A risky business: the detection of adverse drug reactions in clinical trials and post-marketing exercises
A risky business: the detection of adverse drug reactions in clinical trials and post-marketing exercises
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DOI：
10.1016/s0277-9536(01)00183-6
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发表时间：
2002-08-01
影响因子：
5.4
通讯作者：
Corrigan, OP
中科院分区：
文献类型：
--
作者：
Corrigan, OP
虽然流行病学家、药理学家和医生广泛承认药物不良反应（ADR）发生的频率相当高，但在医学社会学领域，药物引起的风险目前几乎没有受到严格的关注。本文探讨了这个医学科学的“黑匣子”，提出了一个全面的认识论和政治过程中发挥作用，在检测药品不良反应。通过关注药理学家、流行病学家和其他在该领域工作的人所产生的文献，本文研究了在临床药物试验期间和以后用于识别和计算ADR的各种技术和方法。虽然与药物消费相关的风险通常被视为一种可科学计算的客观现象，但在确定药物是否导致不良事件时，因果机制的归属是一个高度偶然的社会过程，通常涉及复杂的临床判断。在临床试验期间，变量是受控的，并实施排除，以满足科学协议的要求。这些排斥性做法意味着，在试验过程中，妇女和老年人等主要患者群体的代表性往往不足。在授予药品许可证时，ADR风险存在许多不确定性。一旦一种药物被广泛使用，一个更全面的风险概况可能开始出现。然而，考虑到在日常使用中，药物可以与其他药物，酒精甚至某些食物相互作用，并且药物反应可以模拟它们应该治疗的疾病，区分“信号”和“噪音”是一个混乱的，偶然的复杂过程。(C)2002爱思唯尔科技有限公司。保留所有权利。
While it is widely acknowledged by epidemiologists, pharmacologists and physicians that adverse drug reactions (ADRs) occur with considerable frequency, within the realm of medical sociology, drug-induced risk currently receives little critical attention. This paper looks into this medical scientific 'black box' to present a comprehensive account of the epistemological and political processes at play in the detection of ADRs. By focusing on the literature generated by pharmacologists, epidemiologists and others working in the field, this paper examines the various techniques and methods used to identify and calculate ADRs both during clinical drug trials and beyond. Although risk associated with drug consumption is often presented as a scientifically calculable objective phenomenon, the attribution of causal mechanisms in determining whether the drug has caused an adverse event is a highly contingent social process, often involving complex clinical judgements. During clinical trials, variables are controlled and exclusions are imposed in order to fulfil scientific protocol requirements. These exclusionary practices mean that major patient population groups such as women and the elderly are often underrepresented during the trial process. At the time a drug product license is granted many uncertainties exist about the risk of ADRs. Once a drug is in widespread use, a more comprehensive profile of risk may begin to emerge. However, given that in everyday use drugs can interact with other drugs, alcohol and even certain foods and that drug reactions can mimic the disease they are supposed to be treating, differentiating between 'signal' and 'noise' is a messy, contingent complex process. (C) 2002 Elsevier Science Ltd. All rights reserved.