Assessments of clinical evidence vary between regulators and health technology assessment bodies, but precise differences remain unclear. To compare uncertainties raised on the clinical evidence of approved drugs, we analyzed assessments of regulators and health technology assessment (HTA) bodies in the United States and Europe. We found that US and European regulators report uncertainties related to safety for almost all drugs (85–94%), whereas HTA bodies reported these less (53–59%). By contrast, HTA bodies raised uncertainties related to effects against relevant comparators for almost all drugs (88–100%), whereas this was infrequently addressed by regulators (12–32%). Regulators as well as HTA bodies reported uncertainties related to the patient population for 60–95% of drugs. The patterns of regulator‐HTA misalignment were comparable between the United States and Europe. Our results indicate that increased coordination between these complementary organizations is necessary to facilitate the collection of necessary evidence in an efficient and timely manner.

中文翻译：

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不确定性下的决策：在美国和欧洲比较法规和卫生技术评估药品评论。

监管机构和卫生技术评估机构之间对临床证据的评估不尽相同，但尚不清楚确切的差异。为了比较批准药物的临床证据引起的不确定性，我们分析了美国和欧洲的监管机构评估和健康技术评估（HTA）机构。我们发现，美国和欧洲的监管机构报告了几乎所有药物安全性的不确定性（85-94％），而HTA机构报告的不确定性则较小（53-59％）。相比之下，HTA机构对几乎所有药物（88–100％）对相关比较者的作用均带来不确定性，而监管机构却很少解决（12–32％）。监管机构以及HTA机构报告了60-95％的药物与患者人群有关的不确定性。在美国和欧洲之间，调节器与HTA错位的模式具有可比性。我们的结果表明，这些补充组织之间需要加强协调，以促进以高效，及时的方式收集必要的证据。