Prevailing uncertainties regarding the therapeutic interchangeability of PD-1 and PD-L1 inhibitors affect both clinical decision making and health-care budgeting. This Personal View presents a comprehensive assessment of the fragmented regulatory landscape of PD-1 and PD-L1 inhibitors, highlighting the complex dynamics of market competition, pricing, and the effect on health-care budgets. Our paper explores the current state of clinical trials, uninformative trial designs, and the challenges they pose in evaluating the therapeutic interchangeability of these drugs. To address these challenges, research that will inform us of the extent of interchangeability of PD-1 and PD-L1 inhibitors is needed. We recommend head-to-head randomised controlled trials, standardised study designs for indirect comparisons, trials with monotherapy groups, post-approval trials funded from private or public sources, and adoption of a near-equivalence framework in both conducting and evaluating trials.

中文翻译：

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免疫检查点抑制剂的互换性：迫切需要采取行动


关于 PD-1 和 PD-L1 抑制剂治疗互换性的普遍不确定性影响临床决策和医疗保健预算。本个人观点对 PD-1 和 PD-L1 抑制剂的分散监管环境进行了全面评估，强调了市场竞争、定价和对医疗保健预算影响的复杂动态。我们的论文探讨了临床试验的现状、无信息量的试验设计，以及它们在评估这些药物的治疗互换性时带来的挑战。为了应对这些挑战，需要进行研究，让我们了解 PD-1 和 PD-L1 抑制剂的互换性程度。我们建议进行头对头随机对照试验、用于间接比较的标准化研究设计、单药治疗组的试验、由私人或公共来源资助的批准后试验，以及在实施和评价试验时采用近乎等效的框架。