AUSTIN, Texas
CDISC and Cohen Veterans Bioscience are pleased to announce the publication of a new Therapeutic Area (TA) Standard for Post Traumatic Stress Disorder released in the form of a User Guide for data managers, statisticians, programmers and study managers.
PTSD is a clinically diagnosed psychiatric condition that can occur following the experience, or witnessing of, life-threatening events, such as military combat, natural disasters, terrorist incidents, serious accidents, or physical or sexual assault in adulthood or childhood. Not everyone exposed to a traumatic event will develop PTSD; according to the United States National Center for PTSD, about 7 or 8 out of every 100 people will experience PTSD at some point in their lives.
Version 1.0 of TAUG-PTSD describes how Post Traumatic Stress data should be recorded in a standardized database, establishing best practices across the clinical research industry for recording, reporting, and sharing relevant, disease-specific metadata and research data. Using TAUG-PTSD can facilitate regulatory submissions for novel therapies and will allow the research community to compare and contrast data from different studies more easily, with more scientific rigor, and make it easier for researchers to understand natural history, biomarker, and trial data in the future.
“We are delighted to release a standard dedicated to such a vital behavioral health need,” said David R. Bobbitt, President and CEO, CDISC. “We hope researchers will use this user guide to bring clarity to the data and discover breakthroughs in PTSD.”
TAUG-PTSD v1.0 was funded by Cohen Veterans Bioscience as part of their vision of improving data sharing and open science tools for global research in the field of PTSD. The Cohen organization will be one of the first adopters of the standard as they have based their BRAIN Commons Platform on CDISC standards.
“This collaboration with CDISC, and the many academic researchers who gave freely of their time and expertise, was a testament to how important data standards are and how galvanized the field is to move PTSD medical research forward,” said Dr. Allyson Gage, Chief Medical Officer, CVB. “The availability of these platform-independent and interoperable data standards for PTSD is critical for the future of data integration and team science that can accelerate the discovery of better diagnostics and additional treatment options.”
To date, therapeutic area standards have been developed for more than 30 different disease areas. CDISC data standards are developed by a global research community to facilitate impactful data sharing and are required by U.S. FDA and Japan PMDA for new drug submissions.
About 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. www.cdisc.org.
About Cohen Veterans Bioscience
Cohen Veterans Bioscience is a national, nonpartisan 501(c)(3) research organization dedicated to fast-tracking the development of diagnostic tests and personalized therapeutics for the millions of veterans and civilians who suffer the devastating effects of trauma-related and other brain disorders. To support & learn more about our research efforts, visit www.cohenveteransbioscience.org.
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CONTACT
Ann P. White
512.363.5826
awhite@cdisc.org
