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深入探究制药“流水线”:研究性药物、临床试验及行业优先事项。

Peering into the pharmaceutical "pipeline": investigational drugs, clinical trials, and industry priorities.

作者信息

Fisher Jill A, Cottingham Marci D, Kalbaugh Corey A

机构信息

Department of Social Medicine, University of North Carolina at Chapel Hill, 333E MacNider Hall, CB #7240, Chapel Hill, NC 27599-7240, USA.

Department of Social Medicine, University of North Carolina at Chapel Hill, 324 MacNider Hall, CB #7240, Chapel Hill, NC 27599-7240, USA.

出版信息

Soc Sci Med. 2015 Apr;131:322-30. doi: 10.1016/j.socscimed.2014.08.023. Epub 2014 Aug 19.

Abstract

In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry's investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding--and often problematic--role of pharmaceuticals in society. To access the pharmaceutical industry's pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2477 different drugs in 4182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline was being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered.

摘要

尽管关于药物化的文献越来越多,但对于制药行业在研发(R&D)方面的投资却知之甚少。有关正在研发的药物的信息可以为现有案例研究提供重要背景,这些案例研究详细说明了药物在社会中不断扩大且往往存在问题的作用。为了了解制药行业的研发流程,我们构建了一个药物数据库,该数据库涵盖了制药公司在五年期间(2006年7月至2011年6月)报告启动临床试验的药物,共涉及4182项临床试验中的2477种不同药物。比较针对高收入国家和低收入国家疾病的在研药物,我们发现针对高收入国家普遍存在疾病的药物数量比针对低收入国家普遍存在疾病的药物数量高3.46倍。我们还发现,在研药物中数量最多的是用于治疗癌症的药物(26.2%)。通过药物化的视角来解读我们的研究结果,我们说明了研究整个药物研发流程如何提供有关药物化模式的重要信息,而这些信息在仅考虑已上市药物时是不可见的。

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