ObjectiveTo critically assess the methodological characteristics and quality of interventional clinical trials investigating the effects of heated tobacco products (HTPs).Data sourcesWeb of Science (Core collection and MEDLINE), Scopus, MedRxiv, ClinicalTrials.gov and ICTRP trial databases and transnational HTP manufacturer online publication libraries were searched for clinical trials on HTPs published between January 2010 and April 2022.Study selectionInterventional clinical trials of any design, in which at least one group of adult participants used a currently marketed HTP, were selected by two reviewers with good or very good agreement.Data extractionData relating to trial characteristics and effects of intervention on primary outcomes were extracted using a predesigned form. Risk of bias was assessed using Cochrane’s Risk of Bias tool v1.Data synthesis40 trials were included, 29 of which were tobacco industry affiliated. Methodological characteristics, such as registration, design, setting, comparator interventions, participants, outcomes and analyses, varied between trials, though there were few significant differences between industry-affiliated and independent trials. Of the 40 trials, 33 were judged to be at high risk of bias and 6 at unclear risk of bias. Trial findings were not significantly associated with either affiliation or risk of bias.ConclusionsThe conduct and reporting of HTP interventional clinical trials were poor in many respects and limited to investigating effects of short-term exposure. These trials fall short of what is needed to determine whether HTPs are beneficial to public health, meaning they may not be a sound basis for tobacco control policy decisions.

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Background Unhealthy commodities are major drivers of the global burden of noncommunicable diseases. Commercial actors attempt to influence policy to undermine regulation and existing literature draws attention to the underlying macro-level factors that enable this influence. Public health literature also suggests that industry adapts to regulation and such influence may thus be considered a complex adaptive system. Therefore, this study aimed to build a qualitative systems map to help communicate the complexity of industry influence and develop a tool to facilitate the identification of interventions in follow up research. Methods In-person group model grouping workshops were adapted for the online environment. A preliminary qualitative systems map was developed by synthesising two recent studies to facilitate workshop discussions and expedite the mapping process. Twenty-three small group system mapping workshops were conducted with a total of 52 stakeholders, representing researchers, civil society, and public officials from various geographical regions. Results The qualitative systems map identifies five pathways through which industry influences policy: a) direct access to public sector decisionmakers; b) creation of confusion and doubt about policy decisions; c) prioritisation of commercial growth; d) industry leveraging the legal and dispute settlement processes; and e) industry leveraging policymaking rules and processes. The pathways contribute to perpetuating macro-level factors that enable industry to deploy practices to influence policy. Conclusions A system thinking approach can be applied to industry influence on health policy to depict a complex adaptive system. Interventions need to take into consideration the system's complexity and adaptivity. Further research is needed to test, and improve the systems map and identify interventions to achieve systems change.