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Testing regimes in clinical trials: Evidence from four polio vaccine trajectories

机译:临床试验中的测试方案:四种脊髓灰质炎疫苗轨迹的证据

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This paper highlights distinctive features of a neglected class of economic activity in the domain of medical innovation, namely the creation of testing regimes in clinical trials, asking how their nature might be expected to affect innovation of medical technology. It argues firstly that clinical trials are not simply about passively validating an already well-known technology and verifying its safety. Rather, clinical trials are part of a more active process of learning that allows pharmaceutical innovations to be useful outside the laboratory. It argues secondly that product development can proceed along a number of long and costly paths before a product's behaviour in actual practice becomes clear, which can make selecting between alternative courses of action difficult. Thus, product choice and product development need to go hand-in-hand. To consider these arguments, the paper maps out four trajectories of polio vaccine development, tracing their paths through clinical trials since the 1950s, and describes some of the defining features of testing regimes for medical innovation. These include institutions that integrate knowledge and co-ordinate skills in testing processes, and capabilities for allocating testing resources, managing testability constraints, sharing knowledge and improving commensurability between testing communities.
机译:本文重点介绍了在医疗创新领域中被忽视的一类经济活动的显着特征,即在临床试验中建立测试制度,询问其性质将如何影响医疗技术的创新。首先,它认为临床试验不只是被动地验证一种已经众所周知的技术并验证其安全性。相反,临床试验是更积极的学习过程的一部分,该过程使药物创新可以在实验室外使用。其次,在产品在实际实践中的行为变得清晰之前,产品开发可能会沿着许多漫长而昂贵的道路进行,这会使选择其他行动方案变得困难。因此,产品选择和产品开发需要齐头并进。为了考虑这些论点,本文列出了脊髓灰质炎疫苗开发的四个轨迹,并追溯了自1950年代以来通过临床试验的路径,并描述了医学创新测试制度的一些定义特征。这些机构包括在测试过程中整合知识和协调技能的机构,以及分配测试资源,管理可测试性约束,共享知识以及提高测试社区之间的可比性的能力。

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