A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience
Issue link: http://innovationscns.epubxp.com/i/631092
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 ] 12 was observed in item P1-Delusions, rho=0.63, 0.54, and 0.59 respectively. In studies focusing on negative symptoms, the correlations w ere generally weaker, and the strongest correlations with the CGI were observed in items N2-emotional withdrawal and N4-passive/apathetic social withdrawal, rho=0.49. Significant differences in correlation coefficients among study types (acute, negative, maintenance and non-acute studies) were observed for most individual PANSS items. Conclusion: In 2005, Lucht and colleagues elucidated the relationship between total scores of the PANSS and BPRS and the CGI. Our results indicate that changes in individual PANSS items drive the change in the CGI-S score and these items vary by study population. Thus, data quality evaluations that solely evaluate the total PANSS/CGI relationship may be misleading. This has implications for interpretation of the relationship between the PANSS and CGI in both clinical practice and clinical research. Disclosures: Dr. Daniel and Dr. Kott are full time employees of Bracket Global, LLC. Enhanced protection against duplicate enrollment in clinical trials by collaboration between two independent research subject registries Presenters: 1 , 2 , 3 Efros MD, 1 , 2 Weingard KK, 4 , 5 Shiovitz TM, 4 Kaminsky D Affiliations: 1 Verified Clinical Trials; 2 Accumed Research Associates PLC; 3 Integrated Medical Professionals; 4 CTSdatabase LLC; 5 California Neuroscience Research Background: Presently there exists at least four distinct research subject database registries designed to protect against duplicate enrollment in clinical trials. Historically, the detection of duplicate enrollment was contingent upon the research subject having attempted dual enrollment within the single registry selected by the sponsor of the clinical trial. Prior to the current collaborative effort a CRO or pharmaceutical sponsor would typically adopt only one of the r egistries available for this purpose. While there has been success with this method, collaboration between the two largest and most experienced registries is expected to improve on existing duplicate subject detection. Attempted dual enrollment rates have been most often reported in the range of five percent in clinical trials, approaching up to 10 percent in certain CNS clinical trial indications. Higher rates of attempted dual enrollment are witnessed in healthy volunteer studies. Prior publications and presentations have well established the efficacy of database registries in reducing the incidence of these violations. Two of the largest registries recently began a collaboration to utilize both their databases and detection capabilities in selected clinical trials in an effort to streamline registry services for sites and sponsors and provide superior duplicate subject detection. Objective: To explore how collaboration between (and possible integration of) two independent research subject database registries may enhance detection rates of duplicate subjects and prevent more protocol-inappropriate subjects from entering clinical trials. Methods: Beginning in August 2015, the two largest US-based subject registries began work on combining marketing and operational features to allow maximal duplicate subject detection and (eventually) minimize redundancy for sites and sponsors. The results of this early collaboration will be presented. Results: It is too early in the collaboration to declare inter- operability of two disparate systems. The use of different database inputs (identifiers) and outputs (reports) will require further efforts and testing. However, a combined Subject Registry Authorization Form, covering use of either or both registries, has been approved by several central IRBs. Promotion of the use of both registries, rather than either one individually, to i ncrease duplicate detection, is underway. Methods to allow a single-access point, inter-operability, and a single report covering both registries are currently under discussion. Conclusion: Use of a research subject database registry has been demonstrated to reduce duplicate enrollment in clinical trials while improving safety and data quality. When possible, at least one of these systems should be employed. By integrating the two largest and most successful research subject databases, significantly increased detection rates and protections against duplicate enrollment are anticipated. The impact of electronic administration of the ADAS-Cog on clinical trial data quality Presenters: Feaster HT, Kott A, DeBonis D, Miller D Affiliations: Bracket Global, LLC Background: Prior research has demonstrated that ADAS-Cog error rates among clinical trial raters tend to be upwards of 32 percent on initial administration when using the paper version of the scale (Miller et al., 2011). Objectives: While clinical trials have traditionally relied on paper- based processes, technological advancements are becoming more fully integrated into the conduct of Alzheimer's disease (AD) clinical trials. Methods: An enhanced electronic (eCOA) version of the ADAS-Cog was developed for clinical trials to eliminate or minimize common scoring and administrative errors with the goal of improving data quality and rater reliability. The eCOA ADAS-Cog used in this trial was designed to be equivalent to the paper version of the scale, and was augmented with internal logic, standardized instructions and scoring conventions.