Community equipoise and the architecture of clinical research.

We have argued for a revision of Freedman's concept of clinical equipoise to a broader sense of community that includes physicians and patients. Community equipoise is an essential condition for physicians and patients to answer these questions: Should there be a trial? If so, what kind? We have argued that community equipoise exists because of changes in the knowledge gap between physicians and patients and in the moral justification of medical decision-making. Finally, we have briefly examined the social aspect of medical knowledge to argue that it necessarily includes patients and their values. In effect, community equipoise is not so much an effort to change things, as to explain the way they are. We suggest that patients can participate at a number of points in the process of drug study design and approval: (1) study design with attention to criteria for eligibility, endpoints, and choice of methodology, (2) research review and approval with attention to enhancing community participation in IRB activities, and (3) interim evaluation of ongoing studies with attention to including patient and clinician values in the decisionmaking. Clinical trials are a tool. Like a gun or a bomb or the very drugs they test, they are powerful tools to achieve their ends. The issue is how to properly use such tools as randomization, placebo controls, endpoints, and eligibility. To the extent that community equipoise exists prior to a trial, it means that clinical researchers and patients have collectively addressed the risk and benefit trade-offs that govern the decision to start and to end a clinical trial. In this way, trials can be both valid and valued.