In some PCTs with very ill populations, serious adverse events (SAEs) such as death may be expected outcomes. As in a traditional RCT with such a population, monitoring of individual SAEs is not likely to be helpful; however, monitoring comparative rates of SAEs between treatment arms can help to ensure that the study intervention is not causing more SAEs.
- Which PCTs Should Have a DMC?
- Monitoring Protocol Adherence
- Data Issues With Monitoring PCTs
- Monitoring for Serious Adverse Events
- Futility Assessment
- Case Study: Planning for Monitoring PCTs
- Role of Stakeholder Perspectives
- Special Training and Resources for DMCs of Pragmatic Trials
- Additional Resources