Suggestions and discussion on protection of vulnerable groups as subjects in clinical trials
临床试验弱势群体作为受试者的保护的建议与探讨

摘要

目的 临床试验中的弱势群体可能会面对更多的风险，因此需要对他们给予更多的关注与保护。方法 通过临床试验现有法规，对弱势受试者加以甄别，并分析该群体的特征及潜在风险，提出相应的保护措施。结果 弱势群体的法规有待完善，临床试验各方也需要对弱势受试者的保护做出更多努力。结论 通过对弱势群体参与临床试验的保障，临床试验的整体质量有望得到进一步提高。

Abstract

Objective Vulnerable groups in clinical trials may face more risks, so they need more attention and protection.
Methods Through the existing regulations on clinical trials, vulnerable subjects are identified, and the characteristics and potential risks of this group are analyzed, and corresponding protection measures are proposed.
Results The regulations on vulnerable groups need to be improved, and all parties involved in clinical trials also need to make more efforts to protect vulnerable subjects.
Conclusion   The overall quality of clinical trials is expected to be further improved by ensuring the participation of vulnerable groups in clinical trials.