In an article published this month in the American Journal of Bioethics, FDA Commissioner Robert Califf and coauthors suggest that—despite the potential of embedded pragmatic research to generate information to improve clinical practice and public health policy—it is still relatively uncommon in US healthcare.
“Simply stated, what we are currently doing does not work, and in the face of declining health status we lack answers to critical questions about what we should be doing in health care and public health practice.”
The authors state 3 major obstacles:
- Inadequate data systems: Electronic health records are not designed for research use, and are driven by billing codes and reimbursement structures.
- Data sharing malaise: We have failed to develop a convincing paradigm for sharing individual-level data from routine healthcare delivery
- Current oversight: Research oversight is still not designed to facilitate embedded pragmatic clinical trials or research using real-world evidence.
The authors suggest that achieving a learning health system will require
- More collaboration between health systems and businesses involved in healthcare
- More innovative structures for data sharing across institutions
- Incentives for building the sophisticated infrastructure necessary to enable this work
- Considerations from the bioethics community about how best to foster this research while respecting all those who participate
This article was part of a special issue of the American Journal of Bioethics on pragmatic clinical trials. Members of the Ethics and Regulatory Core contributed the target articles to this issue regarding investigator obligations and the clinician’s duty to participate in embedded research.
On what has surprised him the most – “Patients and clinicians pretty readily grasp the need and the concept. They want to do it. The data part is a lot harder than most people thought. The technology has come a long way; we can do it now. Probably the hardest thing has actually been that the business models for health systems run counter to generating evidence. It’s something that we really haven’t overcome at this point.”