Innovations In Clinical Neuroscience

CNS Summit 2016

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

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[ V O L U M E 1 4 , N U M B E R 1 – 2 , J A N U A R Y – F E B R U A R Y 2 0 1 7 , S U P P L E M E N T ] Innovations in CLINICAL NEUROSCIENCE S21 with stable schizophrenia or schizoaffective disorder at two clinical research sites during the period from 2009 to 2014. The a nalysis showed that shortening the length of the inpatient period, increasing the outpatient period, and shortening the longest period between outpatient visits had a positive impact on completion. A c riticism of the previous analysis is that it did not include the impact of the subject stipend. Here, we reanalyzed the dataset with the addition of the following variables: the stipend for an inpatient day, the stipend for an outpatient visit, and total stipend divided by the number of days in the study. Stipends are adjusted for inflation using the Consumer Price Index. Results: The predictive strength of each trial design and stipend variable on subject study completion was presented. Conclusion: Conclusions were drawn that inform study design for better subject retention. Disclosures/funding: None reported. Toward a better understanding of informant contributions to schizophrenia trial quality: data from the encenicline cognitive impairment program Presenters: Nations K 1 , Rosenthal A 1 , Spiridonescu L 1 , Truskowski L 1 , Quintanilla A 1 , Prilliman C 1 , Wise-Rankovic A 1 , Gibertini M 1 , Keefe R 2 , Walker T 2 , Brannan S 3 , Hilt D 3 Affiliations: 1 INC Research, 2 NeuroCog Trials, 3 FORUM Pharmaceuticals Objective: Schizophrenia protocols require eligible subjects to bring a reliable informant to confirm symptomatic history. Definitions of "reliable" typically depend on clinical intuition. The current analysis examined informant characteristics as predictors of subject/trial quality in two cognitive impairment in schizophrenia (CIS) Phase 3 trials evaluating encenicline versus placebo. Design: EVP-6124-015/016 were randomized, double-blind trials (N=1,520). Neither showed a treatment effect on co- primary endpoints, the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB), and the Schizophrenia Cognition Rating Scale (SCoRS), a measure that includes informant report. A "consistent informant" was required for trial entry and was defined as a person who interacts with the subject at least twice weekly and who could attend site visits. The contract r esearch organization (CRO) medical/clinical team collected data on four informant variables: 1) relationship to subject, 2) duration of relationship, 3) frequency of contact, and 4) weekly time w ith subject. We examined these factors as predictors of subject quality markers: trial completion, drug adherence, and non- response to placebo on key endpoints. Results: Frequency of contact between the subjects and their informants significantly predicted trial completion (2=20.01, p<0.001). This quality marker was further supported by an important interaction between treatment group and frequency of contact on the MCCB CFB [F(4,1304)=2.08, p=0.08], showing that subjects in the 2mg group, but not in the placebo or 1mg groups living with their informant were more improved at endpoint than subjects with daily contact. Conclusion: These data may serve as a source for appropriate and operationally feasible definitions of informant reliability in future CIS protocols. Informant factors are further examined for regional differences and their influence on MCCB/SCoRS relationships. Disclosures/funding: Funding was provided by FORUM Pharmaceuticals, Waltham, Massachusetts. INC Research, Raleigh, North Carolina, was the CRO responsible for execution of both trials. KN, ASR, LS, LT, AQ, CP, AWR, and MG are employees of INC Research. SB and DH were employees of FORUM at the time of this research. RK is an owner of NeuroCog Trials, Durham, North Carolina, and TW is an employee of NeuroCog Trials. Understanding rater preferences in services used to increase the reliability of clinical trials: a multi-national survey Presenters: Komorowsky A 1 , DiCindio L 1 , Rock R 1 , Lobb J 1 , Avrumson R 1 , Carbo M 1 , Baldwin K 1 , Rohleder L 1 , Lytle D 1 ; Murphy M 1 Affiliations: 1 Worldwide Clinical Trials, King of Prussia, Pennsylvania Objective: Industry literature supports the use of independent, expert clinicians to train and monitor data quality for psychiatric/neurological assessments in order to reduce bias and variability in outcomes data. As the number of clinical trials continues to increase, so does the f requency with which site raters undergo training and monitoring using different modalities and standards. The authors investigated raters' perceptions and preferences with common rater training a nd data surveillance programs as well as the potential impact of rater engagement on data quality. Methods: A nonprobability-based, purposive survey was employed in which site staff engaged in interventional psychiatry/neurology studies was contacted from the Worldwide Clinical Trials database of site raters and coordinators. Over 2,000 surveys were deployed using a proprietary survey engine. Results: Reponses from the survey revealed key rater preferences in methods of training and surveillance. Specific preferences were found for training via video demonstration with a practice quiz as well as preferences for in-person investigators' meetings. Data surveillance preferences were found for some methodologies, including source document review. The survey also identified pre-conceived perceptions of the raters regarding the purpose of rater training and surveillance. Conclusion: Understanding site rater preferences is paramount to enriching the current rater training and data monitoring methods, which can directly impact study outcomes. Implications for training and quality assurance methodology were also outlined. Disclosures/funding: All authors are full-time employees of Worldwide Clinical Trials, King of Prussia, Pennsylvania, and have no conflicts of interest.

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