Coalition for Accelerating Standards and Therapies (CFAST) Announces a Resource for Parkinson's Disease Clinical Development

January 31, 2013

Company News Release

The Coalition for Accelerating Standards and Therapies (CFAST), a joint effort between the Clinical Data Interchange Standards Consortium (CDISC) and Critical Path Institute (C-Path), in collaboration with the National Institute for Nervous Disorder and Stroke (NINDS), announces the availability of an important new resource in the fight against Parkinson’s disease (PD). Parkinson’s disease is a debilitating condition that affects an estimated 1,000,000 in the U.S. and as many as 7,000,000 people worldwide.

This new resource, the Parkinson’s disease CDISC Therapeutic Area Data Standard, provides a defined and consistent way to store, and submit clinical trial data for PD. The new standard will help researchers combine and evaluate data from multiple studies, streamline the efficiencies of new clinical trials, and aid the evaluation of new drugs and treatments for PD.

“The release of PD v1.0 is the culmination of work by a dedicated team of Parkinson’s disease experts and reflects the high level of collaboration between NINDS and CFAST. We are excited that the development of these standards will significantly contribute to advancing PD drug development,” says Dr. Diane Stephenson, Executive Director of C-Path’s Coalition Against Major Diseases (CAMD). CAMD is one of C-Path’s seven consortia and focuses on accelerating therapies for Parkinson’s disease and Alzheimer’s disease.

The U.S. Food and Drug Administration (FDA) has identified PD as one of several disease areas having a critical need for data standards. "The new PD standard will be followed by many new therapeutic area projects that will be developed under CFAST both to facilitate regulatory review and to enable greater sharing, pooling and ultimately increased understanding of data for multiple studies and therapies, to enable researchers to deliver new and improved therapies to patients," states Becky Kush, CEO of CDISC.

“There is significant unmet medical need for effective treatments for PD,” says Dr. Mark Gordon from Boehringer Ingelheim Pharmaceuticals, Inc. “The PD CDISC standards should contribute to alignment and consensus across the industry,” states Dr. Gordon.

Dr. Ken Marek of the Institute of Neurodegenerative Disorders who was engaged in development of the standards stated that, “the inclusion of biomarkers as well as clinical scales in the PD standard will assist with much needed standardization in future clinical studies.”

This release is the latest collaboration between CDISC and C-Path on the development of Therapeutic Area Data Standards. Scientists and researchers can access the standard on the CDISC site: http://www.cdisc.org/therapeutic.