Innovations In Clinical Neuroscience

Summit 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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The Early Psychosis Screener (EPS): a v alidated, accurate, web-based, self- report screener for prodromal and early psychosis Presenters: Brodey BB, Girgis RR, Favorov OV, Addington J, Perkins DO, B earden CE, Woods SW, Walker EF, Cornblatt BA, Walsh B, and Zweede EA Affiliations: TeleSage, Inc., Columbia, New York State Psychiatric Institute, UNC-Chapel Hill, Department of Biomedical Engineering, University of North Carolina at Chapel Hill, University of Calgary, Hotchkiss Brain Institute, Department of Psychiatry, UNC-Chapel Hill, Department of Psychiatry, School of Medicine, University of North Carolina at Chapel Hill, UCLA, Departments of Psychiatry and Biobehavioral Sciences and Psychology, Yale, PRIME Psychosis Prodrome Research Clinic, Emory University, Departments of Psychology and Psychiatry, Zucker Hillside Hospital, Department of Psychiatry Research, Yale, PRIME Psychosis Prodrome Research Clinic Background/Objective: Identifying individuals with a high risk of developing a psychotic disorder is critical to many CNS clinical trials. The Structured Interview for Psychosis-risk Syndromes (SIPS) has been the "gold standard" assessment, while the Prodromal Questionnaire-Brief Version (PQ-B) has served as a less rigorous self-report screener. Unfortunately, these assessments suffer from high false positive rates and low predictive value. These deficiencies complicate the efficient conduct of CNS clinical trials. Design: We aimed to develop and validate a self-report assessment that will accurately identify individuals who are at high risk of developing a psychotic disorder within the next 12 months or who have recently developed a psychotic spectrum disorder. Methods: The validation included eight academic facilities, 107 nonclinical controls, and 262 clinical participants. All participants were given the PQ-B and EPS items, and all clinical participants were given the SIPS. All participants were followed for 12 to 24 months. A support vector machine classifier was developed to differentiate nonpsychotic from psychotic outcomes. The classifier's performance was cross-validated using t he leave-one-out approach. Results: The false positive fraction was 51.9 percent for the PQ-B and 11.3 percent for the EPS. Among participants who were identified as clinically high risk u sing the SIPS, the PPV of the PQ-B, SIPS, and EPS were found to be 22 percent, 23 percent, and 38 percent, respectively. Conclusion: The EPS appears to be more accurate at identifying individuals who are either prodromal or in the early stages of a psychosis than either the SIPS or the PQ-B. Because the EPS is accurate and brief, it is ideal for screening individuals for admission into clinical trials relating to prodromal and early psychosis. Disclosures/funding: This research was supported in part by a grant from the National Institutes of Mental Health, which was awarded to TeleSage, Inc. Dr. Brodey is Chief Executive Officer of TeleSage, Inc., and Dr. Zweede is employed by the company as a clinical research specialist. Innovation implemented: Changing Otsuka's business model through the ePlatform Presenters: Nyilas M, Jadhav P, Skubiak T, Whitmore L, Spiller N, Brewer C Affiliations: Otsuka Pharmaceutical Development and Commercialization, Inc. Background/Objective: Our objective was to shift to the ePlatform, a full digital trial platform, by implementing technologies to improve the quality and efficiency of our clinical studies to develop solutions for patients much sooner than the traditional model allows. Design: Our eTrial solution comprises elements including as eSource, eConsent, eScanning, and eSurveillance. Every component has been full tested and validated, in addition to being Health Insurance Probability and Accountability Act (HIPAA) compliant following Food and Drug Administration (FDA) guidelines. Results: Two individual components of the ePlatform were successfully piloted in 2012. In 2016, Otsuka successfully piloted the full ePlatform in a Phase III study with an added challenge of locking the database within 7 2 hours of the last patient visit. Upon successful completion of both challenges, Otsuka made the strategic decision to use the ePlatform model for all studies. To date, Otsuka has s uccessfully completed two trials utilizing the full ePlatform. Two Phase III and two Global Phase III trials are live. All additional studies planned over the next 18 months will be utilizing the full ePlatform. The optimization of activities, such as reduced monitoring frequency and narrative authoring, have been cut at least in half, producing tangible business results for the organization as a whole. Conclusion: As pioneers and leaders in the effort to bridge healthcare and the power of digital technologies, Otsuka's entire organization is embracing research and development culture. Software has become a new core competency within our organization. By re-engineering our internal capabilities into one integrated system, the execution of a digital clinical trial and submission has become reality. Technology-enhanced learning for researchers to support of capacity building in clinical development Presenters: Whitty J 1 , Whitty S 1 , Whalen J 2 , and Sheehan D 3 Affiliations: 1 Faculty of Capacity Development, 2 BTC Network, 3 University of South Florida Background: A global capacity- building program is needed to deal with the complexity of developing new medicines and managing public health in an era when diseases rapidly cross borders and the skills for drug development and the management and analysis of routinely collected data are scarce. Neither the infrastructure nor the number of sufficiently trained personnel is adequate to significantly address this problem, adversely affecting the productivity and quality of life of many citizens. The challenge is to develop a sustainable ecosystem that supports a researcher's professional advancement and their organizations capacity development. Members of the Faculty of Capacity employ new tools and advanced methodologies to design, execute, and manage our academic and mentoring ICNS Innovations in Clinical Neuroscience • November–December 2017 • Volume 14 • Number 11–12 • Supplement S6

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