Establishing universal standards for data collection
PTSD Therapeutic Area User Guide v1.0
In partnership with the Clinical Data Interchange Standards Consortium (CDISC), we published the first Therapeutic Area (TA) Standard for PTSD. The guide describes how data should be recorded in a standardized database, establishing best practices across the clinical research industry for recording, reporting, and sharing disease-specific data. Using the guide can facilitate regulatory submissions for novel therapies and allow the research community to easily compare data from different studies. This guide is critical for the future of data integration and collaboration that can accelerate the discovery of better diagnostics and treatment options for PTSD.
We hope researchers will use this user guide to bring clarity to the data and discover breakthroughs in PTSD.
– David R. Bobbitt
President and CEO, CDISC
Preclinical Common Data Elements for Traumatic Brain Injury
Big data approaches are critical to accelerating discovery in complex disorders such as traumatic brain injury (TBI). Common data elements (or CDEs) enable big data approaches by providing consistency in the way data is collected, formatted and described from one study to the next. Members of the Cohen Veterans Science scientific team were part of a committee of experts who worked with the National Institute of Neurological Disorders and Stroke to spearhead the development of CDEs for preclinical TBI research.
Enhancing the quality of preclinical data
Global Preclinical Data Forum
The Global Preclinical Data Forum (GPDF) is a jointly sponsored U.S. and European initiative that encourages global collaboration to address the challenge of ensuring that preclinical research is reproducible, robust, and translatable. The GPDF provides training, education, and other resources that address modern issues in preclinical research with the goal of systematically advancing best practices that will enhance the quality of the preclinical data for clinical research and development. Cohen Veterans Bioscience is the fiscal sponsor of the GPDF and part of the GPDF leadership Core Team.
PEERS: The Platform for The Exchange of Experimental Research Standards
Laboratory assays and tests have become increasingly diverse and complex. Confronted with a multitude of information with unclear relevance for their specific experiments, scientists run the risk of overlooking critical factors that can influence the outcome of their studies. PEERS is a community-driven, open access database that will improve the reproducibility of preclinical studies by providing scientists with an expertly curated catalogue of the major factors that can influence the outcome of an experiment when not considered a priori.
Sex as a Biological Variable Video Training Series
Differences between males and females extend far beyond reproduction, with significant implications for human health and disease. This is particularly relevant in neuroscience, where difference in basic biology between males and females translates into sex differences in the prevalence, progression, and responses to treatment of many brain disorders. Cohen Veterans Bioscience developed an unprecedented new video series that provides the practical knowledge necessary for preclinical researchers to incorporate sex as a biological variable into their current and future research. The 18-part video training program was developed to help strengthen the translation of basic research findings to human care and enhance the overall quality of preclinical research.
There are no universally agreed upon guidelines that govern the design, conduct, and analysis of preclinical research. As a result, the development of new medications has slowed dramatically in the last 10 years due to the high risk of failure. The EQIPD project (2017-2021) aimed to reverse this trend by bringing together a consortium of over 20 research groups from industry and academia to develop a simple, strategies to reduce the risks of drug development research and ensure adherence to rigorous research practices. The Guarantors of EQIPD were founded in 2021 to disseminate the developed strategies to the research community. Cohen Veterans Bioscience is a fiscal sponsor of the Guarantors of EQIPD.
Incentivizing the publication of negative data
When science is properly conducted, negative results, or results that do not confirm the expected outcome or original hypotheses, are a natural occurrence. However, much of the science that is published is skewed towards positive results, with some estimates indicating that 85% of all published studies in neuroscience publish only positive results. The end result is a loss of time and money as researchers pursue avenues of scientific inquiry that are bound to fail. Cohen Veterans Bioscience believes that we need a paradigm shift in which negative data is valued according to the same standards as positive data and has taken a number of steps to demonstrate the value of negative data to the scientific process.
Best Negative Data Prize in Preclinical Neuroscience
- Learn more and see the list of past prize winners here.