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Social & Behavioral Science Research - Tips for Industry

In case you missed Dr. Zdinak's talk at TSRC, here's the presentation. Some points to highlight are:

  1. Why industry must recognize the difference between basic vs. applied behavioral science research, and understand how FDA's mindset impacts their expectations of research in your PMTAs and MRTPAs.

  2. FDA expects industry applicants to " appropriate study personnel for TPPI* studies. …involved in the design, implementation, and analysis of the TPPI study who have sufficient formal education, training, and experience in conducting social or behavioral science research to ensure the study is designed and conducted appropriately.” WHO you have designing and conducting your research MATTERS.

  3. FDA asks industry applicants to consider all aspects of research that a social and behavioral scientist does during doctoral-level training: Describe behavior, Monitor behavior, Predict behavior, & Explain behavior

  4. Silos get us nowhere - it only hurts the adult smoker who struggles every day with their combustible cigarette nicotine addiction. It's time to come together - First meeting of the Consortium for Tobacco Harm Reduction will be end of October 2022, with a first focus on an e-learning curriculum for healthcare providers. Dr. Zdinak's work on developing an e-learning curriculum for healthcare providers on domestic violence/intimate partner violence is the foundation for this ARAC initiative.

108 Zdinak - Social and Behavioral Science Research-Best Practices Methodological Conside
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