Kardinal C G
Ochsner CCOP, New Orleans.
J La State Med Soc. 1994 Aug;146(8):359-61.
Prospective randomized trial is the gold standard in clinical research. Randomized trials tend to reduce and even eliminate investigator and patient bias. A poorly-designed or improperly randomized study involving human subjects that will not or cannot answer a scientific question is by definition unethical. However, a well-designed clinical trial is not inherently ethical. Physicians involved in a randomized trial must make the intellectually honest admission that the best therapy for the individual's disease is not yet known. The ultimate protection for human subjects who volunteer to participate in clinical trials is the responsible investigator himself. In patients with advanced cancer there are three primary factors motivating participation: hope that the new treatment will offer a better chance for controlling disease; altruism that even if the treatment did not help them as an individual it might ultimately help others; and trust that the physician would not recommend that the patient enter investigational therapy unless he thought it might be helpful.
前瞻性随机试验是临床研究的金标准。随机试验往往会减少甚至消除研究者和患者的偏倚。一项设计不佳或随机不当的涉及人类受试者的研究，如果无法或不能回答科学问题，从定义上讲就是不道德的。然而，一项设计良好的临床试验本身并不一定合乎道德。参与随机试验的医生必须诚实地承认，针对个体疾病的最佳治疗方法尚不清楚。对自愿参加临床试验的人类受试者的最终保护是负责任的研究者本人。在晚期癌症患者中，有三个主要因素促使他们参与：希望新治疗能提供更好的控制疾病的机会；利他主义，即即使治疗对他们个人没有帮助，但最终可能会帮助其他人；以及信任医生不会建议患者接受试验性治疗，除非他认为这可能会有帮助。
