CDISC and Cohen Veterans Bioscience Partner to Establish the First Therapeutic Area Standard for PTSD

The Clinical Data Interchange Standards Consortium (CDISC) and Cohen Veterans Bioscience today announced a collaboration to establish a new CDISC Therapeutic Area Data Standard for post- traumatic stress disorder (PTSD).

Creation of a Common Dictionary for PTSD Will Facilitate Research Data Exchange

Approximately 7 to 8 out of every 100 people will experience PTSD at some point during their lives and about 8 million adults have PTSD in a given year, according to the U.S. Department of Veterans Affairs National Center for PTSD.

While there is a wealth of scientific research on PTSD’s more than 100,000 peer-reviewed scientific articles have been published on the topic across the globe during the last 35 years without a common language this valuable research cannot be effectively shared.

The CDISC and Cohen Veterans Bioscience collaboration will map the most common data elements and biomedical concepts used in PTSD to establish uniform clinical research and terminology standards. This will be accomplished by collecting, tabulating, analyzing and then standardizing data for PTSD medical research and clinical care, collected within the US National Institutes of Health, Department of Defense, Veterans Affairs and other key organizations.

To date, CDISC has developed and made publically available clinical data standards for more than 25 disease areas and disorders, including Traumatic Brain Injury (TBI), which are being implemented in clinical research studies and regulated clinical trials. CDISC standards are considered the gold standard for medical research around the world and are widely used in more than 90 countries for study planning and data collection, tabulation, and analysis. They are required by the U.S. FDA and other regulatory agencies internationally for evaluating new treatments for various diseases and afflictions.

Building upon our work in TBI, we are pleased to be launching another project that can lead to a greater understanding of mental health and better care for those suffering from PTSD. Developing a data standard for PTSD is an important step for CDISC, and for the many patients and families that experience this condition, and we appreciate Cohen Veterans Bioscience’s offer to fund the project,” stated Bron Kisler, Vice President, Strategic Alliances & Development for CDISC. The PTSD project is timely, as CDISC is also working on standards for PTSD & TBI comorbidity Major Depressive Disorder, General Anxiety Disorder, and Bipolar Disorder funded by FDA as well as donations from the Association of the US Army North Texas & the Golden Rule Family Foundation.”

The sharing of information in the development of new therapeutics is a mounting problem. While billions of dollars are spent on clinical research, clinical trial data is frequently not shared or is not collected in a standard, sharable format.

To address this practice of siloed research,” the Clinical Data Interchange Standards Consortium (CDISC) an Austin-based, global, non-pro t organization has led the charge for data synchronization, developing and supporting global data standards to help improve the quality and interoperability of medical research and healthcare.

Establishing a suite of standards to support clinical research from protocol and data collection through analysis and reporting is an important tool that will accelerate the development of new and effective diagnostics and treatments for our service men and women and veterans that are affected by PTSD,” says Magali Haas, MD, PhD, CEO & President of Cohen Veterans Bioscience. Empowering data collection and sharing makes the most of the valuable information offered by patients participating in research studies around the globe and saves time and resources to unlock cures sooner.”

About the Clinical Data Interchange Standards Consortium (CDISC)

CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world.

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About Cohen Veterans Bioscience (CVB)

Cohen Veterans Bioscience is a non-profit 501(c)(3) biomedical research and technology organization dedicated to advancing brain health by fast-tracking precision diagnostics and tailored therapeutics.

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