# Sponsors deposit the confirmatory trial budget in escrow at accelerated approval

Source: https://onco.cc/ideas/idea-reg-confirmatory-trial-escrow/  
OnCo record `idea-reg-confirmatory-trial-escrow` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

To get an early approval, a company would set aside the money for the follow-up trial up front, so the trial cannot be quietly abandoned.

## Summary

Confirmatory trials for accelerated approvals are often delayed or redesigned in ways that reduce their chance of a clear answer. The proposal is a financial escrow: at approval the sponsor deposits the estimated cost of the pre-agreed confirmatory trial with an independent trustee. The funds are released against enrolment and reporting milestones; if the sponsor defaults, the trustee funds an academic cooperative group to complete the trial. This complements, rather than replaces, an automatic sunset.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Escrow-backed confirmatory trials reach their primary readout a median of 18 months sooner than historical confirmatory trials, and the proportion never reported falls to near zero.
- Rationale: Escrow converts a soft regulatory commitment into a hard financial one and creates a funded route for independent completion when commercial interest wanes (for example after a competing product launches). Environmental remediation bonds work on the same logic.
- Proposed test: Legislative pilot in one region for new accelerated oncology approvals; compare time to confirmatory readout with concurrent non-escrow approvals elsewhere.
- Maturity: speculative
- Actor: policy

## Sources

- Bottleneck evidence (Regulatory divergence between regions): FDA Oncology Center of Excellence, Project Orbis: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

## Connected records

- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)
- roadmaps: [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

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