Document Type

Dissertation

Date of Degree

Fall 12-21-2020

Keywords

United States Food and Drug Administration; Cross-disciplinary integration; New Drugs Regulatory Program; Center for Drug Evaluation and Research (CDER)

Abstract

Cross-disciplinary integration is a key feature of interdisciplinary research and the collaborative form is often one of the desired outcomes of Team Science endeavors. In 2019 the FDA began rolling out a new interdisciplinary approach to their cross-disciplinary assessment of marketing applications, with the key feature being integrated, collaborative review documents (Woodcock et al., 2020). FDA’s assessment of new drug products to allow them to enter the marketplace is a critical translational activity to protect the US public’s health that requires team-based integration and transparency (Woodcock, 2018). And, while increased cross-disciplinary integration through enhanced collaboration and communication is sought through this intervention, FDA and in fact the Science-of-Team-Science, arguably lack examples of a rigorous approach to the objective evaluation of integration. Through a phenomenological descriptive comparative case study we identify, model, and analyze multiple instances of collaborative integration occurring in different FDA review teams using either their new interdisciplinary review or their traditional multidisciplinary review processes to evaluate the impact of the intervention to promote integration (Bugin, 2021). This study applies a framework of cross-disciplinary integration from the philosophy of Team Science using an input-process-output (IPO) model (O’Rourke et al., 2016). This framework is coupled with the FDA’s structured benefit-risk framework for assessing the approvability of new drug products, and used to guide data collection and analysis, and the interpretation of integration (FDA, 2018). Integration is observed in both review processes, confirming that FDA team-based new drug product marketing application reviews are indeed demonstrating collaborative cross-disciplinary research activities per the cross-disciplinary integration framework. Furthermore, findings indicate that the cross-disciplinary integration framework and associated IPO model can be applied in the evaluation of collaborative cross-disciplinary integration, and that the method is sensitive enough to enable analytical comparisons. Through these comparisons, the study importantly demonstrates that the FDA’s most recent improvement to its assessment of new drug product marketing applications, a new interdisciplinary review process with the use of more integrated documentation, is more integrative in comparison to the traditional multidisciplinary review process as illustrated in multiple integrative analyses and visualizations.

Creative Commons License

Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

Open Access

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