The current paper describes the PhenX (Phenotypes and eXposures) Toolkit Tobacco Regulatory Research Agent specialty area and the Agent Working Group’s (WG’s) 6-month consensus process to identify high-priority, scientifically supported measures for cross-study comparison and analysis. Eleven measures were selected for inclusion in the Toolkit. Eight of these are interviewer-administered or self-administered protocols: history of switching to lower tar and nicotine cigarettes, passive exposures to tobacco products, tobacco brand and variety (covering cigars, cigarettes and smokeless tobacco separately), tobacco product adulteration (vent-blocking or filter-blocking) and tobacco warning label exposure and recall. The remaining three protocols are either laboratory-based or visual inspection-based: measurement of nicotine content in smoked or smokeless tobacco products and the physical properties of these two classes of products. Supplemental protocols include a biomarker of exposure and smoking topography. The WG identified the lack of standard measurement protocols to assess subjective ratings of tobacco product flavours and their appeal to consumers as a major gap. As the characteristics of tobacco products that influence perception and use are tobacco regulatory research priorities, the reliable assessment of flavours remains an area requiring further development.
- packaging and labelling
- non-cigarette tobacco products
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Collaborators The following are members of the PhenX TRR Agent WG: Co-Chairs Richard J O’Connor, Roswell Park Comprehensive Cancer Center, and Clifford H Watson, CDC; WG members Marielle C Brinkman, Battelle Memorial Institute, Barry G Green, John B Pierce Laboratory, David Hammond, University of Waterloo, James F Pankow, Portland State University and Irina Stepanov, University of Minnesota; TRRP Liaisons Neal L Benowitz, University of California, San Francisco; NIH Project Coordinator Kay L Wanke, NIH Office of Disease Prevention; NIH Liaison Kevin M Walton, National Institute on Drug Abuse and the PhenX team from RTI International, including Tabitha Hendershot, TRR Project Lead, Destiny Nettles, WG Supervisor and Rebecca Geisler, WG Manager.
Contributors GES, TPH and KLW led the conceptualisation of the manuscript and the coordination of the writing team. RJO and GES drafted the scientific content of the manuscript, and TPH, DSN and RG drafted the Methods and Results sections of the manuscript. CHW, GES, TPH and KLW reviewed the draft and provided substantive revisions. The Co-Chairs and Members of the PhenX TRR Agent WG identified and proposed preliminary measures and voted on final measures included in the PhenX TRR Agent Specialty Collection. TRRP members NLB and Dana M van Bemmel, FDA Center for Tobacco Products (CTP), ensured that the WG process maintained fidelity with overall project goals. Federal Agency Liaisons Tricia Johnson, FDA CTP, and KMW ensured project consistency with agency goals and priorities. NIH Project Coordinator KLW proposed the PhenX TRR initiative and contributed to its execution and completion. The PhenX team coordinated and facilitated the WG process, including project oversight and leadership (TPH), supervisory management (DSN) and project management (RG). PhenX NIH Program Official Erin M Ramos, National Human Genome Research Institute (NHGRI), provided project guidance and funding coordination. Carol M Hamilton, RTI International, is the PhenX Principal Investigator and provided project guidance and supervision.
Funding Research reported in this publication was supported by grant numbers U41HG007050 and U41HG007050-01S1 from the NIH NHGRI and FDA CTP.
Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH, the CDC or the FDA.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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