Impact of National Institutes of Health and Food and Drug Administration Tobacco Research Funding: A Bibliometrics Analyses.

INTRODUCTION: Conduct bibliometric analyses documenting the output of National Institutes of Health (NIH) tobacco-related and Food and Drug Administration (FDA) tobacco regulatory science (FDA-TRS) research portfolios. AIMS AND METHODS: PubMed identifiers for publications between 2015 and 2020 citing tobacco funding by NIH and/or FDA were imported into NIH iCite generating measures of productivity and influence, including number of citations, journal, relative citation ratios (RCR), and comparison of research influence across Web of Science (WoS) disciplines. Coauthorship and measures of centrality among and between NIH and FDA-supported investigators gauged collaboration. RESULTS: Between FY 2015 and 2020, 8160 publications cited funding from NIH tobacco-related grants, 1776 cited FDA-TRS grants and 496 cited Common funding (ie, both NIH and FDA-TRS funding). The proportion of publications citing NIH grants declined while those citing FDA-TRS or Common funding rose significantly. Publications citing Common funding showed the highest influence (mean RCR = 2.52). Publications citing FDA-TRS funding displayed higher median RCRs than publications citing NIH funding in most WoS categories. Higher translational progress was estimated over time for FDA-TRS and Common publications compared to NIH publications. Authors citing Common funding scored highest across all collaboration measures. CONCLUSIONS: This study demonstrates the high bibliometric output of tobacco research overall. The rise in publications citing FDA-TRS and Common likely reflects increased funding for TRS research. Higher RCRs across WoS subject categories and trends towards human translation among FDA-TRS and Common publications indicate focus on research to inform regulation. This analysis suggests that FDA support for TRS has expanded the field of tobacco control resulting in sustained productivity, influence, and collaboration. IMPLICATIONS: This paper is the first effort to better describe the impact of tobacco research resulting from the addition of FDA funding for TRS in the past decade. The analysis provides impetus for further investigation into the publication topics and their focus which would offer insight into the specific evidence generated on tobacco control and regulation.

NIH Primary and Secondary Prevention Research in Humans: a Portfolio Analysis of Study Designs Used in 2012-2019.

We can learn a great deal about the research questions being addressed in a field by examining the study designs used in that field. This manuscript examines the research questions being addressed in prevention research by characterizing the distribution and trends of study designs included in primary and secondary prevention research supported by the National Institutes of Health through grants and cooperative agreements, together with the types of prevention research, populations, rationales, exposures, and outcomes associated with each type of design. The Office of Disease Prevention developed a taxonomy to classify new extramural NIH-funded research projects and created a database with a representative sample of 14,523 research projects for fiscal years 2012-2019. The data were weighted to represent the entirety of the extramural research portfolio. Leveraging this dataset, the Office of Disease Prevention characterized the study designs proposed in NIH-funded primary and secondary prevention research applications. The most common study designs proposed in new NIH-supported prevention research applications during FY12-19 were observational designs (63.3%, 95% CI 61.5%-65.0%), analysis of existing data (44.5%, 95% CI: 42.7-46.3), methods research (23.9%, 95% CI: 22.3-25.6), and randomized interventions (17.2%, 95% CI: 16.1%-18.4%). Observational study designs dominated primary prevention research, while intervention designs were more common in secondary prevention research. Observational designs were more common for exposures that would be difficult to manipulate (e.g., genetics, chemical toxin, and infectious disease (not pneumonia/influenza or HIV/AIDS)), while intervention designs were more common for exposures that would be easier to manipulate (e.g., education/counseling, medication/device, diet/nutrition, and healthcare delivery). Intervention designs were not common for outcomes that are rare or have a long latency (e.g., cancer, neurological disease, Alzheimer's disease) and more common for outcomes that are more common or where effects would be expected earlier (e.g., healthcare delivery, health related quality of life, substance use, and medication/device). Observational designs and analyses of existing data dominated, suggesting that much of the prevention research funded by NIH continues to focus on questions of association and on questions of identification of risk and protective factors. Randomized and non-randomized intervention designs were included far less often, suggesting that a much smaller fraction of the NIH prevention research portfolio is focused on questions of whether interventions can be used to modify risk or protective factors or to change some other health-related biomedical or behavioral outcome. The much heavier focus on observational studies is surprising given how much we know already about the leading risk factors for death and disability in the USA, because those risk factors account for 74% of the county-level mortality in the USA, and because they play such a vital role in the development of clinical and public health guidelines, whose developers often weigh results from randomized trials much more heavily than results from observational studies. Improvements in death and disability nationwide are more likely to derive from guidelines based on intervention research to address the leading risk factors than from additional observational studies.

