The use of standard measures and common data elements in the conduct of tobacco regulatory research (TRR) will improve data comparability and facilitate cross-study analyses and replication of findings to inform the regulatory decisions and actions of the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP). This overview paper introduces the PhenX (consensus measures for Phenotypes and eXposures) initiative to identify common measures and common data elements for use in TRR which have been disseminated in the PhenX Toolkit (https://www.phenxtoolkit.org/). It describes the work of the scientific panel that provided guidance to the project and the TRR Core Collection of measures recommended for use by investigators conducting human-subject tobacco regulatory or related tobacco control research. The use of PhenX TRR measures will promote collaborative research and facilitate data interoperability and validation of outcome assessments to inform the FDA CTP’s regulatory activities.
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Collaborators GROUP AUTHORSHIP STATEMENT The following are members of the PhenX Tobacco Regulatory Research Panel (TRRP): Cochairs Gary E Swan, Stanford Prevention Research Center and Judith (Jodi) J Prochaska, Stanford University; TRRP members Neal L Benowitz, University of California, San Francisco, Kevin P Conway, National Institute on Drug Abuse (currently with RTI International), Andrew Hyland, Roswell Park Comprehensive Cancer Center, Robin J Mermelstein, University of Illinois at Chicago, Dana M van Bemmel, US Food and Drug Administration Center for Tobacco Products, Kay L Wanke, National Institutes of Health Office of Disease Prevention and Gordon B Willis, National Cancer Institute; and the PhenX team from RTI International, including Principle Investigator Carol M Hamilton and TRR Project Lead Tabitha Hendershot.
Contributors GES, TPH, DMvB and KLW led the conceptualisation and writing of the manuscript. CMH reviewed the draft and provided substantive content, comments and revisions. The cochairs and members of the TRRP identified the overarching scope of the TRR project, nominated and approved WG experts, identified preliminary measurement constructs for WG consideration, participated in the WGs as liaisons and approved the HAVE Specialty Collections proposed by the WGs. The cochairs and members of the TRRP proposed preliminary measures and voted on final measures included in the PhenX TRR Core Collections. NIH Project Coordinator KLW proposed the PhenX TRR initiative and contributed to its execution and completion. The RTI PhenX team developed, coordinated and facilitated the TRRP and WG process, including project oversight and leadership (TPH, CMH) and project management Darigg C. Brown. PhenX NIH Program Official Erin M Ramos, National Human Genome Research Institute, provided project guidance and funding coordination.
Funding Activities reported in this publication were supported by grant number U41HG007050 from the National Human Genome Research Institute (NHGRI) and U41HG007050-01S1 from the NHGRI and US Food and Drug Administration (FDA) Center for Tobacco Products.
Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the FDA.
Competing interests We have read and understood the Tobacco Control policy on the declaration of interests and declare that we have no competing interests.
Provenance and peer review Not commissioned; internally peer reviewed.
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