Innovations In Clinical Neuroscience

Summit 2017

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

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number of drugs that are abandoned due t o the failed response rates. A large percentage of antidepressant and antipsychotic drug trials have failed due to increased placebo response. This is often due to the reliance on patient- r eported outcomes and subjective/objective assessments for the efficacy measures. There are many psychosocial and expectancy factors that might also affect the outcomes of these trials. The increasing occurrence of placebo response among CNS trials is leading to less funding for CNS research, an area that is still in need of new medications for additional indications or insufficient symptom relief. As a consortium of sites, our goal is to develop a site-based program, targeting CNS trials, to mitigate the elevated placebo response. Design: We are seeking to develop material for staff training and patient education targeting minimizing placebo response in CNS clinical trials; provide detailed training to all staff for detailed understanding of protocols and endpoints so they are able to focus on obtaining accurate and unbiased data; develop patient education materials differentiating research and treatment relationships, clinical trial expectations, double-blind, and placebo; and collaborate with pharmaceutical companies to pilot this program using their clinical trials and obtain site specific outcome data to compare program efficacy. Financial disclosure/funding: None reported. The power of an educational placebo response video: strengthening subject placebo response awareness across demographic variables and diagnoses Presenters: Hassman H, Cohen EA, Myers K, Hossain SI, Joseph AV, and Lobb J. Affiliations: Hassman Research Institute Science Division Introduction: The clinical trial industry continues to grapple with increasing placebo responses. One technique that merits empirical exploration is educating subjects on factors linked to their potential increased response to the 'inert' substance. These factors include site- subject interactions, subject e xpectations, lack of subject understanding of the placebo, and subject role uncertainty. Our study investigated whether an educational video would raise subjects' awareness a bout these factors across age, sex, and diagnostic indication, ultimately leading to reducing subjects' response to the placebo. Methods: Patients with a CNS, addiction, or general medicine diagnoses completed a Placebo Awareness Questionnaire (PAQ) to assess awareness of the placebo response key factors. Upon completion of the PAQ, subjects were randomized to the Intervention Group (IG; n=100) where they watched a seven-minute video regarding these factors and completed a post-PAQ. Control group subjects (CG; n=100) completed the PAQ without watching the video. Results: A repeated measures analysis of variance (ANOVA) showed a significant difference between the IG and CG groups such that the IG subjects were better able to identify the placebo response factors after watching the video (p<0.001). Secondary analysis indicated this finding was true across age, sex, and diagnoses (all p<0.05 except for the 20–29 year age group). Conclusion: Within-group analyses suggests a differential effect of the intervention on the subgroups (e.g., IG women scored higher than IG men post- video). Implications are discussed. Disclosures/funding: All authors are full-time employees of Hassman Research Institute and have no conflicts of interest for this work. RATER TRAINING AND ASSESSMENT Distribution of performance and incorrect ratings in qualification video scoring Presenters: Enger B, Barbone JM, and Eckart C Background/Objective: We aimed to answer the methodological question: Do rater training programs utilizing the standard qualification video scoring error remediation process sufficiently contribute to the goal of maximizing rater calibration prior to the start of a study? I ntroduction: A long-held standard in the CNS Clinical Trial Rater Training industry is that in order to successfully complete video qualification scoring and be qualified to rate in a study, raters m ust score 80 percent of the scale items within an acceptable score range set by the consensus of an expert scoring panel. Raters scoring 80 to 99 percent on qualification scoring typically receive no remediation. Raters scoring 60–80 percent are provided a remediation of each item scored out of range, including re-training on the proper scoring for each of the items scored out of range, and are often asked to rescore the video. Raters scoring below 60 percent are neither recommended to rate in the study nor remediated and are not included in this analysis. Design: Rater scoring data from Bracket's rater database across 25 protocols were analyzed for the number of scoring errors on study qualification videos for the Positive and Negative Syndrome Scale (PANSS), Montgomery- Asberg Depression Scale (MADRS), and Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-Cog). Results: For the cohort of trained and qualified raters who went on to administer the scale, the following percentage of qualification scoring errors were not remediated: 61 percent for PANSS, 54 percent for MADRS, and 70 percent for ADAS-Cog. Conclusion: This represents a significant missed opportunity to improve scoring precision at a critical time in the study, prior to the assessment of the first subject. A 100- percent remediation approach would take advantage of this opportunity and could improve rater performance via endpoint reliability findings. Disclosures: This poster was funded solely by Bracket Global, LLC. Identification of Children's Depression Rating Scale—Revised (CDRS-R) items of particular challenge to raters in child and adolescent depression clinical trials outside of the United States Presenters: Busner J 1 , Findling RL 2 , and Robb A 3 ICNS Innovations in Clinical Neuroscience • November–December 2017 • Volume 14 • Number 11–12 • Supplement S16

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