Cancer Prev Res (Phila). 2012 Feb;5(2):179-88. doi: 10.1158/1940-6207.CAPR-11-0572.
Prevention trials of whole foods or simple extracts offer prospects for reducing an expanding global burden of cancer effectively, and in contrast to promising isolated phytochemicals or pharmaceuticals, frugally. We use the term "green" chemoprevention to differentiate a food-centered approach that is sustainable in underserved populations. It can be applied to personalized medicine just as well as a pharmaceutical approach, but only green chemoprevention can be applied in both rich and poor settings. This MiniReview discusses some of the challenges of conducting food-based trials in developing countries, with particular emphasis on moving the limited number of promising phase II trials forward as placebo-controlled randomized trials, the gold standard for prevention studies. How does one define a placebo for a food? What is the regulatory context of such a food-based product? How can such products be produced and standardized to the benefit of a larger, individual trial, and importantly, the research community at large? What are the challenges and opportunities of conducting such trials in the international setting? Finally, how does one make the science practical?
预防试验整体食品或简单提取物提供了前景,有效地减少日益扩大的全球癌症负担,并且与有希望的孤立植物化学物质或药物相比,成本低廉。我们使用“绿色”化学预防这个术语来区分以食物为中心的方法,这种方法在服务不足的人群中是可持续的。它既可以应用于个性化医学,也可以应用于药物方法,但只有绿色化学预防可以在富人和穷人环境中应用。这篇综述讨论了在发展中国家进行基于食物的试验所面临的一些挑战,特别强调将有限数量的有前途的 II 期试验推进为安慰剂对照随机试验,这是预防研究的金标准。如何为一种食物定义安慰剂?这种基于食物的产品的监管环境是什么?如何生产和标准化这些产品,使更大的个体试验受益,更重要的是,使整个研究界受益?在国际环境中进行此类试验的挑战和机遇是什么?最后,如何使科学实用化?