Post Traumatic Stress Disorder Therapeutic Area User Guide review
A Post Traumatic Stress Disorder Therapeutic Area User Guide (TAUG-PTSD) has been released for review.
The TAUG-PTSD v1.0 describes how Post Traumatic Stress data should be recorded in a standardised 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.
To review the user guide, see: PTSD Public Review.
CDISC invites you to attend the webinar for the PTSD Public Review 26 SEP 2017 10 AM – 11 AM CDT USA.
The review period for the TAUG-PTSD v1.0 runs through 13 NOV 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.
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 see 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 - See https://www.cohenveteransbioscience.org/.
22 September 2017.