Agúndez José A G, Del Barrio Jaime, Padró Teresa, Stephens Camilla, Farré Magí, Andrade Raúl J, Badimon Lina, García-Martín Elena, Vilahur Gemma, Lucena M Isabel
Department of Pharmacology, University of Extremadura Cáceres, Spain.
Front Pharmacol. 2012 Jan 19;3:2. doi: 10.3389/fphar.2012.00002. eCollection 2012.
In this paper we discuss the consensus view on the use of qualifying biomarkers in drug safety, raised within the frame of the XXIV meeting of the Spanish Society of Clinical Pharmacology held in Málaga (Spain) in October, 2011. The widespread use of biomarkers as surrogate endpoints is a goal that scientists have long been pursuing. Thirty years ago, when molecular pharmacogenomics evolved, we anticipated that these genetic biomarkers would soon obviate the routine use of drug therapies in a way that patients should adapt to the therapy rather than the opposite. This expected revolution in routine clinical practice never took place as quickly nor with the intensity as initially expected. The concerted action of operating multicenter networks holds great promise for future studies to identify biomarkers related to drug toxicity and to provide better insight into the underlying pathogenesis. Today some pharmacogenomic advances are already widely accepted, but pharmacogenomics still needs further development to elaborate more precise algorithms and many barriers to implementing individualized medicine exist. We briefly discuss our view about these barriers and we provide suggestions and areas of focus to advance in the field.
在本文中，我们讨论了于2011年10月在西班牙马拉加举行的西班牙临床药理学会第二十四届会议框架内提出的关于药物安全性中合格生物标志物使用的共识观点。生物标志物作为替代终点的广泛应用是科学家们长期追求的目标。三十年前，当分子药物基因组学发展时，我们曾预计这些基因生物标志物很快会使药物治疗的常规使用变得不再必要，患者应适应治疗，而非相反。然而，这种常规临床实践中预期的革命并未像最初预期的那样迅速且强烈地发生。多中心网络的协同行动对未来研究大有希望，这些研究旨在识别与药物毒性相关的生物标志物，并更深入地了解潜在的发病机制。如今，一些药物基因组学进展已被广泛接受，但药物基因组学仍需进一步发展以制定更精确的算法，并且实施个性化医疗存在许多障碍。我们简要讨论了我们对这些障碍的看法，并提供了在该领域取得进展的建议和重点关注领域。
