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Open Access Methods Development and Modeling Research: Contributions to Advancing TRS and Informing Regulations

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The US Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) funds a wide range of research studies. Methods development and modeling research (MDMR) are 2 areas of interest, as they can help advance tobacco regulatory science (TRS) by fostering data synthesis and exploration of complex relationships. Our analyses of the CTP portfolio found that 13% of publications focused on MDMR, and the most commonly addressed CTP priority research domains were knowledge, attitudes, and behaviors, and toxicity and carcinogenicity. MDMR publications were cited by 1,186 publications, 5 FDA proposed rules and guidance documents, and 3 dockets. MDMR publications are characterized as foundational research and help build the evidence base that informs policy. While MDMR represents a small portion of the CTP research portfolio, they have made important contributions to advancing TRS and informing regulatory actions.

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Document Type: Commentary

Publication date: November 1, 2020

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  • Tobacco Regulatory Science (Electronic ISSN 2333-9748) is a rigorously peer-reviewed online scientific journal for the dissemination of research relevant to the regulation of tobacco products. The journal content includes a broad array of research domains, including chemistry, biology, behavior, community, and population-level surveillance and epidemiology, as well as knowledge syntheses (eg, meta-analyses or state-of-the-art reviews) and analytic modeling. All articles describe the policy relevance of the research outcomes. Given the global nature of tobacco regulation, particularly as a result of international and national policies, Tobacco Regulatory Science publishes high quality research that is relevant to global regulatory needs and requirements. Tobacco Regulatory Science is published electronically 6 times per year.
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