CSTP Projects

The CSTP team will complete four integrated projects that aim to: predict product toxicity in the aerosol research laboratory (Project 1), predict user behavior in the clinical laboratory (Project 2), predict product abuse liability in the clinical laboratory (Project 3) and assess potential regulation impact at the population level (Project 4).

A Contextual Knowledge Core uses mixed methods to ensure Projects 1-4 reflect the real world. A Career Enhancement Core conducts a tobacco regulatory science course, supports pre- and post-doctoral appointees and pilot projects. An Administrative Core supports financial/managerial processes, biostatistical needs, receives input from an External Advisory Board and interfaces with FDA, NIH and others.

Overall, CSTP’s integrative theme of impact analysis draws on the team’s expertise in tobacco product toxicity, user behavior, abuse liability and prospective cohort survey techniques. We seek to provide FDA with hypothesis-driven data regarding advanced generation ECIGs and test predictions about some potential regulations now, while developing a model that can be used to shape, refine and predict the effects of many potential regulatory actions in the future.

This research is supported by the National Institute on Drug Abuse of the National Institutes of Health and the Center for Tobacco Products of the U.S. Food and Drug Administration under Award Number U54DA036105. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration