Evaluation of the Health and Research Outcomes of Technologies Licensed by the National Institutes of Health




НазваниеEvaluation of the Health and Research Outcomes of Technologies Licensed by the National Institutes of Health
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Дата17.10.2012
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SECTION 1
BACKGROUND AND OBJECTIVES


The National Institutes of Health (NIH) conducts and supports biomedical research to improve the public health. The continued development and commercialization of NIH technological innovations by the private sector will improve health care, as these technologies reduce the incidence and prevalence of disease, improve quality of life, and decrease mortality. Application of these technologies will also influence resources used, insofar as newer methods for providing health care supplant current methods.

Evaluating the effectiveness and health benefits of biomedical technologies, especially early-stage research tools, is a considerable challenge and a complex endeavor (Bozeman, 2000: Wang et al., 2003). Past NIH efforts have been based largely on measuring effectiveness of technology transfer activities using outputs such as number of patents and licenses or the amount of royalty generated. These do not measure the outcome or public health impact of these activities and therefore do not provide an adequate assessment of the benefits of NIH funded technologies. NIH has also performed five case studies. Case studies involve subjective interpretation and are time consuming and expensive to perform. Therefore, the case study methodology is not a practical approach to assess the more than 200 products made using NIH technologies.

To support NIH’s mission, the objective of this project is to develop and demonstrate a method for estimating the public health benefits of products made using NIH technologies licensed to the private sector. The product categories of interest include drugs/vaccines, diagnostics, medical devices, and research tools. Research tools include a broad range of products from reagents to methods that revolutionize research activities. The impact of products made using NIH technologies will be assessed by measuring the net benefits of the final products that incorporate them. The measures analyzed will include metrics associated with research advancement and those related to health outcomes. The health outcomes will capture both the benefits and harms of the prevention, diagnosis, and treatment of diseases. In addition, changes in the utilization of health care resources resulting from the use of the products developed from NIH technology will be assessed. Benefits captured in terms of cost or economic impacts (e.g., increase in national income) will not be included as assessment measures and are therefore not addressed in this report.

In this report we describe the framework that will be used to formulate the metrics and tools to assess the products made using NIH technologies. In addition, we present results from the review of the literature on potential metrics and tools that can be used to assess the effectiveness of the products made using NIH technologies. In Section 2, the methodology approach and details on the literature review are described. In Section 3, the framework and grouping of the products made using NIH technologies is presented. The syntheses and recommendations from the literature review on methods are presented for research tools and clinical applications in Section 4 and 5 respectively. In Section 6, we provide a thorough discussion of the available data sources. In Section 7, we describe the approach adopted to perform pilot tests on 8 selected products and a detailed listing of the findings is provided. In Section 8, we summarize the key findings based on both pilot tests and expert reviews, and provide recommendations and areas for future research.

SECTION 2
APPROACH AND METHODS


Measuring the benefits of research and development initiatives is a significant challenge that is acknowledged widely (Zeckhauser, 1996; Feller et al., 2002). A frequent response to identifying methods and tools to perform such assessments are met with responses such as “it is hard to so. How do you put a value on information?” (Feller et al., 2002, p.471). The assessment of the effectiveness of the products made using NIH technologies is an additional challenge given the large volume and emphasis on research tools that are generally used in the process of developing commercialized products that result in health benefits. The NIH Working Group on Research Tools concluded that “the value of research tools is difficult to assess and varies greatly from one tool to the next and from one use to the next” (NIH, 1998, p.2). Given this challenge, NIH and RTI International (RTI) have developed a comprehensive approach to identify methods, tools and metrics to assess the effectiveness of NIH technology.

The term “research tool” embraces a full range of tools that scientists use in the laboratory, including cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines. There is some confusion as to whether research tools should incorporate therapeutic compounds as these are seen as “end products” (NIH, 1998). It is not always possible to identify the difference between research tool and end products early in the life cycle of the technology and to avoid confusion we have adopted the term “research activity” to encompass all basic and applied research generated by the NIH.
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