Cambridge, MA - Prize4Life and the Massachusetts General
Hospital (MGH) Neurological Clinical Research Institute (NCRI) 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 8,600 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 from 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's 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 treasure trove 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
in partnership with the Northeast ALS Consortium.
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 PRO-ACT platform were put to the test last fall
during the DREAM-Phil Bowen ALS Prediction Prize4Life Challenge,
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. Prize4Life sponsored the challenge in
partnership with the DREAM Project.
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 strategies to advance
biomedical and translational research, drug development, and/or clinical
"We extend our sincere congratulations to the winners
of this year's Bio-IT World Best Practices Awards competition," says Kevin
Davies, editor-in-chief of Bio-IT World.
"Our select judges enjoyed evaluating the dozens of excellent entries
received this year and believe that the contest has highlighted some truly
innovative, game-changing tools and solutions. Our winners should be very proud
that they have captured the imagination and respect of such a distinguished
The PRO-ACT database is freely
accessible to the global research community for download and analysis at www.ALSDatabase.org.