Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders

Innovations in Clinical Neuroscience

the CNS SUMMIT DATA QUALITY MONITORING WORKGROUP CORE MEMBERS—David Daniel,MD ; Amir Kalali,MD ; Mark West ; David Walling,PhD ; Dana Hilt,MD ; Nina Engelhardt,PhD ; Larry Alphs,MD,PhD ; Antony Loebel,MD ; Kim Vanover,PhD ; Sarah Atkinson,MD ; Mark Opler,PhD,MPH ; Gary Sachs,MD ; Kari Nations,PhD ; and Chris Brady,PsyD

关键词: Data quality, clinical trials, clinical trial methodology, data monitoring, CNS, trial design, drug development;   

学科分类：精神健康和精神病学

来源: Matrix Medical Communications, LLC

【 摘 要 】

This paper summarizes the results of the CNS Summit Data Quality Monitoring Workgroup analysis of current data quality monitoring techniques used in central nervous system (CNS) clinical trials. Based on audience polls conducted at the CNS Summit 2014, the panel determined that current techniques used to monitor data and quality in clinical trials are broad, uncontrolled, and lack independent verification. The majority of those polled endorse the value of monitoring data. Case examples of current data quality methodology are presented and discussed. Perspectives of pharmaceutical companies and trial sites regarding data quality monitoring are presented. Potential future developments in CNS data quality monitoring are described. Increased utilization of biomarkers as objective outcomes and for patient selection is considered to be the most impactful development in data quality monitoring over the next 10 years. Additional future outcome measures and patient selection approaches are discussed.

【 授权许可】

Unknown