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.
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.
Cost to try
Medium ($1M to $50M)
Bottlenecks it attacks
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Data silos · Records, scans, genomes and outcomes sit in separate systems that cannot talk. Every patient's experience is lost to the next.