PDF(Pubmed)
Abstract：
As clinical trials in oncology require substantial efforts, maximizing the insights gained from them by conducting subgroup analyses is often attempted. The goal of these analyses is to identify subgroups of patients who are likely to benefit, as well as the subgroups of patients who are unlikely to benefit from the studied intervention. International guidelines occasionally include or exclude novel medications and technologies for specific subpopulations based on such analyses of pivotal trials without requiring confirmatory trials. This Perspective discusses the importance of providing a complete dataset of clinical information when reporting subgroup analyses and explains why such transparency is key for better clinical interpretation of the results and the appropriate application to clinical care, by providing examples of transparent reporting of clinical studies and examples of incomplete reporting of clinical studies.
摘要：
由于肿瘤学的临床试验需要大量的努力，经常尝试通过进行子群分析来最大化从他们那里获得的见解。这些分析的目标是确定可能受益的患者亚组，以及不太可能从研究干预中受益的患者亚组。国际指南偶尔包括或排除基于关键试验的此类分析的针对特定亚群的新药物和技术，而无需进行确认试验。本观点讨论了在报告亚组分析时提供完整的临床信息数据集的重要性，并解释了为什么这种透明度对于更好地对结果进行临床解释以及在临床护理中的适当应用至关重要。通过提供临床研究透明报告的示例和临床研究不完整报告的示例。
