Evaluating integration in collaborative cross-disciplinary FDA new drug reviews using an input-process-output model

Area of Science:

• Drug regulatory science
• Team science
• Organizational behavior

Background:

• The US Food and Drug Administration (FDA) assesses new drug safety and effectiveness.
• FDA utilizes cross-disciplinary review teams for these assessments.
• Recent FDA initiatives focus on interdisciplinary approaches to improve review efficiency and integration.

Purpose of the Study:

• To compare the impact of FDA's new interdisciplinary review approach on team integration versus the traditional multidisciplinary approach.
• To model and analyze collaborative integration within FDA review teams.

Main Methods:

• A phenomenological descriptive comparative case study was conducted.
• Two FDA review teams were studied: one using the new interdisciplinary approach and one using the traditional multidisciplinary approach.
• An input-process-output (IPO) model from Science-of-Team-Science (SciTS) was used to analyze collaborative integration.

Main Results:

• Collaborative integration was identified in both interdisciplinary and multidisciplinary review teams.
• The study modeled and analyzed the cross-disciplinary integration within each team using the IPO model.
• The new interdisciplinary approach demonstrated greater team integration compared to traditional methods.

Conclusions:

• A systematic method for visualizing and understanding review team integration at the FDA was established.
• The interdisciplinary approach shows potential for enhanced integration and reduced redundancy in drug review processes.
• The IPO model effectively characterizes FDA review team integration and can evaluate differences between review approaches, serving as a model for measuring review team effectiveness.