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Table 2 Potential measures for evaluating the success or failure of a reengineered research enterprise relative to its major stakeholders

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