Clinical trials methods for evaluation of potential reduced exposure products.
Clinical trials methods for evaluation of potential reduced exposure products.
复制标题
DOI：
10.1158/1055-9965.epi-09-0654
复制
发表时间：
2009-12
期刊：
影响因子：
--
通讯作者：
Shields PG
中科院分区：
文献类型：
--
作者：
Hatsukami DK;Hanson K;Briggs A;Parascandola M;Genkinger JM;O'Connor R;Shields PG
潜在的减少暴露烟草制品（PREP）可能有希望减少与烟草有关的发病率或死亡率，或可能对个人或人群造成更大的伤害。确定这些产品的风险或获益的关键是有效的人体临床试验PREP评估方法。评估涉及确定这些产品对暴露和效应生物标志物的影响，这些生物标志物可作为危害的替代物，并评估消费者摄入和滥用产品的可能性。本文提出了与PREP评估相关的关键方法学问题，回顾了用于评估PREP的方法，并描述了这些方法的优势和局限性。此外，建议临床试验PREP评估方法和未来的研究方向在这方面的基础上，这一审查和国家癌症研究所主办的临床试验PREP方法研讨会的审议提供。
Potential reduced exposure tobacco products (PREPs) may have promise in reducing tobacco-related morbidity or mortality or may promote greater harm to individuals or the population. Critical to determining the risks or benefits from these products are valid human clinical trial PREP assessment methods. Assessment involves determining the effects of these products on biomarkers of exposure and of effect, which serve as proxies for harm, and assessing the potential for consumer uptake and abuse of the product. This article raises the critical methodological issues associated with PREP assessment, reviews the methods that have been used to assess PREPs, and describes the strengths and limitations of these methods. Additionally, recommendations for clinical trials PREP assessment methods and future research directions in this area based on this review and on the deliberations from a National Cancer Institute sponsored Clinical Trials PREP Methods Workshop are provided.