Innovations In Clinical Neuroscience

2015 Abstracts of Poster Presentations

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

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Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 2 , N U M B E R 1 1 – 1 2 , N O V E M B E R – D E C E M B E R 2 0 1 5 , S U P P L E M E N T C ] 14 Objectives: While research indicate these technologies improve the efficiency and quality of rater- administered and patient-reported o utcome assessments compared to paper instruments (Tiplady, 2014; Williams et al., 2015), little empirical exploration has been conducted investigating how users perceive the technologies in comparison to one another. The current study investigates study coordinator and raters' views on using a variety of technologies being applied within the industry, as well as feedback they receive from subjects regarding their use of the tools. Methods: Site coordinators and raters were anonymously surveyed from US and ROW sites. The sites designated to receive the survey had previously participated in numerous psychiatric and neurocognition studies. The site staff were queried about their experiences using these technologies, receiving clinical feedback from electronic devices, as well as their experience with subjects and/or caregivers using these tools. Conclusion: Obtaining the experiential realities of site staff who utilize assessment technologies is critical to increasing the use and acceptance of the technologies. The goal of this investigation is to better understand site and subject insights regarding these technologies in an effort to address potential shortcoming, leading to their greater usage that will enhance the overall quality of rater assessments. Trends in the qualification and parameters and demographics of participants completing Human Abuse Liability (HAL) trials Presenters: Rusch L, Stapleton S, Copeland B Affiliations: Vince & Associates Clinical Research, Inc. Objective: The primary objective of this study was to assess characteristics of recreational drug users who passed the drug discrimination phase (DDP) of a human abuse liability (HAL) trial. Demographic and substance use profiles are meant to inform future protocol designs on the available subject pool for HAL trials. Methods: Descriptive data were c ollected from recent HAL studies, which included over 260 recreational drug users who met DDP criteria. The data collected included recreational drug use history (i.e., most commonly abused drugs, number of lifetime uses) and demographic information. Results: The most commonly abused drugs within this population were ranked and analyzed for total use, mean and median age, and sex discrimination. Overall the order of abuse by brand included Percocet > Clonzapam > Hydrocodone > Alcohol > Lortab > Oxycontin > Vicodin > Opium, and Ambien. In general, the qualification phase supported successful subject selection based on subject completion rates. The mean and median age ranges were 30 and 28 years of age, respectively and most participants were male (88.3%). Conclusion: The summary of the data collected suggest that within the local geography of the metropolitan Kansas City area, drugs that were used most over the lifetime of enrolled subjects were rank-ordered as DEA Schedule II, Schedule IV, and Schedule III. The demographic data provided outlines the subject type that has high probability of successfully completing a HAL trial. Disclosures: Authors are employed by Vince and Associates Clinical Research, Inc. Rusch LM holds stock in Cara Therapeutics and Acorda Therapeutics. Motivating factors for patient participation and completion in psychiatric clinical trials Presenters: Tireman E, De Vito L, Pina D, Kakar R Affiliations: Segal Institute for Clinical Research Background: A growing number of clinical trials are being conducted in nonacademic clinical practice with the goal of providing evidence of the efficacy and safety of new treatment and devices. In order to conduct successful clinical trials, recruitment of appropriate and reliable subjects is of utmost importance. Enrollment of t he targeted number of participants is essential to conducting a successful clinical trial. Attitudes of participants toward clinical trials is a significant factor on successful recruitment. With growing of complexity and nuances of psychiatric clinical trials in particular, the attitudes of subjects toward participation may vary based upon health status, trial type and phases of the clinical trials. Objectives: In order to successfully conduct a clinical trial, the motivating factors of participants must be considered in order to ensure the appropriate and reliable subject pool to obtain the most accurate and valid outcomes. With growing complexity of psychiatric clinical trials, the motivating factors and attitudes of potential subjects can be crucial in avoiding inflated placebo response. Methods: This is an exploratory survey study using a self- administered survey. One hundred subjects participating in numerous different psychiatric clinical trials completed a questionnaire inquiring about motivating factors of their participation in the trial. The questionnaire consisted of three questions: the first assessing the method of recruitment of the subject and the second and third assessing the motivating factors of participation and completion of the trials in which the subjects were participating. A Chi-square test was used to determine differences in categorical data. A t-test was used to explore differences in the means of variables. Conclusion. Yet to be determined. The complexion of risk and error in patient selection for CNS clinical trials: detailed findings from a 16,000-patient eligibility review database Presenters: Nations K, Reinhold C, Miloslavich K Affiliations: INC Research Objective: This analysis aims to

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