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A Contextual Inquiry: FDA Investigational New Drug Clinical Review
Jonathan Bidwell1,2, Kara Whelply1,2, Sophia Shepard3
1U.S. Food and Drug Administration (FDA), Silver Spring, MD, US.
Abstract:
The U.S. Food and Drug Administration (FDA) is modernizing IT infrastructure and investigating software requirements for addressing increased regulator workload and complexity requirements during Investigational New Drug (IND) reviews. We conducted a mixed-method, Contextual Inquiry (CI) study for establishing a detailed understanding of daily IND-related research, writing, and decision-making tasks. Individual reviewers faced notable challenges while attempting to search, transfer, compare, consolidate and reference content between multiple documents. The review process would likely benefit from the development of software tools for both addressing these problems and fostering existing knowledge sharing behaviors within individual and group settings.
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