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For what reason are historical controls used in a clinical trial?

  1. When it is more cost-effective

  2. When other controls are not practical or ethical

  3. Only in early-phase trials

  4. When the trial does not involve human subjects

The correct answer is: When other controls are not practical or ethical

Historical controls are used in a clinical trial when other controls, such as a placebo or active control group, are not practical or ethical. This may be due to factors such as the rarity or severity of the condition being studied, or the potential harm that may come to participants in a control group. Using historical controls allows researchers to compare the results of a current study to previous research and can help provide a better understanding of potential outcomes. It is important to note that historical controls should only be used in certain situations and they cannot replace the use of traditional controls in clinical trials involving human subjects. Therefore, options A, C, and D are incorrect because they do not accurately reflect the purpose or proper use of historical controls in a clinical trial.