The Massachusetts General Hospital (MGH) Neurological Clinical Research Institute (NCRI) and Prize4Life, a nonprofit organization whose mission is to accelerate the discovery of treatments and a cure for amyotrophic lateral sclerosis (ALS), received a Best Practices Award at the 2013 Bio-IT World Conference & Expo. Presented on April 10, the award acknowledged the creation of the Pooled Resource Open-access ALS Clinical Trials (PRO-ACT) platform.
The PRO-ACT platform was chosen from 33 detailed submissions for the Bio IT World award and was honored in the "Clinical & Health IT" category. The dynamic database helps to accelerate discovery, development and delivery of future ALS treatments by housing the largest dataset from completed Phase II and III clinical trials in ALS. The platform enables the merging of data from global clinical trials, generating a valuable resource for the design of future trials and the identification of novel correlations and disease biomarkers.
The PRO-ACT database, contains more than 8,500 fully deidentified, unique clinical patient records both treatment and placebo data from 17 late-stage industry and academic trials and over 8 million data points, including 1.7 million records of lab test results of ALS patients. "The results garnered through the use of the PRO-ACT platform 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 currently unanswerable questions," states Alexander Sherman, NCRI director of Systems and a pioneering force behind the launch. "It is an unprecedented opportunity to increase the field's understanding of the ALS patient population and the natural history of the disease."
Melanie Leitner, PhD, Prize4Life chief scientific officer says, "We have been thrilled at the ALS community's enthusiastic response to PRO-ACT since its December 2012 launch, including 117 requests to access the PRO-ACT data from industry, clinicians, biostatisticians and other quantitative experts. It is our belief that open access to this rich treasure of data will attract new ideas and shed new light on this disease. We thank Bio-IT World for the opportunity provided by this award to bring PRO-ACT to the attention of the larger Bio-IT community."
NCRI and Prize4Life created the PRO-ACT database with funding from the ALS Therapy Alliance (http://alstherapyalliance.org) in partnership with the Northeast ALS Consortium (http://www.alsconsortium.org/). Academic institutions and pharmaceutical companies including Sanofi, Novartis, Teva Pharmaceutical Industries and Regeneron Pharmaceuticals contributed data to this initiative, and other potential data donations are currently being pursued. Utilizing the datasets should further encourage collaboration between academic and industry researchers, statisticians and clinicians throughout the world.
"The unique collaborative approach used to create PRO-ACT speaks to the advantages of for-profit, nonprofit and academic centers working together," says Merit Cudkowicz, MD, director of the NCRI and chief of Neurology at MGH. "The PRO-ACT initiative has the power to greatly enhance the design of clinical trials testing new approaches to fight ALS and other challenging neurodegenerative diseases."
The capabilities of the database were put to the test last fall during the DREAM-Phil Bowen ALS Prediction Prize4Life Challenge (http://www.prize4life.org/page/news/10194), in which solvers used a subset of the PRO-ACT dataset to develop algorithms to predict the progress of ALS. The outcome revealed PRO-ACT's benefits increased likelihood of successful trials by providing a tool to measure interpatient variability and the potential to reduce the number of patients needed in a trial by 23 percent.
The Bio-IT World's Best Practices Awards program was established in 2003 to highlight organizations for their outstanding innovations and excellence in the use of technologies and novel business strategies that will advance biomedical and translational research, drug development, and/or clinical trials.
|Contact: Devon Punch|
Massachusetts General Hospital