Issues in regulating E-cigarette clinical research

C. Bullen, O. Knight-West
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引用次数: 2

Abstract

Abstract E-cigarettes have become popular in many countries, despite a lack of long-term safety data and limited clinical evidence for a role in smoking cessation. Indeed, in England, they have overtaken nicotine replacement therapy as a preferred product for cessation support. However, e-cigarettes have reached the market without evaluation of cessation efficacy and safety, bypassing the route required by regulatory authorities for pharmaceuticals that make therapeutic claims. Adequately powered clinical trials that evaluate the cessation efficacy potential of these products compared with current cessation treatments are needed; although the novel features and challenges of assessing this product group, such as wide diversity, rapid evolution and range of user behaviors, do not fit well within the standard clinical trial framework. This should be taken into account by regulators. Alternative designs that are pragmatic, accommodate user preferences, and include smoking reduction end-points may also be required. A more consistent approach to the regulation of products that deliver nicotine—one that does not favor tobacco—should be considered as part of a comprehensive nicotine regulatory model.
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规范电子烟临床研究的问题
尽管缺乏长期的安全性数据和有限的临床证据证明电子烟在戒烟中的作用,但电子烟在许多国家已经流行起来。事实上,在英国,它们已经取代尼古丁替代疗法,成为支持戒烟的首选产品。然而,电子烟在没有对戒烟效果和安全性进行评估的情况下进入市场,绕过了监管机构对做出治疗声明的药品所要求的途径。需要进行充分有力的临床试验,以评估这些产品与当前戒烟治疗相比的戒烟疗效潜力;尽管评估这一产品组的新特点和挑战,如广泛的多样性、快速的演变和用户行为的范围,并不适合标准的临床试验框架。监管机构应该考虑到这一点。可能还需要实用的、适应用户偏好的、包括减少吸烟终点的替代设计。一种更一致的方法来监管含有尼古丁的产品——一种不支持烟草的产品——应该被视为全面尼古丁监管模式的一部分。
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