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ideasIdea

Just-in-time site activation: open a site in two weeks when a patient appears

Instead of opening a trial at fifty hospitals and waiting for patients, keep a network of pre-vetted clinics ready and switch a trial on where a matching patient is found.

A network of community and academic sites holds master agreements, a central IRB, standing budgets and trained staff; when a matched patient is identified (via matching tools or referral), the site is activated for that protocol within 10-14 days. TAPUR and some rare-tumour and biomarker-defined trials have used this model; the idea is to make it the default for biomarker-selected phase 2 and rare-cancer trials and to fund the network as infrastructure.

Hypothesis
Biomarker-selected trials run through a just-in-time network will reach target accrual in less than half the calendar time of conventional site selection and at lower cost per enrolled patient, because idle-site costs are removed.
Rationale
In conventional trials a large share of opened sites enrol zero or one patient, while eligible patients at non-participating sites are never enrolled. JIT inverts the logic: capacity follows the patient.
What would test it
Run two similar biomarker-selected phase 2 studies from one sponsor, one via JIT network and one via conventional site selection, and compare time to accrual, cost per patient and geographic spread of enrolled patients.
Maturity
early clinical
Who has to act
industry
Cost to try
Medium ($1M to $50M)
Years to first evidence
2
Bottlenecks it attacks

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