Private manufacturers' thresholds to invest in comparative effectiveness trials.

Private manufacturers' thresholds to invest in comparative effectiveness trials.
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DOI:
10.2165/11597730-000000000-00000
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发表时间:
2012-10-01
期刊:
影响因子:
4.4
通讯作者:
Meltzer D
Meltzer D
中科院分区:
医学2区
文献类型:
--
作者:
Basu A;Meltzer D

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最近,美国对比较有效性研究(CER)的公共投资热情高涨,使人们的注意力集中在这些公共投资上。然而,很少有人注意到,改变对核证的排减量的公共投资可能会影响私人制造商对核证的排减量的激励,这一直是核证的排减量的主要来源。在这项工作中,基于一个简单的收入最大化的经济框架,我们产生的预测阈值投资CER的私人制造商,比较自己的产品,其竞争对手的头对头试验。我们的分析表明,私人投资CER的动机取决于CER的结果如何影响销售产品的价格和数量,以及在完成CER所需的时间和从CER完成到专利到期的时间内,由此产生的收入变化将累积的持续时间。我们强调的结果是,私人激励可能往往低于公共激励投资于CER,甚至可能是负面的,如果不利的结果的可能性是足够的。我们发现,这些激励措施意味着一些预测模式的核证减排量,以及他们将如何受到影响的变化,在公共融资的核证减排量和核证减排量的方法。例如,这些激励措施意味着,现有专利持有者可能比进入者更不可能对核证的排减量进行投资,对核证的排减量的公共投资可能会排挤类似的私人投资。相比之下,新的核证排减量设计和方法,如贝叶斯适应性试验,可以减少不利结果的事后风险,缩短核证排减量的产生时间,只要这种创新设计的成本不过高,就可能增加核证排减量的预期效益,并可能增加私人对核证排减量的投资。贝叶斯设计方法也自然突出了CER的动态方面,允许更便宜的初始研究来指导未来投资的决策,从而鼓励更多的CER初始投资。然而,我们强调的CER的公共资金和贝叶斯方法的试验设计的潜在影响是否实际上产生了CER的私人投资的变化仍然是一个实证问题。
The recent rush of enthusiasm for public investment in comparative effectiveness research (CER) in the United States has focused attention on these public investments. However, little attention has been given to how changing public investment in CER may affect private manufacturers’ incentives for CER, which has long been a major source of CER. In this work, based on a simple revenue maximizing economic framework, we generate predictions on thresholds to invest in CER for a private manufacturer that compares its own product to its competitor’s in head to head trials. Our analysis shows that private incentives to invest in CER are determined by how the results of CER may affect the price and quantity of the product sold and the duration over which resulting changes in revenue would accrue given the time required to complete CER and the time from the completion of CER to the time of patent expiration. We highlight the result that private incentives may often be less than public incentives to invest in CER and may even be negative if the likelihood of adverse findings is sufficient. We find that these incentives imply a number of predictions about patterns of CER and how they will be affected by changes in public financing of CER and CER methods. For example, these incentives imply that incumbent patent holders may be less likely to invest in CER than entrants and that public investments in CER may crowd out similar private investments. In contrast, newer designs and methods for CER, such as Bayesian adaptive trials, which can reduce ex-post risk of unfavorable results and shorten the time for the production of CER, may increase the expected benefits of CER and may tend to increase private investment in CER as long as the costs of such innovative designs are not excessive. Bayesian approaches to design also naturally highlight the dynamic aspects of CER, allowing less expensive initial studies to guide decisions about future investments and thereby encouraging greater initial investments in CER. However, whether the potential effects we highlight of public funding of CER and of Bayesian approaches to trial design actually produce changes in private investment in CER remains an empirical question.
DOI: 10.1377/hlthaff.24.1.93
发表时间: 2005-01-01
期刊: HEALTH AFFAIRS
影响因子: 9.7
作者:
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DOI: 10.1177/0272989x11412975
发表时间: 2011-11-01
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DOI: 10.2165/11539400-000000000-00000
发表时间: 2010-01-01
期刊: PHARMACOECONOMICS
影响因子: 4.4
作者:
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DOI: 10.1177/0272989x04263162
发表时间: 2004-03-01
影响因子: 3.6
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