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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3.1 “Use of Technology” Framework


There are three ways to describe and categorize health care technologies (adapted from Goodman, 1998):

  1. Material Nature – These are broad groupings of practical application, such as research tools, drugs, devices, medical and surgical procedures, support systems, and organization and managerial systems.

  2. Purpose (Use) – Technologies can also be grouped according to their use. For clinical application the groupings are prevention, screening, diagnosis, treatment and rehabilitation.

  3. Stage of Diffusion – Technologies can be at different stages of adoption and maturity including conception, experimental, investigational, established and obsolete.

Not all technologies neatly fall into one category. For instance, “boundary crossing” technologies can combine characteristics of both drugs and devices (e.g. drug-coated stents, implantable drug infusion pumps). Several tests, such as mammograms, serve as both screening and diagnostic tests. Technologies also do not follow a neat linear path of diffusion and a technology that is considered obsolete may reappear (Reiser, 1994).

Of the three potential groupings of technologies described above, purpose or use of technology is the categorization that is linked to the health benefits of the technologies. The final users of health technologies and society as a whole values health technologies for their practical application (IOM, 1985) and do not necessary distinguish them by material nature or diffusion stage. For instance, prevention leads to a different set of health benefits (avoidance of disease) compared to treatment (cure for disease). Therefore the recommendation is to build the framework for assessing the products made using NIH technologies based on the “use of technology.” In Table 1, a framework based on use of the technology from basic research to clinical application is provided. The framework largely reflects the drug discovery and development pathways because the drug discovery process is generally a more complex process than developing devices and other types of products. Using the drug discovery pathway therefore provides a comprehensive framework for the assessment of the products made using NIH technologies. The device development process including design (create computer model of product), development (build prototype), animal testing (pre-clinical testing in animal models), clinical development (human trials (FDA)) and clinical application (use in patient care) can be incorporated into the overall drug discovery framework (Figure 2).

Figure 2. Drug and Device Development Processes



As shown in Table 1, there are 14 categories comprised of 1st Tier and 2nd Tier classifications. First Tier classifications include general research, target identification, drug development, and clinical application. Second Tier applications provide further disaggregation. For example, target identification is segmented into three 2nd Tier classifications, genomics, cell signaling, and target validation. The Second Tier classifications are identified in this framework in order to ensure that metrics are assessed in relation to the use of the technology. For instance,

Table 1. Framework of Basic Research, Drug Development and Clinical Application



Categories
Description

Applicable to Development of…

General Research

Basic Research

Provide fundamental science base on which to build better technologies to improve public health. This research is performed without specific applications in mind.

Drugs

Devices

Enabling technologies

Build products that can be used to improve the process of performing biomedical research (decrease time, reduce cost).

Drugs

Devices

Target Identification


Target Discovery

(e.g., Genomics, Cellular Signaling)

Find proteins or disease models that can be used to alter the outcome of diseases. This could involve the use of genomics to build knowledge of the genes involved in diseases, disease pathways, and drug- response sites and cellular signaling assessment to study the mechanisms of signaling pathways including identifying the molecules and synthesizing detailed data into sets of interacting models.

Drugs

Target Validation

Assess whether proteins or disease models discovered will when perturbed by a drug affect the outcome of the disease (i.e. potential to be a therapeutic target).

Drugs

Drug Development

Assay Development

Build a laboratory method to identify molecules that can perturb the target.

Drugs

Screening

Test a collection of molecules to identify the ones that have activity.

Drugs

Lead Optimization

Extensively optimize molecules for pharmaceutically-relevant activity.

Drugs

Pre-clinical

Test molecules in animal models of relevant disease.

Drugs; Devices

Clinical Development: Human clinical trials and FDA approval

Drugs; Devices

Clinical Application

Prevention

Used to protect against acquiring potential disease or reduce severity of the disease (e.g. childhood immunizations, influenza vaccine).




Screening

Tests intended to detect a disease, abnormality, or associated risk factors in asymptomatic people (e.g., Pap smear, tuberculin test, mammography, serum cholesterol testing).




Diagnosis

Tests that identify the nature and extent of the disease. Many tests that are used for screening are also used for diagnosis (e.g. mammography).




Treatment

Interventions that improve a patient’s health outcomes and overall well-being or maintain health status and provide palliation (e.g. HIV medications, chemotherapy agents).




Rehabilitation

Technologies that are used to restore, maintain or improve mental and physical function (e.g. devices used to assist in ambulation, muscle relaxants).




the benefits of a research tool in target validation would be very different from one in lead optimization.
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