Abstract：
UNASSIGNED: There is an urgent, persistent, need for better biomarkers in clinical drug development. More informative biomarkers can increase the likelihood of drug advancement or approval, and implementing biomarkers increases the success rate in drug development. Biomarkers may guide decisions and allow resources to be directed to the projects most likely to succeed. However, biomarkers that are validated to high standards are needed, reflecting biological and pathological processes accurately. Such biomarkers are needed to develop treatments faster, and to improve and guide clinical trial design by selecting and de-selecting patients.
UNASSIGNED: In this review based on the authors\' previous published experience and interaction with pharmaceutical- and biomarker stakeholders, we highlight the use and value of biomarkers in clinical development according to the BEST guidelines. We highlight the value of 3 types of biomarkers that may provide optimal value to stakeholders: diagnostic, prognostic and pharmacodynamic biomarkers.
UNASSIGNED: A more appropriate clinical trial design, increasing the ratio between benefits and side effects, may come from a more tailored biomarker-approach identifying suitable molecular endotypes of patients to treat.
UNASSIGNED: Biomarkers may guide drug developers in selecting the optimal projects to progress, when designing clinical studies and development paths. Biomarkers may aid in the diagnosis and prognostic assessment of patients and assist in matching the molecular endotype to the selected treatment, which improves the success rate of clinical development progression. The aim of this paper is to provide a comprehensive ideation framework for how to utilize biomarkers in clinical development, with a focus on utility for patients, payers and drug developers.
UNASSIGNED: In this review based on the authors\' previous published experience and interaction with pharmaceutical- and biomarker stakeholders, we highlight the use and value of biomarkers in clinical development according to the BEST guidelines. We highlight the value of 3 types of biomarkers that may provide optimal value to stakeholders: diagnostic, prognostic and pharmacodynamic biomarkers.
UNASSIGNED: A more appropriate clinical trial design, increasing the ratio between benefits and side effects, may come from a more tailored biomarker-approach identifying suitable molecular endotypes of patients to treat.
UNASSIGNED: Biomarkers may guide drug developers in selecting the optimal projects to progress, when designing clinical studies and development paths. Biomarkers may aid in the diagnosis and prognostic assessment of patients and assist in matching the molecular endotype to the selected treatment, which improves the success rate of clinical development progression. The aim of this paper is to provide a comprehensive ideation framework for how to utilize biomarkers in clinical development, with a focus on utility for patients, payers and drug developers.
摘要：
介绍有一个紧急的,持久性,在临床药物开发中需要更好的生物标志物。更多的信息生物标志物可以增加药物进步或批准的可能性，实施生物标志物提高了药物开发的成功率。生物标志物可以指导决策，并允许资源被引导到最有可能成功的项目。然而,需要经过高标准验证的生物标志物，准确反映生物和病理过程。需要这样的生物标志物来更快地开发治疗方法，并通过选择和取消选择患者来改进和指导临床试验设计。方法在这篇综述中，基于作者先前发表的经验和与药物和生物标志物利益相关者的相互作用，根据BEST指南,我们强调了生物标志物在临床开发中的用途和价值.我们强调了3种类型的生物标志物的价值，这些生物标志物可能为利益相关者提供最优价值：诊断，预后和药效学生物标志物。结果更合适的临床试验设计，增加益处和副作用之间的比例，可能来自更量身定制的生物标志物-方法，确定患者的合适分子内生型来治疗。讨论生物标志物可以指导药物开发商选择最佳的项目进行，在设计临床研究和发展路径时。生物标志物可能有助于患者的诊断和预后评估，并有助于将分子内生型与所选治疗相匹配。提高了临床发展进展的成功率。本文的目的是为如何在临床开发中利用生物标志物提供一个全面的构想框架。专注于患者的效用，付款人和药物开发商。
