WAYNE, Pa., April 4, 2017 /PRNewswire/ -- Bracket, a leading clinical trial technology and specialty services provider, today announced an agreement with the International Parkinson and Movement Disorder Society (MDS), to develop electronic versions of the MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS) and the Unified Dyskinesia Rating Scale (UDysRS). The migration of these complex scales to an electronic clinical outcome assessment (eCOA) format aims to improve trial conduct and data quality for Parkinson's disease (PD) studies.
The increasing prominence of PD, a progressive disorder of the nervous system that affects movement, drove MDS to prioritize the update of its scales. Today more than 10 million people worldwide are living with the condition, and each year 60,000 people are newly diagnosed in the United States alone.
Bracket has extensive experience working with paper-and-pencil clinical outcomes in Parkinson's disease and other movement disorders. Bracket is creating eCOA versions of the MDS-UPDRS and UDysRS to support efforts to improve data quality in these studies. Both scales require careful clinical interviews of patients, and by migrating these instruments from paper records to eCOA platforms, investigators and pharmaceutical sponsors will be equipped with a more effective method for using these outcomes in clinical trials.
"Clinical trials in Parkinson's disease and other movement disorders are extremely complex and have a high failure rate," said Jeff Kinell, CEO of Bracket. "Fortunately, digitization in clinical trials is improving results, as the logic of eCOA streamlines scoring protocols and compliance. We're proud to partner with MDS to advance PD trials and help address the growing prevalence of the disease at the ground level."
The UPDRS was developed in the 1980s and is the most widely used rating scale for PD in clinical trials. The revision, known as the MDS-UPDRS, was released in 2008 and measures mentation, behavior and mood, activities of daily living and motor functions. The UDysRS evaluates involuntary movements associated with treated PD, measuring on-dyskinesia, off-dystonia, impairment and disability.
The MDS-UPDRS and UDysRS scales are prime candidates for digitization as eCOA will streamline specific trial protocols, including the addition of time stamps associated with administration to ensure scales are administered appropriately. Additionally, eCOA will simplify calculations on how much time subjects report experiencing dyskinesia, dystonia and an "off" state.
Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs. Learn more about Bracket at www.bracketglobal.com
Sagefrog Marketing Group on behalf of Bracket
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