Abdoler Emily, Taylor Holly, Wendler David
Department of Bioethics, NIH Clinical Center, Bethesda Maryland, USA.
Clin Cancer Res. 2008 Jun 15;14(12):3692-7. doi: 10.1158/1078-0432.CCR-08-0876.
Recent guidance from the Food and Drug Administration supports the conduct of a new type of exploratory clinical trial, commonly called phase 0 clinical trials. Proponents argue that phase 0 clinical trials have the potential to expedite the development of new oncology drugs while exposing fewer research subjects to the risks of experimental treatments. At the same time, phase 0 oncology trials raise important ethical concerns that have received little attention. In particular, there is a question of whether it is ethical to enroll individuals in research that offers them no potential for clinical benefit. Further concern focuses on the inclusion of terminally ill and consequently vulnerable cancer patients in these trials. To evaluate these concerns, this article considers relevant empirical data from phase 1 oncology trials and develops several recommendations regarding the conduct of phase 0 clinical trials in oncology.
美国食品药品监督管理局最近发布的指南支持开展一种新型的探索性临床试验，通常称为0期临床试验。其支持者认为，0期临床试验有潜力加快新型肿瘤药物的研发，同时让更少的研究对象承受实验性治疗的风险。与此同时，0期肿瘤试验引发了一些重要的伦理问题，但这些问题几乎没有受到关注。特别是，让那些没有临床获益可能性的个体参与研究是否符合伦理，这是个问题。进一步的担忧集中在将晚期绝症且因此处于弱势的癌症患者纳入这些试验。为了评估这些担忧，本文考量了1期肿瘤试验的相关实证数据，并就肿瘤学0期临床试验的开展提出了若干建议。
