OnCo
ideasIdea

A standard cross-company combination agreement that takes weeks, not years, to sign

Companies with drugs that might work together rarely test them because the legal negotiation takes longer than the trial. A pre-written standard contract would fix that.

The CRUK Combinations Alliance and NCI CTEP show that a neutral third party with template agreements can run combination studies across companies. Extending this to an industry-wide, pre-negotiated 'combination clinical trial agreement' (like the standard licences in software) covering supply, data, publication, IP on combination findings and a default revenue rule would remove the largest non-scientific barrier.

Hypothesis
Adoption of a template agreement by at least ten large sponsors will halve the median time from combination hypothesis to first patient dosed in academic-led cross-company combination trials.
Rationale
Standard material transfer and clinical trial agreements (for example the Accelerated Clinical Trial Agreement in the US) have already cut academic site contracting times. The combination-specific clauses (who owns a method-of-use patent, who supplies free drug) are the ones that stall.
What would test it
Draft with a neutral convenor (for example a cancer charity plus a trade body), sign with a coalition of sponsors, and measure time-to-agreement and time-to-first-patient for the next twenty combination trials versus the twenty before.
Maturity
early clinical
Who has to act
industry
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks

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