“非治疗性临床试验”的概念可参考《赫尔辛基宣言》（1996年及之前的版本），即” purely scientific application of medical research, the experimental design is not related to the patient's illness”，如以健康志愿者为受试者的I期以及生物等效性试验。

关于临床获益的判断，根据CIOMS 2016版《International Ethical Guidelines for Health-related Research Involving Humans》Guideline 4 解释：“A study intervention offers a prospect of clinical benefit when previous studies provide credible evidence that the intervention’s potential clinical benefits will outweigh its risks.“早期临床试验没有充分可靠安全性和有效性依据时，被认为是没有预期的直接临床获益的试验。