From: Reengineering the clinical research enterprise to involve more community clinicians
Patients | Clinicians | Research support organizations (RSOs) | NIH and the biomedical research enterprise |
---|---|---|---|
a) Number, diversity, and representativeness of patients involved with CR | a) Number, diversity, and representativeness of clinicians and settings involved with CR | a) Number of organizations engaged in the support of CR | a) Efficiency of the CR process (e.g., measured as the number of studies completed as planned on schedule) |
b) Safety of patients involved with CR | b) Number of studies and types of studies in which clinicians participate | b) Number of studies and types of studies in which RSOs participate | b) Number of studies being conducted |
c) Retention throughout the tenure of the research study; participation rates in long-term outcome studies | c) Degree of engagement of clinicians with components of CR | c) Degree of engagement of RSOs with components of CR | c) Distribution of study types being conducted |
d) Improved care as a direct consequence of CR participation | d) Efficiency of participation with CR | d) Efficiency of participation with CR | d) Number and proportion of patients who sustain an adverse outcome |
e) Improved care as an indirect effect of CR | e) Clinician bankruptcy as a consequence of involvement with CR | e) RSO dropout from research and financial difficulties following participation in CR | e) Number and proportion of patients who are subjects of Institutional Review Board infractions |
f) Patient satisfaction and trust with CR | f) Clinician satisfaction with CR | f) RSO satisfaction with CR | f) Effect of biomedical research findings on the practice of medicine |
g) Outcomes associated with the conduct of CR | g) Stability of clinician as a participant in CR | g) Stability of RSOs as a participant in CR | g) Effect of biomedical research findings on the health of the people |
 | h) Repeat participation of clinicians in CR |  | h) Long-term CR capabilities |
 |  |  | i) Degree of public trust |