Nixon D W
Hollings Cancer Center, Charleston, SC 29425.
Cancer. 1994 Nov 1;74(9 Suppl):2683-6. doi: 10.1002/1097-0142(19941101)74:9+<2683::aid-cncr2820741816>3.0.co;2-q.
The results of early cancer prevention trials now are being reported, and new trials have begun or are being designed. Initial trials used agents such as vitamins and minerals, generally regarded as safe. The trials in progress are using similar agents or macronutrient manipulation, but some have incorporated drugs with low but definite toxic potential, such as tamoxifen. Appropriate prevention trial design requires careful consideration of agent toxicity and the use of such agents in healthy individuals. Full disclosure of risks and benefits to potential subjects is necessary. Other considerations are study duration (usually very long) and subject number (usually very large), both of which increase the cost of a trial. Successful prevention trials must overcome these barriers through innovative design. Possible innovations include the use of intermediate marker end-points, the enrollment of subjects at high risk for a specific cancer, and the use of volunteers to help conduct trials.
早期癌症预防试验的结果正在被报道，并且新的试验已经开始或正在设计中。最初的试验使用了诸如维生素和矿物质等通常被认为是安全的物质。正在进行的试验使用类似的物质或对大量营养素进行调控，但有些试验纳入了具有低但明确毒性潜力的药物，如他莫昔芬。适当的预防试验设计需要仔细考虑物质的毒性以及在健康个体中使用此类物质的情况。向潜在受试者充分披露风险和益处是必要的。其他需要考虑的因素是研究持续时间（通常非常长）和受试者数量（通常非常多），这两者都会增加试验成本。成功的预防试验必须通过创新设计克服这些障碍。可能的创新包括使用中间标志物终点、招募特定癌症高风险的受试者以及利用志愿者协助进行试验。
