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Making the Most of Innovation in Personalised Medicine: An EU Strategy for a Faster Bench to Bedside and Beyond Process
Public Health Genomics ( IF 1.3 ) Pub Date : 2018-01-01 , DOI: 10.1159/000497809
Denis Horgan 1 , Jonathan A Lal 2, 3
Affiliation  

Personalised medicine promises to revolutionise healthcare, with its key goal of providing the right treatment to the right patient at the right time, and thus the potential of improving quality of life and helping to bring down healthcare costs. However, a major problem with broader implementation of personalised medicine is patient access to new drugs, devices and treatments. The fact that a new medicine or innovative product can sometimes take as long as 20 years to get from bench to bedside is not only clearly undesirable but is arguably unacceptable in the 21st century. This paper looks in detail at the issues surrounding development, continued investment, risk factors, testing and approval from both the industry perspective as well as that of the assessor and the decision maker/payer. It becomes clear that there is a lack of working in tandem that results in a double time frame (two times 10 years). This is simply because the key stakeholders, surprisingly, do not synergise their assessments of a new product. As well as causing delays in patient access, this can also affect investment confidence as industry waits too long for approval for its product to reach the market and its subsequent implementation into healthcare. Such a slow process undermines continued investment and contributes to a risk-averse environment, which in turn can have an impact on innovation. The solution appears to be uncomplicated, involving better coordination and collaboration between the different stakeholders working at various stages within the bench-to-bedside timeframe. We take the example of the network of the European Alliance for Personalised Medicine (EAPM) to demonstrate possible solutions using an innovative approach.

中文翻译:

充分利用个性化医疗的创新:欧盟的一项战略,以加快从临床到床边和超越过程的速度

个性化医疗有望彻底改变医疗保健,其主要目标是在正确的时间为正确的患者提供正确的治疗,从而有可能提高生活质量并帮助降低医疗保健成本。然而,更广泛实施个性化医疗的一个主要问题是患者获得新药物、设备和治疗的途径。新药或创新产品有时需要长达 20 年的时间才能从临床试验到床边,这一事实不仅明显不受欢迎,而且在 21 世纪也可以说是不可接受的。本文从行业角度以及评估者和决策者/付款人的角度详细探讨了围绕开发、持续投资、风险因素、测试和批准的问题。很明显,缺乏协同工作导致了双重时间框架(两次 10 年)。这仅仅是因为关键利益相关者出人意料地没有协同他们对新产品的评估。除了导致患者准入延迟外,这还会影响投资信心,因为行业等待其产品进入市场以及随后在医疗保健中的实施的批准时间太长。这种缓慢的过程会破坏持续的投资并助长规避风险的环境,这反过来又会对创新产生影响。该解决方案似乎并不复杂,涉及在从工作台到床边的时间范围内在不同阶段工作的不同利益相关者之间更好的协调和协作。
更新日期:2018-01-01
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