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PhenX Tobacco Regulatory Research (TRR) Working Groups (WGs) Roles and Responsibilities

Background

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.

Process

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

  • Review well-established scientific measures
  • Propose measures for outreach to the research community
  • Assess feedback from the community outreach process and identify high priority measures for inclusion in the Toolkit
  • Select measures for inclusion in the Toolkit (subject to approval by the TRRP and the PhenX Steering Committee)
  • Recommend individual protocols for collecting and recording PhenX measures

 Process of Review and Selection of Measures and Communication Outreach

  • Identify measures and instruments currently in use in the TRR field
  • Examine the tobacco-related measures in the PhenX Toolkit to ensure that new measures complement existing Toolkit content
  • Assess diversity of methods used for measures and applicability to a range of study designs
  • Use the criteria established for all PhenX WGs to select the measures and protocols
  • Select up to 14 priority measures for community outreach for each WG (10 measures if the WG has two specialty areas)
  • Describe preferred data collection methods for each measure
  • Finalize up to 12 measures and protocols for each WG (8 measures if the WG has two specialty areas) to include in the PhenX Toolkit
  • Identify colleagues and individuals in the research community to review and comment on selected measures via outreach
  • Work with RTI and NIH staff to evaluate input from the scientific community on selected measures and measurement protocols
  • Identify scientific journals and professional meetings/conferences to present and promote use of PhenX measures

WG Member Time Commitment
  • Attend one in-person meeting in the Washington, DC, metropolitan area
  • Participate in conference calls (estimated at one call/month) over a six-month timeframe

Tobacco Regulatory Research Panel
Jodi Prochaska, PhD, MPH (Co-Chair)                        
Stanford University 

Robin Mermelstein, PhD
University of Illinois at Chicago

Gary Swan, PhD (Co-Chair)
Stanford University

Dana van Bemmel, PhD, MPH
Food and Drug Administration 

Neal Benowitz, MD
University of California – San Francisco 

Kay L. Wanke, PhD, MPH
National Institutes of Health 

Kevin Conway, PhD
National Institute on Drug Abuse 

Gordon Willis, PhD
National Cancer Institute 

Andrew Hyland, PhD
Roswell Park Cancer Institute 

 

PhenX TRR Senior Management Team

RTI International

Carol M. Hamilton, PhD
Principal Investigator

Deborah R. Maiese, MPA
Consensus Coordinator 


Tabitha P. Hendershot
Co-Investigator 

Amanda Riley, PMP
Project Manager


Darigg C. Brown, PhD, MPH
TRRP Coordinator

 

National Human Genome Research Institute                     

Erin M. Ramos, PhD, MPH
Project Scientist 

National Institutes of Health, Office of Disease Prevention

Kay L. Wanke, PhD, MPH
Deputy Director, Tobacco Regulatory Science Program

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