Table 3.
Increasing the impact of pragmatic trials
| Domain | Areas for Focused Efforts |
|---|---|
| Operational and technical | Optimizing systems for interacting with clinicians at health care delivery sites, particularly for nonemployee physicians |
| Developing approaches to minimize disruptions to clinical work flow by research activities | |
| Developing strategies for handling complex data extraction, creating systems interoperability, addressing missing data, establishing computable phenotypes, and incorporating documentation tools into electronic medical records | |
| Cultural and philosophical | Elevating interest by health system leaders, clinicians, and patients in incorporating research into the clinical care setting |
| Addressing privacy concerns of providers and patients | |
| Harmonizing varied interpretations of research-related risks | |
| Addressing resistance by institutions to the use of a single IRB of record | |
| Refining approaches to data and safety monitoring | |
| Ethical | Recognizing tradeoffs between improving outcomes for populations and protecting rights of individuals |
| Identifying appropriate “gatekeepers” for access to participants | |
| Clarifying the importance of downstream and indirect effects of research on nonparticipants | |
| Regulatory | Addressing the lack of distinction by the Common Rule between modifying and waiving informed consent |
| Addressing adherence to regulations regarding vulnerable populations | |
| Harmonizing relevant Common Rule and FDA regulations | |
| Clarifying acceptable approaches to use of electronic data for trials under IND and IDE provisions | |
| Clarifying options for safety reporting for trials under IND and IDE provisions | |
| Addressing the requirement for research indicator for Medicare claims | |
| Clarifying distinctions between research and quality improvement | |
| Funding | Increasing collaborations between academic investigators and health systems to identify and maximize opportunities for incorporating trials into health care delivery |
| Educating grant reviewers about unique design or implementation considerations for pragmatic trials |