclerosis, Parkinson's disease, and Huntington's disease. For more information, visit http://www.ncrinstitute.org/.
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