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首页> 外文期刊>Drug Design, Development and Therapy >Are Laboratory Parameter (Biomarker) Values Similar to the Healthy Volunteer Reference Range in Individuals with Diabetes
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Are Laboratory Parameter (Biomarker) Values Similar to the Healthy Volunteer Reference Range in Individuals with Diabetes

机译：是实验室参数（生物标志物）值类似于糖尿病个体的健康志愿者参考范围

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Background: Identification of laboratory parameter clinical safety signals depends on the terminology and scoring criteria. Grade 1 scoring criteria in the Common Terminology Criteria for Adverse Events (CTCAE) is typically based on the healthy volunteer reference range (HVRR). The objectives of this study were to determine 1) what laboratory parameters in individuals with diabetes are potentially different from the HVRR and 2) what fold change from baseline should be expected in this population. Materials and Methods: Baseline data from the individuals with diabetes clinical trial data (TransCelerate dataset) were compared to the HVRR using a 10% threshold above HVRR to classify laboratory parameters as potentially different from the HVRR. These parameters were then evaluated longitudinally to determine the expected x-baseline values for individuals with diabetes for potential use in identifying drug-induced changes. Results: The baseline data determined that 28% of the laboratory parameters evaluated were potentially different from the HVRR. Longitudinal data analysis determined 1) thresholds for 13 of these laboratory parameters with the subjects above the threshold having greater variability than those below the threshold, and 2) the expected upper limits (x-baseline) were calculated for the laboratory parameters. For example, a 1.8– 2.6 x-baseline value for alanine aminotransferase, depending on how the baseline is calculated, is expected in individuals with diabetes. Conclusion: It is not uncommon for laboratory parameters in individuals with diabetes clinical trials to be potentially different from the HVRR, and the x-baseline criteria for 13 of these laboratory biomarkers was determined for this population. This suggests consideration in modifying the current CTCAE grade 1 criteria of 1.5– 3.0 x-baseline should be further investigated as to if the current criteria detects too many false-positive signals in this population.
机译：背景：实验室参数识别临床安全信号取决于术语和评分标准。 1级的不良事件（CTCAE）共同术语标准的评分标准通常基于健康的志愿者参考范围（HVRR）。本研究的目的是确定1）糖尿病中个体的实验室参数可能与HVRR和2）的潜在不同，2）应该预期从基线的倍数发生变化。材料和方法：将来自糖尿病患者临床试验数据（转发数据集）的基线数据与HVRR高于HVRR以上的10％阈值进行比较，以将实验室参数分类为与HVRR不同。然后纵向评估这些参数以确定具有糖尿病的个体的预期X基线值，以识别药物诱导的变化。结果：基线数据确定评价的28％的实验室参数可能与HVRR不同。纵向数据分析确定了1）阈值，其中13个具有高于具有比阈值低于阈值更大可变性的受试者的受试者，并且2）计算预期的上限（X基线）对实验室参数。例如，取决于糖尿病的个体，预期基线的丙氨酸氨基转移酶的1.8- 2.6 X基线值。结论：对于糖尿病患者的临床试验可能与HVRR有可能不同的实验室参数并不罕见，并且测定这些实验室生物标志物中的13个X基基线标准。这表明在修改目前的CTCAE级1级标准时应考虑> 1.5-3.0 X基线的标准，应该进一步调查，因为当前标准检测到该群体中的太多假阳性信号。

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