A shared library of pooled control arms to shrink and speed future trials
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.
- Secrecy and intellectual property block collaboration · Companies with complementary drugs rarely test them together, and data that could answer questions stays locked up.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
- Trials enrol too few, too slowly · Fewer than one in ten adults with cancer joins a trial. Trials close for lack of patients, not lack of ideas.
Pages like this
not linked directly; found by shared links- IdeaRandomise inside the cancer registry: registry-based trials for everyday questions
Shares Standard of care, Trials enrol too few, too slowly, Real-world evidence, Trial design, endpoints and cost.
- IdeaPoint-of-care randomisation built into the oncology record
Shares Trials enrol too few, too slowly, Real-world evidence, Trial design, endpoints and cost.
- IdeaBorrow from past control arms to shrink the control group in phase 3
Shares Standard of care, Trials enrol too few, too slowly, Trial design, endpoints and cost.
- IdeaCompeting sponsors share one control arm in the same indication
Shares Secrecy and intellectual property block collaboration, Trials enrol too few, too slowly, Trial design, endpoints and cost.
- IdeaRegistry-based randomised trials for oncology comparative effectiveness
Shares Trials enrol too few, too slowly, Real-world evidence, Trial design, endpoints and cost.
- IdeaAn antitrust safe harbour for cross-company combination trials and data pooling
Shares A single oncology trial data trust with mandatory deposit within eighteen months, Secrecy and intellectual property block collaboration.
- IdeaA public registry of stalled academic assets and shelved company compounds
Shares A single oncology trial data trust with mandatory deposit within eighteen months, Secrecy and intellectual property block collaboration.
- IdeaPatient-held portable consent for reusing samples and data across studies
Shares A single oncology trial data trust with mandatory deposit within eighteen months, Secrecy and intellectual property block collaboration.