In reality, however, the situation is more complex. Assessments of safety and efficacy often do not move closely in tandem, so that even if smaller, better-targeted clinical trials offer clear evidence of a drug’s efficacy, regulators might demand far larger studies to provide evidence of the drug’s safety.
不过，现实情形要更复杂一些。安全性和疗效的评估通常会平行进行，因此即使小型的、更具针对性的临床试验能提供关于疗效的明确证据，监管者仍可能要求进行更大型的实验以证明药物的安全性。