{"entity":{"id":"idea-reg-realtime-streaming-submission","kind":"idea","name":"Stream trial data to regulators as it accrues; review starts at last patient visit","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"FDA Real-Time Oncology Review","url":"https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-regulatory-fragmentation","b-data-silos"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Streaming submission cuts the interval from database lock to approval decision for positive pivotal oncology trials to under 60 days, compared with a current median of roughly 8-12 months including dossier preparation.","rationale":"Most of the time between a positive readout and approval is dossier assembly and sequential question rounds, not scientific deliberation. RTOR has already shown that approvals can follow readouts by weeks when data arrive early.","test":"Pilot with five sponsors on five phase 3 trials with streaming submission to FDA and EMA jointly; measure lock-to-decision time and the number of information requests against matched RTOR and conventional reviews.","maturity":"early-clinical","actor":"regulator","cost":"medium","horizonYears":3},"route":"/ideas/idea-reg-realtime-streaming-submission/","neighbours":{"bottleneck":[{"id":"b-data-silos","kind":"bottleneck","name":"Data silos","route":"/bottlenecks/b-data-silos/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}