国外药品临床试验中的伦理学现状及思考

药品临床试验为保障受试者的权益 ,必须考虑到医学伦理学问题。赫尔辛基宣言是受试者的一种保护性精神特质。参与临床试验病人的权益意识已增强 ,但宣言所规定的权利范围尚有不足之处 ,且某些方面还存在模棱两可的解释。从伦理学角度看 ,安慰剂对照还存在争议。FDA认为安慰剂对照属于“金标准”,但尚无合理科学依据。循证医学的兴起及其强调证据的可靠性对药品临床试验提出更高的要求 ,同时这种要求却触及了相关的伦理学问题。对以上问题进行讨论和分析 ,有助于管理者从伦理学角度管理好药品临床试验

Development and problems of medical ethics in foreign clinical drug trials

Medical ethics must be considered for protecti ng the rights and inte rests of patients in clinical trials. The Declaration of Helsinki has a predomin ant protectionist ethics towards the community and individuals approached to par ticipate in research. Now the subjects have enhanced the level of the rights and interests, but limits of some rights in the declaration are devoid of systemati cness and have ambiguous explanation. The use of placebo controls in clinical tr ials of drugs proved to be an unusually vexing problem. FDA officials consider placebo controls the “gold standard”, nevertheless placebo controls are short of scientific evidence. It is Evidence-based Medicine (EBM) and emphasis of ev idence who need the high-quality clinical trials, yet it violates the principle of ethics in some degree. It will be helpful for the administrators to supervis e the clinical experiments on drugs well from the point of ethical views.