NIH Tobacco Research and the Emergence of Tobacco Regulatory Science.

INTRODUCTION: This study explores how the emergence of FDA-funded Tobacco Regulatory Science (TRS) research complements and perhaps influenced the direction of tobacco research supported by NIH. AIMS AND METHODS: New NIH- and FDA-funded tobacco projects awarded in fiscal years (FY) 2011-2020 were identified using internal NIH databases of awarded grants. Project abstracts and research aims were coded by the authors to characterize research domains and tobacco products studied. RESULTS: Between FY 2011 and 2020, NIH funded 1032 and FDA funded 322 new tobacco projects. For the years and grant activity codes studied, the number of new NIH tobacco projects declined while FDA's increased; combined the number of new projects held steady. Much of NIH research included smoking combustibles (43.7%). The most common products in FDA research were cigarettes (74.8%) and e-cigarettes/ENDS (48.1%). Most NIH (58.6%) and FDA (67.7%) projects included research on the determinants of tobacco use. Another area of apparent overlap was health effects (29.5% NIH and 30.1% FDA). Projects unique to NIH included treatment interventions (33.3%), disease pathology/progression (17.8%) and neurobiology (18.9%). A minority of both NIH and FDA projects included populations particularly vulnerable to tobacco product use. CONCLUSIONS: In total, support for new tobacco research supported by NIH and FDA combined remained steady for the time period covered, though there was a concomitant decline in NIH tobacco projects with the increase in FDA-funded TRS projects for the activity codes studied. Despite the apparent overlap in some areas, both NIH and FDA support research that is unique to their respective missions. IMPLICATIONS: NIH continues to support tobacco research that falls within and outside of FDA's regulatory authorities. This research still is needed not only to bolster the evidence base for regulatory decisions at the national and state levels, but also to advance a comprehensive scientific agenda that can inform multiple levels of influence on tobacco control, use and addiction. It will be important to continue monitoring FDA-funded TRS and NIH-funded tobacco research portfolios to ensure that the level of support for and focus of the research is sufficient to address the burden of tobacco-related morbidity and mortality.

New NIH Primary and Secondary Prevention Research During 2012-2019.

INTRODUCTION: This manuscript characterizes primary and secondary prevention research in humans and related methods research funded by NIH in 2012‒2019. METHODS: The NIH Office of Disease Prevention updated its prevention research taxonomy in 2019‒2020 and applied it to a sample of 14,523 new extramural projects awarded in 2012-2019. All projects were coded manually for rationale, exposures, outcomes, population focus, study design, and type of prevention research. All results are based on that manual coding. RESULTS: Taxonomy updates resulted in a slight increase, from an average of 16.7% to 17.6%, in the proportion of prevention research awards for 2012‒2017; there was a further increase to 20.7% in 2019. Most of the leading risk factors for death and disability in the U.S. were observed as an exposure or outcome in <5% of prevention research projects in 2019 (e.g., diet, 3.7%; tobacco, 3.9%; blood pressure, 2.8%; obesity, 4.4%). Analysis of existing data became more common (from 36% to 46.5%), whereas randomized interventions became less common (from 20.5% to 12.3%). Randomized interventions addressing a leading risk factor in a minority health or health disparities population were uncommon. CONCLUSIONS: The number of new NIH awards classified as prevention research increased to 20.7% in 2019. New projects continued to focus on observational studies and secondary data analysis in 2018 and 2019. Additional research is needed to develop and test new interventions or develop methods for the dissemination of existing interventions, which address the leading risk factors, particularly in minority health and health disparities populations.