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Scientific article published on 28 July 2016
Multiple reproducible models exist for sharing patient‑level clinical trial data that balance privacy and commercial confidentiality: technical anonymization standards and privacy metrics, governance ...
or failure to share individual participant data (IPD) does materially impede scientific verification, secondary analyses, and cumulative knowledge-building, but it does not exist in a vacuum: legitima...
De‑identification and redaction are double‑edged tools: they reduce re‑identification risk but can materially impair independent reanalysis by removing, suppressing, or perturbing the very variables a...
There is no single, universally accepted technical standard for anonymizing patient‑level clinical trial data; instead a patchwork of statistical metrics, industry guidance, platform rules and nationa...
Regulators — principally the European Medicines Agency (EMA), national competent authorities in the EU, the US Food and Drug Administration (FDA), Health Canada and similar national agencies — hold fu...