The Absence of an Ideal Observer
Why Some Clinical Trials May Not Be What We Think They Are
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According to Richard Firth Green, a major change occurred in our conceptualization of the truth during the reign of Richard II of England in the late 14th century.1 Before then, “trouthe” was an ethical concept that resided within individuals; afterward, truth became an objective reality that existed outside ourselves.1,2 If so, who could be trusted with identifying the truth? Green proposed the “ideal observer”; ie, we can know that “x is better than y” if this judgment were made by an observer who was “fully informed and vividly imaginative, impartial, in a calm frame of mind and otherwise normal.”3 It is interesting to note that Green never claimed that any ideal observers actually existed.
The ideal observer theory is appealing. We believe that investigators can describe an external reality that exists independently of their ethical compasses. We assume that stringent experimental conditions can reveal an unbiased truth. But does the scientific method always yield valid results? Before we answer, we should ask: when we execute a large-scale clinical trial, is there an ideal observer who is impartial, knowledgeable, rational and calm?
A large clinical trial typically involves a leadership committee, a sponsor, numerous geographically dispersed investigators, and a group responsible for operational functions. The leadership committee helps to define the trial hypotheses and the methods by which they are tested; however, its members personally make no observations and may not know exactly how observations are made. The sponsor invests substantial sums of money, without assurance that the hypothesis is valid and …