PMI R&D, Philip Morris Products S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.
PMI R&D, Philip Morris Products S.A., Quai Jeanrenaud 5, CH-2000, Neuchâtel, Switzerland.
Regul Toxicol Pharmacol. 2019 Jun;104:115-127. doi: 10.1016/j.yrtph.2019.03.007. Epub 2019 Mar 14.
Offering safer alternatives to cigarettes, such as e-cigarettes and heated tobacco products, to smokers who are not willing to quit could reduce the harm caused by smoking. Extensive and rigorous scientific studies are conducted to assess the relative risk of such potentially modified risk tobacco products compared with that of smoking cigarettes. In addition to the peer review of publications reporting individual studies, we aimed to gauge the plausibility of the evidence to the scientific community and appreciate likely necessary additions prior to regulatory submission. Therefore, we sponsored a two-tier peer review organized by an independent third party who identified, recruited, and managed 7 panels of 5-12 experts whose identity remains unknown to us. The reviewers had access to all publications and raw data from preclinical and clinical studies via a web portal. The reviewers were asked questions regarding study design, methods, quality of data, and interpretation of results to judge the validity of the conclusions regarding the relative effects of the Tobacco Heating System 2.2 compared with cigarettes. Once their conclusions were submitted, the experts had the opportunity to participate in an anonymized online debate with their fellow panel members. We present here the results obtained from this innovative peer review effort which revealed supportive or very supportive of the study methods and results, and support the robustness of the studies and validity of the conclusions.
向不愿意戒烟的吸烟者提供更安全的替代香烟的产品，如电子烟和加热烟草产品，可以减少吸烟造成的危害。广泛而严格的科学研究旨在评估此类潜在改良风险烟草产品与吸烟相比的相对风险。除了对报告个别研究的出版物进行同行评审外，我们还旨在向科学界评估证据的合理性，并在提交监管部门之前评估可能需要增加的内容。因此，我们赞助了由独立第三方组织的两级同行评审，该评审确定、招募并管理了由 5 至 12 名专家组成的 7 个小组，我们并不知道他们的身份。评审员可以通过一个网络门户访问所有来自临床前和临床研究的出版物和原始数据。评审员被要求就研究设计、方法、数据质量和结果解释提出问题，以判断关于与香烟相比，Tobacco Heating System 2.2 的相对效果的结论的有效性。一旦提交了他们的结论，专家们就有机会与他们的小组成员进行匿名在线辩论。我们在此介绍从这项创新的同行评审工作中获得的结果，该结果表明支持或非常支持研究方法和结果，并支持研究的稳健性和结论的有效性。
