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Clinical equipoise: actual or hypothetical disagreement?
1*Associate Professor, Department of Philosophy and Director, The Ethics Center, Oklahoma State University, 264 Murray Hall Stillwater, OK 74078, USA. scott.gelfand@okstate.edu.
The Journal of Medicine and Philosophy
|July 24, 2013
Summary
Benjamin Freedman's clinical equipoise principle, crucial for randomized clinical trials, is ambiguous. Its best interpretation ironically makes too many trials unethical, mirroring objections to earlier theories.
Area of Science:
- Medical Ethics
- Clinical Research Ethics
Background:
- Benjamin Freedman's 1987 essay proposed clinical equipoise as a fundamental ethical requirement for randomized clinical trials.
- Freedman critiqued Charles Fried's theoretical equipoise for being too fragile and deeming too many trials unethical.
Purpose of the Study:
- To analyze the ambiguity of Freedman's clinical equipoise requirement.
- To demonstrate that the most plausible interpretation of clinical equipoise renders too many randomized clinical trials unethical.
Main Methods:
- Philosophical analysis of ethical principles in clinical research.
- Argumentative essay examining the implications of Freedman's clinical equipoise requirement.
Main Results:
- Freedman's clinical equipoise requirement is open to at least two distinct interpretations.
- The most robust interpretation of clinical equipoise ironically leads to the same ethical concerns Freedman raised against Fried's theory.
Conclusions:
- The ethical foundation for randomized clinical trials, based on Freedman's clinical equipoise, requires re-evaluation.
- Ambiguity in ethical principles can inadvertently restrict valuable clinical research, necessitating clearer guidelines.
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