Ellison G W, Mickey M R, Myers L W
Department of Neurology, UCLA School of Medicine.
Neurology. 1988 Jul;38(7 Suppl 2):73-5.
Data bases describing the natural history of patients with multiple sclerosis or the clinical course of patients treated with placebos might serve as "historical controls" in future clinical therapeutic trials. The results of clinical trials with such controls can be misleading. There is a strong tendency for the new treatment to appear efficacious when historical controls are the comparison group. Therefore, claims of efficacy deduced from trials using such controls should be closely questioned. Thus, such comparison groups probably would be useful for preliminary and early phase II (pilot) trials rather than in more definitive phase III (full) trials.
描述多发性硬化症患者自然病史或接受安慰剂治疗患者临床病程的数据库，可能会在未来的临床治疗试验中作为“历史对照”。使用此类对照的临床试验结果可能会产生误导。当以历史对照作为比较组时，新疗法很容易显得有效。因此，从使用此类对照的试验中推断出的疗效声明应受到严格质疑。所以，此类比较组可能更适用于初步和早期的II期（试点）试验，而非更具决定性的III期（全面）试验。
