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Thousands of patients have received standard treatment in the control arms of past trials. Pooling their anonymised data would let new trials borrow from them and randomise fewer patients to old treatments.
A curated commons of individual patient data from control arms of completed oncology trials, standardised by indication, line of therapy and era, with covariates sufficient for matching and Bayesian borrowing, governed by the data trust and accepted by regulators as a source for external or hybrid control arms under pre-specified conditions. Sponsors contributing control data receive access rights. Regulators (FDA's real-world evidence and complex innovative design programmes, EMA's qualification opinions) have signalled openness to external controls where data quality is high; the commons provides the quality and the scale.
Shares Real-world evidence, Trials enrol too few, too slowly, Trial design, endpoints and cost.
Shares Standard of care, Real-world evidence, Trials enrol too few, too slowly, Trial design, endpoints and cost.
Shares Standard of care, Trials enrol too few, too slowly, Trial design, endpoints and cost.
Shares Secrecy and intellectual property block collaboration, Trials enrol too few, too slowly, Trial design, endpoints and cost.
Shares Real-world evidence, Trials enrol too few, too slowly, Trial design, endpoints and cost.
Shares A single oncology trial data trust with mandatory deposit within eighteen months, Secrecy and intellectual property block collaboration.
Shares A single oncology trial data trust with mandatory deposit within eighteen months, Secrecy and intellectual property block collaboration.
Shares A single oncology trial data trust with mandatory deposit within eighteen months, Secrecy and intellectual property block collaboration.