Issues in regulating E-cigarette clinical research

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.

• Clinical trials
• electronic cigarettes
• regulation

Declaration of interest

The authors are supported by their employers, the University of Auckland. C. Bullen’s hotel accommodation was paid for by McNeil AB while speaking at one of their seminars on smoking cessation therapies in 2013. He led a study funded by Health NZ Ltd., a research consultancy contracted by Ruyan (a Chinese manufacturer of e-cigarettes), and was principal investigator on the ASCEND trial of e-cigarettes for which all e-cigarettes were supplied at no cost by PGM International, a supplier and retailer of e-cigarettes in the New Zealand market. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.