Clinical equipoise

Clinical equipoise, also known as the principle of equipoise, provides the ethical basis for medical research involving patients assigned to different treatment arms of a clinical trial. The term was first used by Benjamin Freedman in 1987.^[1]

Ethical concerns during a clinical trial arise in human trials when the investigator(s) begin to believe that one arm of the trial is more beneficial than another. Even if the researcher truly believes in a hypothesis, there is no actual proof that the benefit exists. Once there is sufficient evidence, the research is usually stopped since clinical equipoise is not met.

Clinical equipoise means that there is genuine uncertainty over whether a treatment will be beneficial. This applies also for off-label treatments performed before or during their required clinical trials.

History

Shaw and Chalmers earlier argued that "If the clinician knows, or has good reason to believe, that a new therapy (A) is better than another therapy (B), he cannot participate in a comparative trial of Therapy A versus Therapy B. Ethically, the clinician is obligated to give Therapy A to each new patient with a need for one of these therapies." ^[2] They further stated that any results should be withheld from the researchers during the trial until completion to avoid the ethical dilemma for the researchers and to allow the study to complete.

This method proves to be difficult in modern research, where many clinical trials must be performed and analyzed by experts in that field. Freedman proposed a different approach to this ethical dilemma called clinical equipoise. Clinical equipoise is satisfied "if there is genuine uncertainty within the expert medical community — not necessarily on the part of the individual investigator — about the preferred treatment."^[1] Equipoise allows clinical investigators to continue a trial until they have enough statistical evidence to convince other experts of the validity of their results, without a loss of ethical integrity on the part of the investigators.

Equipoise is also an important consideration in the design of a trial from a patient perspective. This is especially true in randomized controlled trials of surgical interventions where both trial and control arms are likely to have their own associated risks and hoped for benefits. The condition of the patient is also a factor in these risks. Offering patients equipoise is an important part of patient recruitment in this regard; trials where equipoise has not seemed likely have suffered from poor recruitment in the past. ^[3]

References

1. ^ ^{a b} Freedman, B. (1987) 'Equipoise and the ethics of clinical research'. The New England Journal of Medicine, 317, (3):141-145.
2. ^ Shaw, L., A.M. & T. Chalmers, M.D. (1970) 'Ethics in Cooperative Clinical Trials'. Annals of the New York Academy of Sciences, 169, 487-495.
3. ^ R. Lilford et al. 'Trials in surgery', British Journal of Surgery, (2004), 91, 6-16

External links

• Bioethics: An Anthology, pg. 429
• For and against, BMJ 2000;321:756-758