Reproducibility data and analysis code for "Expedited pathway portfolios, trial complexity, and FDA approval timelines in oncology and neurology: a comparative analysis"

This record contains the reproducibility package supporting the article “Expedited pathway portfolios, trial complexity, and FDA approval timelines in oncology and neurology: a comparative analysis.” The package includes the final R analysis script (version 6.2), processed product-level and curated product–NCT link-level datasets, curated linkage audits, statistical tables, figure-source data, counterfactual and economic-translation outputs, robustness analyses, supplementary predictive sensitivity outputs, quality-control files, and a file manifest. The study examined 195 original U.S. Food and Drug Administration approvals from 2015 through 2024, comprising 136 oncology products and 59 neurology products. Pivotal or registrational evidence was curated from FDA labels and review documents and enriched through exact NCT matching to AACT. The final evidence dataset contained 221 product–NCT pivotal links representing 220 distinct NCT identifiers. The analyses used publicly available FDA regulatory and trial-registry records and did not include individual-level patient data, identifiable private information, or direct participant data. This repository is intended to support verification and reproduction of the analyses reported in the associated article.