Merck Research Laboratories, Safety Assessment, West Point, Pennsylvania, USA.
Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10.
Application of any new biomarker to support safety-related decisions during regulated phases of drug development requires provision of a substantial data set that critically assesses analytical and biological performance of that biomarker. Such an approach enables stakeholders from industry and regulatory bodies to objectively evaluate whether superior standards of performance have been met and whether specific claims of fit-for-purpose use are supported. It is therefore important during the biomarker evaluation process that stakeholders seek agreement on which critical experiments are needed to test that a biomarker meets specific performance claims, how new biomarker and traditional comparators will be measured and how the resulting data will be merged, analyzed and interpreted.
应用任何新的生物标志物来支持药物开发监管阶段的安全性相关决策，都需要提供一个大量数据集，该数据集需要对该生物标志物的分析和生物学性能进行严格评估。这种方法使来自行业和监管机构的利益相关者能够客观地评估是否达到了更高的性能标准，以及是否支持特定的用途适用性主张。因此，在生物标志物评估过程中，利益相关者应该就需要进行哪些关键实验来测试生物标志物是否符合特定的性能要求达成一致意见，如何测量新的生物标志物和传统的对照物，以及如何合并、分析和解释由此产生的数据。
