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 …

根据理查德·菲斯·格林（Richard Firth Green）的说法，在14世纪后期，英国理查德二世统治期间，我们对真理的概念化发生了重大变化。¹在此之前，“麻烦”是一个存在于个人内部的道德概念；此后，真理成为我们外部存在的客观现实。^1，2如果是这样，谁可以与识别真相被信任？格林提出了“理想的观察者”；也就是说，如果观察者做出了这样的判断，我们“ x比y更好”，那么观察者将“充分地了解并生动地想像，公正，以平静的心态或其他正常的态度”。³ 有趣的是，格林从未声称实际上存在过任何理想的观察者。

理想的观察者理论很有吸引力。我们相信，调查人员可以描述独立于其道德准则而存在的外部现实。我们假设严格的实验条件可以揭示一个公正的事实。但是科学方法是否总是能产生有效的结果？在回答之前，我们应该问：在进行大规模的临床试验时，是否有一个理想的观察员，该观察员是公正，知识渊博，理性而冷静的？

大型临床试验通常包括领导委员会，发起人，众多地域分散的研究人员以及负责运营职能的小组。领导委员会帮助定义试验假设及其检验方法；但是，其成员本人不发表任何意见，并且可能不确切知道如何进行观察。发起人投入了大量资金，无法保证该假设是正确的，并且…