Abstract
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. 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. 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). 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.
Highlights
Cross-disciplinary integration is a key feature of interdisciplinary research and the collaborative form is often a desired outcome of Team Science[1,2,3]
This study deployed a phenomenological descriptive comparative case study approach to identify and characterize the nature of the collaborative integration occurring in Food and Drug Administration (FDA) review teams for two new drug product marketing applications using two different forms of cross-disciplinary research
Key review issues are the focus of all marketing application reviews, new and old, as they form the basis of benefit-risk assessment, i.e., assessment of whether a patient taking the proposed new drug product will experience greater therapeutic benefits than risks, such as adverse reactions commonly termed “side effects”
Summary
Cross-disciplinary integration is a key feature of interdisciplinary research and the collaborative form is often a desired outcome of Team Science[1,2,3]. This study deployed a phenomenological descriptive comparative case study approach to identify and characterize the nature of the collaborative integration occurring in FDA review teams for two new drug product marketing applications using two different forms of cross-disciplinary research. As Julie Thompson Klein articulated in her discussion of interdisciplinarity, this integration increases across the continuum of cross-disciplinary research from unidisciplinarity to transdisciplinarity and is characterized heuristically by different forms of integration[4]. For this reason, integration is expected in a multidisciplinary case and in an interdisciplinary case, but it should be somewhat different. Key review issues are the focus of all marketing application reviews, new and old, as they form the basis of benefit-risk assessment, i.e., assessment of whether a patient taking the proposed new drug product will experience greater therapeutic benefits than risks, such as adverse reactions commonly termed “side effects”
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