Hayashi K, Masuda S, Kimura H
Graduate School of Pharmaceutical Science, The University of Tokyo, Tokyo, Japan.
Drug Discov Ther. 2012 Apr;6(2):102-7.
The trend of biomarker use in drug interventional clinical studies was analyzed using ClinicalTrials.gov to provide an overview of how biomarkers are used to streamline clinical studies and to examine regional differences. A total of 3,383 clinical study data was analyzed according to phase, region, sponsor, and therapeutic class. The number of clinical studies using biomarkers has been increasing constantly and is dependent on the number of Phase I and II studies. The majority of studies (58.5%) were sponsored by the United States, with the studies being conducted mainly in the sponsor's home region (80.3%). The use of biomarkers was prominent in the oncology area (37.1%). Although current data indicates some bias in the clinical use of biomarkers, it is expected that their use will increase in later phase studies or other therapeutic areas as biomarker development proceeds. In addition, limited regional use of biomarkers may lead to differences in biomarker use in drug development and in combination with political support may result in differences in competitiveness of drug development. Biomarkers would be a powerful tool against deteriorating research and development productivity when used more in appropriate clinical study conditions.
利用ClinicalTrials.gov分析了生物标志物在药物干预临床研究中的使用趋势，以概述生物标志物如何用于简化临床研究并审视区域差异。根据阶段、地区、申办者和治疗类别，共分析了3383项临床研究数据。使用生物标志物的临床研究数量一直在不断增加，且取决于I期和II期研究的数量。大多数研究（58.5%）由美国申办，研究主要在申办者的本国地区进行（80.3%）。生物标志物的使用在肿瘤学领域最为突出（37.1%）。尽管目前的数据表明生物标志物的临床使用存在一些偏差，但预计随着生物标志物开发的推进，其在后期研究或其他治疗领域的使用将会增加。此外，生物标志物在区域内的使用有限可能导致药物开发中生物标志物使用的差异，并且与政策支持相结合可能导致药物开发竞争力的差异。当在适当的临床研究条件下更多地使用生物标志物时，它们将成为应对研发生产力下降的有力工具。
