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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.
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.
Shares Accelerated approval, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Incentives reward me-too drugs and marginal gains, Regulatory divergence between regions.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Regulatory divergence between regions.
Shares Accelerated approval, Regulatory divergence between regions.
Shares Accelerated approval, Incentives reward me-too drugs and marginal gains.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Regulatory divergence between regions.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Incentives reward me-too drugs and marginal gains.
Shares Accelerated approval, Regulatory divergence between regions.
Shares Accelerated approval, Regulatory divergence between regions.
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