# Stream trial data to regulators as it accrues; review starts at last patient visit

Source: https://onco.cc/ideas/idea-reg-realtime-streaming-submission/  
OnCo record `idea-reg-realtime-streaming-submission` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- FDA Real-Time Oncology Review: https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review

## Connected records

- bottlenecks: [Data silos](https://onco.cc/bottlenecks/b-data-silos/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

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