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CDISC and Cohen Veterans Bioscience Announce Public Review for Post Traumatic Stress Disorder Therapeutic Area User Guide
AUSTIN, Texas – (BUSINESS WIRE) – The Clinical Data Interchange Standards Consortium (CDISC) and Cohen Veterans Bioscience announce the availability of a Post Traumatic Stress Disorder Therapeutic Area User Guide (TAUG-PTSD) for public review.
The TAUG-PTSD v1.0 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. Use of the standard will facilitate regulatory submissions for novel therapies. It will also allow the research community to compare and contrast data from different studies more easily, with more scientific rigor, and will make it easier for researchers to understand natural history, biomarker, and trial data in the future.
TAUG-PTSD v1.0 describes the common biomedical concepts relevant to PTSD studies using the CDISC standard format. Concepts covered in the TAUG-PTSD v1.0 include representation of skin conductance, startle response, and sleep data. Questionnaires, Ratings, and Scales of interest for PTSD studies are also referenced in this user guide.
Researchers and clinicians are encouraged to review TAUG-PTSD v1.0 and provide feedback. CDISC relies on input from the clinical research community to ensure neutral, consensus-based data standards are developed and adopted by diverse global stakeholders interested in improving research processes and quality for the benefit of all.
The review period for the TAUG-PTSD v1.0 runs through November 13, 2017.
PTSD is a clinically diagnosed psychiatric condition that can occur following the experience or the 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.
The fast-paced development of this PTSD data standard by the CDISC team was critical for empowering the next wave of data collection and sharing by the global research community and will save time and resources to unlock cures sooner,” commented Dr. Magali Haas, CEO & President, Cohen Veterans Bioscience.
TAUG-PTSD v1.0 was funded by Cohen Veterans Bioscience and developed through the Coalition for Accelerating Standards and Therapies (CFAST) initiative, a partnership of CDISC and the Critical Path Institute (C-Path), with participation from the U.S. NIH National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), FDA, TransCelerate, the Japan Pharmaceutical and Medical Devices Agency (PMDA) and additional stakeholders.
To date, therapeutic area standards have been developed for more than 30 different disease areas.
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About CDISC
CDISC is a 501(c)(3) global nonprofit organization that develops data standards to foster smarter research. CDISC standards allow data to speak the same language by providing common formats for data collection, data sharing and data analyses to make the most of the valuable information offered by patients participating in research studies around the globe, enabling researchers to discover new treatments, find breakthroughs, and unlock cures. CDISC standards are required for regulatory submissions to the US FDA and Japan PMDA, endorsed by the China CFDA, and requested for use by the European Innovative Medicines Initiative (IMI). The suite of CDISC standards is freely available on the CDISC website.
CDISC is funded through the generous support of over 400 member organizations from pharmaceutical, biotech, clinical research organizations, regulatory agencies, academia, and healthcare, as well as through grants, authorized CDISC Education courses, events, and charitable contributions. To find out more about how to support CDISC and get involved, please visit www.cdisc.org.
About Cohen Veterans Bioscience
Cohen Veterans Bioscience is a national nonprofit 501(c)(3) public charity 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.
About the American College of Radiology (ACR) Head Injury Institute
The ACR Head Injury Institute was formed to help advance the diagnosis, understanding and treatment of head injuries. One of the greatest needs in the advancement of head injury medicine is the identification and development of biomarkers such as microscopic structural differences in the brain that can help identify the nature and severity of a head injury. The Head Injury Institute brings a broad and deep range of capabilities and relationships to this challenge.
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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AUSTIN, Texas – (BUSINESS WIRE) – The Clinical Data Interchange Standards Consortium (CDISC) and Cohen Veterans Bioscience announce the availability of a Post Traumatic Stress Disorder Therapeutic Area User Guide (TAUG-PTSD) for public review.
