# A regulator-endorsed standard contract for inter-company combination trials

Source: https://onco.cc/ideas/idea-fund-standard-combination-agreement/  
OnCo record `idea-fund-standard-combination-agreement` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Most of the delay in testing two companies' drugs together is lawyers negotiating from scratch. A single standard agreement, blessed by regulators, would let them sign in weeks.

## Summary

A model clinical collaboration agreement for combination studies, covering supply, cost sharing, safety data exchange, publication, data ownership, background and foreground IP and regulatory filing rights, developed by an industry consortium (TransCelerate or a similar body) with academic networks and endorsed by the FDA and EMA as consistent with their combination-development guidance. Companies pre-commit to accept the template without modification for trials meeting defined criteria. Standard templates have cut contract time dramatically in academic-industry clinical trial agreements (for example the UK's model Clinical Trial Agreement and the US Accelerated Clinical Trial Agreement).

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Adoption of a standard combination agreement by ten large oncology companies reduces the median time from scientific agreement to signed contract for cross-company combination trials from over twelve months to under three, and increases such trials by a third within two years.
- Rationale: The UK model CTA reduced negotiation times from months to weeks across NHS trusts; TransCelerate's shared investigator platform and common protocol template show that competitors will standardise operational documents when regulators and sponsors align. Combination agreements are the last major bespoke document.
- Proposed test: Develop the template with a consortium and pilot it on twenty combination trials, measuring negotiation time and deviations from the template against a matched set of bespoke agreements.
- Maturity: speculative
- Actor: industry

## Sources

- TransCelerate BioPharma: https://www.transceleratebiopharmainc.com/

## Connected records

- ideas: [A universal material transfer agreement with a thirty-day default](https://onco.cc/ideas/idea-fund-universal-mta-fast-lane/), [An oncology patent pool for combination trials across companies](https://onco.cc/ideas/idea-fund-combination-patent-pool/)
- bottlenecks: [Secrecy and intellectual property block collaboration](https://onco.cc/bottlenecks/b-ip-collaboration/), [Too many combinations to test](https://onco.cc/bottlenecks/b-combination-space/)

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