The uptake of a new medicine represents a balance between benefit–risk assessment and value considerations. In the case of products approved via accelerated pathways, the increased uncertainty adds to the challenge. Here, we suggest solutions so that regulators, companies, payers and patients can align around management of the uncertainties and expectations.

中文翻译：

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药品加速批准：是否适合目的？

新药的使用代表了利益风险评估和价值考虑之间的平衡。对于通过加速途径批准的产品，不确定性的增加加剧了挑战。在这里，我们提出解决方案，以便监管机构，公司，付款人和患者可以围绕不确定性和期望的管理进行调整。