Abstract：
UNASSIGNED: Single-arm trials (SATs) and surrogate endpoints were adopted as pivotal evidence for accelerated approval of anticancer drugs for more than 30 years. However, concerns regarding clinical evidence quality in trials, particularly in the SATs of anticancer drugs have increasingly been raised. SAT may not always provide strong evidence due to the lack of control and endpoint of overall survival that is typically present in randomized controlled trials.
UNASSIGNED: Clinical trial endpoint adjudication is a crucial factor in surrogate outcome measurement to ensure the data quality of the clinical trial of anticancer drugs. In this review, we systematically discuss the characteristics of adjudications in assessments in surrogate endpoint and safety outcome respectively, which are essential for ensuring reliable and transparent outcomes. Endpoint adjudication effectively reduces potential bias and mitigates variance that may be introduced by investigators when analyzing the medical records for the surrogate endpoints. We analyze the advantages and disadvantages of each type of adjudicator and provide a summary of the roles of adjudicators.
UNASSIGNED: By suggestion of improving data reliability and transparency in pivotal trials, this review aims to supply a strategy for better clinical investigation for anticancer drugs, ultimately leading to better patient outcomes.
UNASSIGNED: Clinical trial endpoint adjudication is a crucial factor in surrogate outcome measurement to ensure the data quality of the clinical trial of anticancer drugs. In this review, we systematically discuss the characteristics of adjudications in assessments in surrogate endpoint and safety outcome respectively, which are essential for ensuring reliable and transparent outcomes. Endpoint adjudication effectively reduces potential bias and mitigates variance that may be introduced by investigators when analyzing the medical records for the surrogate endpoints. We analyze the advantages and disadvantages of each type of adjudicator and provide a summary of the roles of adjudicators.
UNASSIGNED: By suggestion of improving data reliability and transparency in pivotal trials, this review aims to supply a strategy for better clinical investigation for anticancer drugs, ultimately leading to better patient outcomes.
摘要：
■30多年来，单臂试验（SAT）和替代终点被用作加速批准抗癌药物的关键证据。然而,对试验中临床证据质量的担忧，特别是在SATs中的抗癌药物也日益增多。由于缺乏在随机对照试验中通常存在的总体生存的控制和终点，SAT可能并不总是提供强有力的证据。
■临床试验终点裁定是替代结果测量的关键因素，以确保抗癌药物临床试验的数据质量。在这次审查中,我们分别系统地讨论了替代终点和安全性结果评估中裁定的特点，这对于确保可靠和透明的结果至关重要。终点裁决有效地减少了潜在的偏差，并减轻了调查人员在分析替代终点的医疗记录时可能引入的差异。我们分析了每种类型的裁决者的优缺点，并对裁决者的角色进行了总结。
■通过建议提高关键试验中的数据可靠性和透明度，本文旨在为更好的抗癌药物临床研究提供策略，最终导致更好的患者结果。
■临床试验终点裁定是替代结果测量的关键因素，以确保抗癌药物临床试验的数据质量。在这次审查中,我们分别系统地讨论了替代终点和安全性结果评估中裁定的特点，这对于确保可靠和透明的结果至关重要。终点裁决有效地减少了潜在的偏差，并减轻了调查人员在分析替代终点的医疗记录时可能引入的差异。我们分析了每种类型的裁决者的优缺点，并对裁决者的角色进行了总结。
■通过建议提高关键试验中的数据可靠性和透明度，本文旨在为更好的抗癌药物临床研究提供策略，最终导致更好的患者结果。
