Tracking the pharmaceutical pipeline: clinical trials and global disease burden.
Tracking the pharmaceutical pipeline: clinical trials and global disease burden.
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跟踪药品管道：临床试验和全球疾病负担。
DOI：
10.1111/cts.12163
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发表时间：
2014
期刊：
影响因子：
--
通讯作者：
Fisher,JillA
中科院分区：
文献类型：
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作者：
Cottingham,MarciD;Kalbaugh,CoreyA;Fisher,JillA
关于药物研发（R&D）的综合数据倾向于检查III期试验。因此，很少有关于临床开发早期阶段可能失败的研究药物的已发表数据。研发与疾病负担的对应程度也不清楚。我们使用来自行业出版物的数据来跟踪药品管道，这些出版物提供了有关行业申办的临床试验的未报告信息。该样本包括4，182项临床试验中的2，477种独特药物实体。大部分药物针对肿瘤（26.20%）、神经系统疾病/感觉器官疾病（13.48%）、传染病和寄生虫病（10.5%）以及内分泌、代谢、营养和免疫疾病（9.45%）。不到6%的药物针对循环系统疾病，这是全球死亡率最普遍的原因。详细介绍了药物管道，我们的研究结果表明，药物开发并不能充分解决全球疾病负担。未来需要对I期和II期临床试验报告不足的细节进行研究，以了解该行业的运作方式以及其资源分配如何与全球健康问题相匹配。
Aggregate data about pharmaceutical research and development (R&D) tend to examine Phase III trials. Hence, there are few published data about investigational drugs in earlier phases of clinical development that might fail. It is also unclear how well R&D corresponds to disease burden. We track the pharmaceutical pipeline using data from industry publications that provide otherwise unreported information about industry‐sponsored clinical trials. The sample includes 2,477 unique drug entities in 4,182 clinical trials. The majority of drugs targeted neoplasms (26.20%), neurological diseases/diseases of the sense organs (13.48%), infectious and parasitic diseases (10.5%), and endocrine, metabolic, nutrition, and immunity disorders (9.45%). Less than 6% of drugs targeted diseases of the circulatory system, which represent the most prevalent causes of global mortality. Detailing the pharmaceutical pipeline, our findings suggest that pharmaceutical development does not adequately address global disease burden. Future research on the under‐reported details of Phase I and II clinical trials is needed to understand how the industry operates and how its resource‐allocation matches global health concerns.