A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience
Issue link: http://innovationscns.epubxp.com/i/631092
[ 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 ] Innovations in CLINICAL NEUROSCIENCE 13 Results: 101/1009 (10%) of the eCOA ADAS-Cogs reviewed at the initial Screening visit at multi- national sites contained an error in s coring which required a remediation with the rater. This represents a statistically significant reduction (p<0.0001) in error rates compared to the previously reported 32 percent found with the paper version of the scale. Conclusion: The use of a eCOA eADAS-Cog, designed with enhancements beyond the paper- pencil version and coupled with an in-study ratings surveillance program to identify errors in scoring, can significantly improve data quality by reducing rater error, enhancing standardized administration/scoring of the scale, and minimizing rater drift over the course of the trial. Disclosures: All authors are employees of Bracket Global LLC. A retrospective analysis of the effects of protocol design on completion rates in Phase I studies in subjects with stable schizophrenia or schizoaffective disorder Presenters: Krefetz D, Brown J, Ridolfi E Affiliations: PRA Health Sciences, Early Development Services Objective: To study the impact of protocol design on individual completion in Phase 1 studies in subjects with stable schizophrenia or schizoaffective disorder. Methods: The authors examine the effect of nine trial design variables on individual completion in 11 Phase I trials in subjects with stable schizophrenia or schizoaffective disorder that enrolled at two clinical research sites during the period 2009 to 2014. These 11 trials enrolled 337 subjects and had an overall completion rate of 84 percent (ranging from 75–96%). The variables studied include length of inpatient period, length of outpatient period, longest period between outpatient visits, total time from randomization to final visit, number of outpatient visits, number of arrivals to the site, whether subjects could remain on standard of care antipsychotics, whether the study was placebo-controlled, and the a dministration route of the investigational product (enteral versus parenteral). Variables are analyzed via a stepwise linear regression analysis to assess the predictive value of each variable with regard to study completion. Results: The predictive strength of each trial design variable on subject study completion will be presented. Conclusion: Conclusions can be drawn that inform study design for better subject retention. Advantages of utilizing an SSRO management model to complement neurocognitive vendor or pharmaceutical sponsor data review Presenters: Rissling A, Holland D, Parris B, Usala A Affiliations: CTMG Inc. Background: Neurocognitive rater training and certification coupled with ongoing data review by an external neurocognitive vendor increases data reliability. However, without design reviewed internal quality systems at the investigative site, the quality of neurocognitive data submitted to a vendor is dependent upon each site's internal processes. External recognition of data issues and implementation of remediation is hence often delayed. The Site Specific Research Organization (SSRO) model applies current Good Manufacturing Practice (cGMP) principles and Adaptive Investigative-Site Management (AIM) to site operational performance as data are obtained and offers advantages to clinical studies employing neurocognitive assessments. Objective: To introduce specific advantages of utilizing an SSRO management model with AIM in conjunction with neurocognitive vendor or pharmaceutical sponsor data review. Methods: A neurocognitive preparatory training program is implemented for clinical research coordinators to achieve a thorough understanding of the rationale and methods of the required S ponsor/vendor neurocognitive assessment protocol. An SSRO management service is employed that incorporates AIM, with internal subject matter oversight and quality systems verification. Results: The model will be evaluated for its ability to provide efficient training and certification; high quality data, decreased data variability, decreased time for query resolution and remediation; and alignment of physician expertise to focus solely on patient safety and assessments that require clinician patient knowledge. Conclusion: Extensive internal training reinforced by internal quality systems and on-site neurocognitive expert review prior to submission to neurocognitive vendor or pharmaceutical sponsor may provide superior quality data with expedited external neurocognitive review compared to standard external review alone. Disclosures: Funding for this study was provided by CTMG, Inc. AJ Rissling, D Holland, B Parris, and AL Usala are full-time employees of CTMG Inc. Understanding site and subject preferences in technologies used to increase the reliability of clinical assessments: a multi-national survey Presenters: Lytle D, Cohen E, Rock C, Komorowsky A, Friedmann B Affiliations: Worldwide Clinical Trials, Department of Clinical Assessment Technologies Background: As technology continues to grow, so does its use within the clinical trial industry. In particular, tablet and computer- based eSource/e-clinical outcome assessment (eCOA) solutions are increasingly being used as tools to enhance the reliability of clinical assessments.