PKRxiv: A Best Practice Model for Advancing Pharmacoequity Through Open Pharmacokinetic Data Sharing

Le résumé fourni par la source

Model-informed drug development is increasingly integrated across the drug development continuum, enabling more efficient, cost-effective, and targeted trials while reducing reliance on animal studies. Achieving pharmacoequity requires not only equitable access to medicines but also to the data and knowledge that inform drug development and regulatory decisions. To address challenges in pharmacokinetic data sharing, PKRxiv (https://pkrxiv.org/) was developed as a discipline-specific repository designed around Findable, Accessible, Interoperable, Reusable (FAIR) principles. This tutorial introduces PKRxiv's rationale, design, data submission and access workflows, and practical use cases. Available datasets at the end of September 2025 include over 5,500 individual drug concentration-time data points from over 900 unique participants across 3 continents. The platform supports structured submission of pharmacokinetic, pharmacogenetic, and safety/efficacy data, with persistent digital object identifiers for discoverability and citation. Contributors can apply one of three data sharing models-unrestricted, noncommercial, or contributor-controlled-with optional embargo periods. Users can explore datasets using the Data Explorer or Data Cards, or submit requests after providing a statement of intended use case. It enables pooling of datasets across multiple studies. Recommendations to help advance the field are proposed as data sharing becomes more widely expected: obtaining consent for unspecified future research use of data, sharing data underlying peer-reviewed publications as standard practice, including discipline-specific repositories in data management plans, and incentivizing post-approval data sharing by industry. Supporting data from all therapeutic areas and population groups, PKRxiv is a critical step toward a more transparent, equitable, and collaborative future in clinical pharmacology research.

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