This page provides background and links to a series of 12 articles on the ethics and regulatory challenges in pragmatic clinical trials. Each article in the special issue of Clinical Trials describes an issue in detail (e.g., privacy, informed consent) and, where possible, attempts to provide guidance for future pragmatic clinical trials.
The project was supported by the NIH Collaboratory, with additional support from the Patient-Centered Outcomes Research Institute.
- Exploring the ethical and regulatory issues in pragmatic clinical trials
- Gatekeepers for pragmatic clinical trials
- Harmonization and streamlining of research oversight for pragmatic clinical trials
- Oversight on the borderline: quality improvement and pragmatic research
- Harms, benefits, and the nature of interventions in pragmatic clinical trials
- Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials
- Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials
- Use of altered informed consent in pragmatic clinical research
- The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials
- The Food and Drug Administration and pragmatic clinical trials of marketed medical products
- Privacy and confidentiality in pragmatic clinical trials
- Data monitoring committees for pragmatic clinical trials