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Theorist's Toy: Equipoise
Debbie is a real patient in crisis. She is poised, with her pen faltering at the end of the consent form, and says, ”You really are telling me that I'll just take the tablets and I won't know and you won't know whether it's the new wonder drug or placebo, and that there is a 1 in 3 chance it's placebo?” The 8 capsules of olaparib or placebo will be hard enough to swallow, but in this moment, she's choking on just how much dedication is required to be a participant in a randomized clinical trial (RCT). Debbie recently died and had quite literally laid down her life early in the pursuit of a greater good.....
....Although we often cite equipoise as the trump card in the overlap between clinical care and scientific research, the ethics of equipoise are complicated and controversial.1 This played out on the front page of The New York Times2 during the development of vemurafenib.3 Equipoise is not the main justification for an RCT being ethical and, in a pure form, rarely exists. Very rarely with the newer treatments can we explain randomization in RCTs with a coin flip of equitable allocation, or the illustration of 2 envelopes; you get to pick, and both contain equally good options (Gore M, personal communication).....
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