Harvard School of Public Health, Boston, MA 02115, USA.
Cancer Epidemiol Biomarkers Prev. 2009 Dec;18(12):3196-208. doi: 10.1158/1055-9965.EPI-09-0819.
Methods to assess reduced exposure products should include those that aid in determining likely patterns of human use and exposure. Tobacco industry clinical trial methods may provide insight into strategies to assess potential reduced exposure products (PREP) for public health purposes. Internal tobacco industry documents detailing human clinical research with PREPs were examined to document major research strategies used and identify potentially fruitful methods not currently used in the mainstream arena.
Primary data were obtained from records of research conducted internally by tobacco companies and affiliated researchers, and included manuscript drafts, presentations, protocols, and instruments relating to internal clinical trials of human tobacco use and exposure.
Tobacco industry clinical research has focused on reduced exposure products, most notably Premier, Accord, and Eclipse. The most widely used strategy observed is switching studies, and details of study designs and protocols favored by the industry are described. Key measures include biomarkers of exposure (e.g., cotinine, CO, and specific carcinogens) and acute health effects such as physical health and fitness.
Tobacco industry clinical research has used relatively standard switching study methods, but with a broad set of measures. Clinical switching studies have been conducted by the industry primarily to support existing claims or to develop new claims. Knowledge of prior industry activity can guide and inform future public health research efforts. Although industry clinical trial methods are comparable with current mainstream methods, limited information about the validity of outcome measures used limits their viability for immediate adoption in mainstream science.
评估减害产品的方法应包括那些有助于确定人类使用和暴露模式的方法。烟草业临床试验方法可能为评估潜在减害产品（PREP）用于公共卫生目的的策略提供启示。本文研究了详细描述 PREP 人体临床研究的内部烟草业文件，以记录所使用的主要研究策略，并确定目前在主流领域未使用的潜在有效方法。
主要数据来自烟草公司和附属研究人员内部进行的研究记录，包括与人体烟草使用和暴露的内部临床试验有关的手稿草案、演示文稿、方案和仪器。
烟草业临床研究集中在减害产品上，最著名的是 Premier、Accord 和 Eclipse。观察到使用最广泛的策略是转换研究，并描述了行业青睐的研究设计和方案的细节。关键措施包括暴露生物标志物（如可替宁、CO 和特定致癌物）和急性健康影响，如身体健康和健身。
烟草业临床研究采用了相对标准的转换研究方法，但使用了广泛的措施。行业进行了临床转换研究，主要是为了支持现有主张或开发新主张。了解先前的行业活动可以为未来的公共卫生研究工作提供指导和信息。尽管行业临床试验方法与当前主流方法相当，但关于所使用的结果测量的有效性的有限信息限制了其在主流科学中立即采用的可行性。
