The Collaboratory’s Ethics and Regulatory Core has recently explored issues around data monitoring in pragmatic clinical trials (PCTs). Important considerations for data monitoring in this context are related to the design, intent, and operational features specific to PCTs. Data Monitoring in Pragmatic Clinical Trials: Points to Consider suggests a set of key areas to evaluate:
- Composition of Data Monitoring Committees
- Use of health systems records data
- Study design and statistical analysis
- Monitoring adherence
- Futility
- Safety
- Efficacy
“Finding ways to describe and disseminate experiences with PCT DMCs should be encouraged in an effort to improve practices and policies.” (Ethics and Regulatory Core)