Clinical Trial Method for Assessing a Tobacco Product

2009年6月通过的《家庭吸烟预防和烟草控制法案》授权食品 和药品管理局对烟草产品进行监管。在FSPTC中，有很大的重点是烟草 产品及其评价。该产品评估过程的一个关键组成部分是人体临床 审判。这些试验将告知监管机构对产品的吸收情况，产品是如何 使用情况、接触毒物的程度以及与这种使用模式相关的可能的健康风险。到目前为止， 还没有研究检验最佳的实验方法来提供必要的信息 关于烟草产品(例如，经修改的风险烟草产品)或任何 对烟草产品实施的法规(例如，性能标准)确保不会对公众造成损害 基于这一决定的结果。这项研究项目的目标是测试一种临床试验方法 评估烟草产品，并解决一些方法上的差距，以便提供指导 向FDA和其他国际监管机构提交评估的最佳措施和方法 烟草产品的价格。这项试验是一项受试者之间的平行臂设计，受试者被随机分为 五种实验条件之一，有不同的教学设置，为期12周。这个 被选中进行检测的产品是一种口服烟草产品。骆驼鼻。教学内容包括：完整 随意使用对香烟的替代与部分替代与鼻烟使用的具体说明。一个 持续吸烟者的对照组也将被包括在设计中。主要结果衡量标准 包括毒物暴露和影响的生物标志物以及对产品的主观反应。整体而言 本P01的目标是吸收本项目的结果与其他P01项目的结果，以 确定研究结果的一致性、措施的预测性有效性，并确定 建议的“上市前”研究可以用来确定引入烟草产品的风险和好处。 进入市场。

The passage of the Family Smoking Prevention and Tobacco Control Act in June 2009 empowers the Food and Drug Administration to regulate tobacco products. In the FSPTC, there is significant focus on tobacco products and its evaluation. One critical component of this product evaluation process is human clinical trials. These trials will inform the regulatory agency about the uptake of the product, how the product is used, the extent of toxicant exposure and possible health risk associated with this pattern of use. To date, no study has examined the best experimental methods to provide the information that is necessary to make a sound scientifically-based decision about a tobacco product (e.g., modified risk tobacco products) or any regulations imposed on tobacco products (e.g., performance standards) that assures no public harm will result based on this decision. The goals of this research project are to test a clinical trial method for assessing tobacco products and also address some methodological gaps so that guidance can be provided to the FDA and other international regulatory agencies on the best measures and methods for the evaluation of tobacco products. This trial is a between-subject, parallel-arm design in which subjects are randomized to one of the five experimental conditions, with different instructional sets, for a period of 12-weeks. The product chosen for testing is an oral tobacco product. Camel Snus. The instructional sets include: complete substitution vs. partial substitution for cigarettes by ad libitum use vs. specific instruction for snus use. A control group of continuing smokers will also be included in the design. The primary outcome measures include biomarkers of toxicant exposure and effect and subjective responses to the product. The overall goal for this P01 is to assimilate the results from this Project with the results from the other P01 Projects to determine consistency of findings across studies, predicitive validity of measures, and to determine if the proposed "pre-market" studies can be used to determine risks and benefits of introducing a tobacco product into the market.