School of Medicine and Health Sciences Poster Presentations

Title

Cross-disciplinary Integration in FDA Team Science

Document Type

Poster

Abstract Category

Health Sciences

Keywords

Team Science, Interdisciplinary Integration, Cross-disciplinary Integration, FDA

Publication Date

Spring 5-1-2019

Abstract

The Food and Drug Administration (FDA) is responsible for assessing the safety and effectiveness of new drug products before they can be legally marketed and used in clinical practice. This is a critical translational activity on the biomedical research continuum. In order to conduct these assessments, the FDA forms teams with varying degrees of cross-disciplinarity, ranging from cooperative multidisciplinary interactions to more intense collaborative problem-solving transdisciplinary interactions. An initial literature review has suggested gaps in knowledge regarding how these cross-disciplinary teams operate, specifically when their integrative capacity and processes are considered. These gaps hamper the FDA's ability to develop practical guidelines to promote the team effectiveness of its assessments and to evaluate the success of interventions that promote cross-disciplinary integration. To address this gap, a mixed-methods, comparative case study has been designed to research the cross-disciplinary integration of FDA teams. The inquiry leverages the theoretical framework of integration postulated by O’Rourke, Crowley and Gonnerman (2016) and a context specific process model of FDA's assessment of new drug products to create a conceptual framework for further research which includes evaluation indicators related to integration processes, both quantitative and qualitative. Characterizing the cross-disciplinary integration process using this framework may suggest how purposeful selection of FDA teams with high and low integration for a comparative case study of the skills, abilities and practices at the team level can inform practical guidelines to promote effective cross-disciplinary integration. O’Rourke, M., Crowley, S., & Gonnerman, C. (2016). On the nature of cross-disciplinary integration: A philosophical framework. Studies in History and Philosophy of Science Part C :Studies in History and Philosophy of Biological and Biomedical Sciences, 56, 62–70. https://doi.org/10.1016/j.shpsc.2015.10.003

Open Access

1

Comments

Presented at Research Days 2019.

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Cross-disciplinary Integration in FDA Team Science

The Food and Drug Administration (FDA) is responsible for assessing the safety and effectiveness of new drug products before they can be legally marketed and used in clinical practice. This is a critical translational activity on the biomedical research continuum. In order to conduct these assessments, the FDA forms teams with varying degrees of cross-disciplinarity, ranging from cooperative multidisciplinary interactions to more intense collaborative problem-solving transdisciplinary interactions. An initial literature review has suggested gaps in knowledge regarding how these cross-disciplinary teams operate, specifically when their integrative capacity and processes are considered. These gaps hamper the FDA's ability to develop practical guidelines to promote the team effectiveness of its assessments and to evaluate the success of interventions that promote cross-disciplinary integration. To address this gap, a mixed-methods, comparative case study has been designed to research the cross-disciplinary integration of FDA teams. The inquiry leverages the theoretical framework of integration postulated by O’Rourke, Crowley and Gonnerman (2016) and a context specific process model of FDA's assessment of new drug products to create a conceptual framework for further research which includes evaluation indicators related to integration processes, both quantitative and qualitative. Characterizing the cross-disciplinary integration process using this framework may suggest how purposeful selection of FDA teams with high and low integration for a comparative case study of the skills, abilities and practices at the team level can inform practical guidelines to promote effective cross-disciplinary integration. O’Rourke, M., Crowley, S., & Gonnerman, C. (2016). On the nature of cross-disciplinary integration: A philosophical framework. Studies in History and Philosophy of Science Part C :Studies in History and Philosophy of Biological and Biomedical Sciences, 56, 62–70. https://doi.org/10.1016/j.shpsc.2015.10.003