FDA and NIH Release Seventh Wave Biomarker Data
The Seventh Wave biomarker data file was released by the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH). For the first time, this release includes biomarker data collected between January 2022 and April 2023.
Overview of the PATH Study
According to data from the FDA and the National Institute on Drug Abuse (NIDA). The Population Assessment of Tobacco and Health (PATH) study has jointly released the Seventh Wave Biomarker Data File (BRUF). This marks the first public availability of data from this wave, covering research conducted from January 2022 to April 2023.
Purpose and Background of the Research
As stated on the FDA’s website, the PATH study is a large-scale, long-term investigation into tobacco use and its health impacts in the United States. Conducted by the FDA’s Center for Tobacco Products in collaboration with the NIH’s National Institute on Drug Abuse, the study began in 2011, with the first data collection wave launched in 2013.
The primary goal of the PATH study is to help scientists understand:
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How and why do people begin using tobacco?
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Why and how they quit?
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Why do some relapse after quitting?
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The health effects of different tobacco products, particularly on the cardiovascular and respiratory systems.
The findings from this ongoing study support the FDA’s efforts to develop policies and regulations under the Family Smoking Prevention and Tobacco Control Act.
Access to Biomarker Data and Updates
According to the FDA, researchers can request access to the restricted biomarker data files (BRUF). Additionally, updates have been made to the first wave of data files, now including adult participants who have used any type of tobacco product—either experimentally or long-term.
The restricted and public-use master linkage files have also been updated to reflect the inclusion of the new biomarker data and biological samples available through the PATH program.
The address of the seventh-wave biomarker data file on the FDA website is as follows:
https://www.icpsr.umich.edu/web/NAHDAP/studies/36840/summary
