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Recognizing the importance of real-world data (RWD) for regulatory purposes,the United States (US) Congress passed the 21st Century Cures Act1 mandatingthe development of Food and Drug Administration (FDA) guidance on regulatoryuse of real-world evidence. The Forum on the Integration of Observational andRandomized Data (FIORD) conducted a meeting bringing together variousstakeholder groups to build consensus around best practices for the use of RWDto support regulatory science. Our companion paper describes in detail thecontext and discussion carried out in the meeting, which includes arecommendation to use a causal roadmap for complete pre-specification of studydesigns using RWD. This article discusses one step of the roadmap: thespecification of a procedure for sensitivity analysis, defined as a procedurefor testing the robustness of substantive conclusions to violations ofassumptions made in the causal roadmap. We include a worked-out example of asensitivity analysis from a RWD study on the effectiveness of Nifurtimox intreating Chagas disease, as well as an overview of various methods availablefor sensitivity analysis in causal inference, emphasizing practicalconsiderations on their use for regulatory purposes.

Sensitivity analysis for causality in observational studies for regulatory science