J Clin Transl Sci
Cross-disciplinary integration; FDA; benefit-risk assessment; evaluation; science-of-team-science.
Background/Objectives: The US Food and Drug Administration (FDA) is responsible for assessing safety (risks) and effectiveness (benefits) of new drug products using the data provided in a Sponsor's new drug product marketing application before they can be marketed. The FDA forms cross-disciplinary review teams to conduct these assessments. Recently, the FDA began implementing more interdisciplinary approaches to its assessments, reducing redundancy in review processes and documentation by increasing team integration around review issues.
Methods: Through a phenomenological descriptive comparative case study, the impact of FDA's new interdisciplinary approach on review team integration was compared with its traditional multidisciplinary review approach.
Results: We identified collaborative integration occurring in one FDA review team using the new interdisciplinary review and another team using the traditional review and then modeled and analyzed the collaborative, cross-disciplinary integration in each case using an input-process-output (IPO) model drawn from the Science-of-Team-Science (SciTS).
Conclusion: This study provides a systematic method for understanding and visualizing integration in each type of review previously and presently used at FDA and illustrates how the new interdisciplinary approach can ensure more integration than more traditional approaches previously used. In addition, our study suggests that an IPO model of integration can characterize how effectively FDA review teams are integrating around issues and assist in the evaluation of differences in integration between FDA's new interdisciplinary review and the existing multidisciplinary approach. The approach used here is a new application of SciTS scholarship in a unique sector, and it also serves as an example for measuring review team effectiveness.
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Bugin, K., Lotrecchiano, G. R., O'Rourke, M., & Butler, J. (2021). Evaluating integration in collaborative cross-disciplinary FDA new drug reviews using an input-process-output model.. J Clin Transl Sci, 5 (1). http://dx.doi.org/10.1017/cts.2021.861