Collaborative Research: TLS: An Experimental Producer Price Index for Clinical Trials

项目描述：本研究项目研究构建临床试验价格指数的可行性，临床试验是医疗保健研发的重要组成部分。 增加医疗研究开发经费是重要的政策课题，但如果不知道经费的增加是不是由于生物医学研究的投入价格的变化，而不是由于研究数量的变化，就很难对经费的变化进行评价。知识产权本课题构建了将总经费的增长分解为价格和数量的“价格平减指数”。 这些价格指数中很少有专门为科学研究而编制的，尤其是因为研发活动往往具有高度的异质性，因此很难进行有意义的年度比较或不同背景下的比较。 足够详细的数据使得有可能进行价格比较，保持恒定的因素，如临床开发阶段，治疗领域和患者数量，并控制与不同试验设计相关的复杂性和工作负担，使用的方法学“享乐价格分析”已经在许多领域得到了很好的建立，如构建IT产品的平减指数，但以前没有应用于科学研究活动。 这些价格指数，结合在公共注册中心（如clinicaltrials.gov）公布的临床试验活动数据，可以构建按州、国家和研发人员类型划分的临床试验支出的广泛估计。 更广泛的影响。沿着临床研究价格演变的证据，本项目揭示了一些与将研发投资纳入国民收入账户相关的方法学问题，并为围绕美国研发的“外包”和“离岸”以及美国医学研究机构的全球竞争力的重要政策辩论提供了信息。 临床试验越来越多地在传统的美国学术医疗中心之外进行，在医生办公室，诊所和提供商网络以及专门的营利性实体。 此外，试验已变得越来越全球化，一个单一的协议收集来自许多不同国家的网站的数据。 临床试验的这些新特征是研发活动在不同地区、不同参与者和不同机构之间的分布正在发生更广泛变化的一个例子。 本研究项目有助于更好地理解这一现象背后的经济力量。这种方法可以被经济研究所和其他机构用于估算研究开发对真实的和名义国内生产总值的影响，即使是在国家或地区一级，这是很难用现有数据做到的。

Project Description.This research project studies the feasibility of constructing price indexes specifically for clinical trials, an important component of healthcare R&D. Increasing health care R&D spending is an important policy issue, but changes in expenditure are very difficult to evaluate without knowing whether these increases are due to changes in the prices of inputs to biomedical research, as opposed to changes in the quantity of research being performed.Intellectual MeritThe project constructs a "price deflator" that decomposes growth in total expenditure into price and quantity components. Very few of these price indexes have been constructed specifically for scientific research, not least because R&D activities tend to be highly heterogeneous, and therefore difficult to compare meaningfully year-to-year or across different contexts. Sufficiently detailed data make it possible both to make price comparisons that hold constant factors such as the stage of clinical development, therapeutic area, and number of patients, and to control for the complexity and work burden associated with different trial designs, The methodology that is used "hedonic price analysis" has been well-established in many areas, such as constructing deflators for IT products, but not has not previously been applied to scientific research activity. These price indexes, combined with data on clinical trial activity published in public registries such as clinicaltrials.gov, allow the construction of broad-based estimates of clinical trial expenditures broken out by state, country, and type of R&D performer. Broader Impact.Along with evidence on the evolution of the price of clinical research, this project sheds light on a number of methodological issues relating to the integration of R&D investment into the national income accounts, and informs important policy debates surrounding the "outsourcing" and "offshoring" of US R&D, and the global competitiveness of American medical research establishments. Clinical trials are increasingly being performed outside traditional US academic medical centers, at physicians' offices, clinics, and provider networks, as well as by specialized for-profit entities. Moreover, trials have become increasingly global, with a single protocol collecting data from sites in many different countries. These new features of clinical trials are one example of broader changes under way in the distribution of R&D activity across geographies, actors, and institutions. This research project helps develop a better understanding of the economic forces underlying this phenomenon.This approach can be used by BEA and other agencies in developing estimates of the impact of R&D on real and nominal gross domestic product, even at the state or regional level, which is very difficult to do with current data.