Central statistical monitoring
Central Statistical Monitoring: A Data-Driven Approach to Quality in Clinical Trials
To address regulatory guidelines regarding a risk-based approach to monitoring, IDDI has designed and developed a new service: Central Statistical Monitoring (CSM), a software solution using advanced statistical tests to determine the quality, accuracy and integrity of clinical trial data, both during and after study conduct. These tests are based on non-predefined (unsupervised) criteria and, as such, are complementary to Key Risk Indicators. IDDI has spun off this technology into a subsidiary company, CluePoints, to commercialize this software solution to the life sciences industry.
Principles of Central Statistical Monitoring:
- Since a common protocol is used in the trial, all participating centers collect data on the same variables for the same visits
- Every variable in the clinical database is potentially indicative of data quality, regardless of its meaning
- Abnormal trends/patterns in the data can be detected by comparing the data across all centers
Central Statistical Monitoring: A Way to Improve the Quality of Clinical Data
“It is clear that systematically incorporating Central Statistical Monitoring (CSM) techniques into the design of a study will lead to tangible benefits and assist sponsors in improving their RBM strategies. By having the capability to identify anomalies in data early, sponsors are provided with the opportunity to address issues as they are uncovered, significantly reducing the risk of regulatory submission failure, while complying with current regulatory guidance and achieving higher quality data at the end of the study. These techniques offer the ability to identify anomalous centers with unusual or suspicious data, while optimizing on-site monitoring and the way in which scarce resources are deployed. Central Statistical Monitoring represents a major step forward for the industry and the future is certainly bright for those sponsors that embrace an objective approach based on all the data, and nothing but the data” Centralized Statistical Monitoring As a Way to Improve the Quality of Clinical Data, Marc Buyse, Mar 24, 2014; Applied Clinical Trials.