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Companies lose money when they prove a shorter course works, so they never test it. Give them a modest reward, such as extra months of exclusivity, when they do.
Regulators grant a defined exclusivity extension (for example six months, as for paediatric studies) to sponsors who complete an adequately powered randomised trial of treatment duration, stopping rules or dose de-escalation for an approved oncology drug within a set period after approval, regardless of the result. Alternatively, such trials become a condition of full approval after accelerated approval. Most immunotherapy is given for two years or until progression with no evidence for either; a legislated carrot that outweighs revenue loss from shorter courses could fix the incentive at low public cost.
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Shares Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape, Incentives reward me-too drugs and marginal gains, Nivolumab, Pembrolizumab.
Shares Incentives reward me-too drugs and marginal gains, Toxicity and quality of life are undervalued, Pembrolizumab.
Shares Osimertinib, Nivolumab, Pembrolizumab.
Shares Patent term extension scaled to proven survival gain, Incentives reward me-too drugs and marginal gains.