PhenX Tobacco Regulatory Research (TRR) Working Groups (WGs) Roles and Responsibilities
The FDA and the NIH Tobacco Regulatory Science Program (TRSP) are seeking to expand the depth and breadth of tobacco-related measures that can enhance cross-study analysis in large-scale research. Use of the selected consensus measures will facilitate the comparison of results from different studies and the combination of studies to create larger sample sizes, increasing statistical power and the ability to detect more subtle and complex associations. The measures will be housed within the PhenX Toolkit (https://www.phenxtoolkit.org/). PhenX is a repository for measures identified as central in a field, developed with funding from the NHGRI.
A nine-member Tobacco Regulatory Research Panel (TRRP) has been convened to facilitate the inclusion of a core collection and several specialty collections of tobacco regulatory research measures in the Toolkit. Based on a HAVE (Host, Agent, Vector, and Environment) framework, the TRRP has scoped the following Working Groups (WGs):
WG1 – TRR Social/Cognitive
Assess the intrapersonal factors that influence product use, including cognitive, affective, motivational, and perceptive factors, such as risk perceptions, perceived norms, stress, and motivation to quit.
WG2 – TRR Biobehavioral
Assess the descriptive, behavioral, or biological measures that characterize product use, exposure, and potential or actual adverse health outcomes, such as patterns of use, cue reactivity, biomarkers, and genetics.
WG3 – TRR Agent
Assess the tobacco product, such as variety, brand, toxicology, and warning labels.
WG4 – TRR Vector
Assess the industry and retailer activities, such as packaging, advertising, price, and purchase location.
WG5 – TRR Environment
Assess other environmental factors influencing tobacco use, such as Clean Air policies, exposure to anti-tobacco campaigns, and cultural and community factors.
Each WG will be composed of six to eight scientists with relevant expertise. Each WG will have a chair or co-chairs, include two non-voting liaisons from the TRRP, and will be supported by an RTI WG supervisor and manager. It is anticipated that all four WGs will be convened in FY 2014. Each WG will identify up to 12 measures per specialty area using a consensus process to deliver a set of high-priority measures for inclusion in the PhenX Toolkit.
Roles of the WGs