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Instead of waiting months for a company to package trial results, regulators would see the data flow in during the trial and could decide within weeks of it ending.
FDA's Real-Time Oncology Review allows early submission of top-line data and datasets; this proposal goes further, with a standardised, validated data pipeline (CDISC SDTM/ADaM generated continuously from the sponsor's EDC) delivered to a shared regulator environment under blinded access controls during the trial. At database lock the regulator already holds cleaned data; the assessment starts immediately and the label negotiation is the only serial step.
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