Open AccessMethods Development and Modeling Research: Contributions to Advancing TRS and Informing Regulations
Author(s) -
Simani Price,
Melanie C Chansky,
Helen I. Meissner,
Martha C. Engstrom,
Tara Dunderdale,
Rachel Grana Mayne,
Ami L. Bahde,
Joy A. Frechtling,
Rachel J Mandal
Publication year - 2020
Publication title -
tobacco regulatory science
Language(s) - English
Resource type - Journals
ISSN - 2333-9748
DOI - 10.18001/trs.6.6.7
Subject(s) - regulatory science , portfolio , food and drug administration , drug development , political science , business , engineering ethics , computer science , medicine , pharmacology , drug , risk analysis (engineering) , engineering , finance , pathology
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.