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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June 2005


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


Draft Final Report


Prepared for


Office of Technology Transfer

National Institutes of Health

6011 Executive Blvd., Suite 325

Rockville, MD 20852


Prepared by


Submitted by

Sujha Subramanian

Michael Gallagher

Jeffrey Petrusa

Caren Kramer


RTI International

411 Waverley Oaks Road, Suite 330

Waltham, MA 02452-8414


RTI Project Number 09290



EVALUATION OF THE HEALTH AND RESEARCH OUTCOMES OF TECHNOLOGIES LICENSED BY THE NATIONAL INSTITUTES OF HEALTH


Second Draft Report on Tools and Metrics


by Sujha Subramanian, Ph.D.

Michael Gallagher, Ph.D.

Jeffrey Petrusa, B.A.

Caren Kramer, B.A.


RTI Scientific Reviewer: Kathleen N. Lohr, Ph.D.


RTI International*


June 2005


This project was funded by the National Institutes of Health. The statements contained in this report are solely those of the authors and do not necessarily reflect the views or policies of the National Institutes of Health. RTI assumes responsibility for the accuracy and completeness of the information contained in this report.


CONTENTS

SECTION 1
BACKGROUND AND OBJECTIVES 1

SECTION 1
BACKGROUND AND OBJECTIVES 1

SECTION 2
APPROACH AND METHODS 3

SECTION 2
APPROACH AND METHODS 3

2.1 Overview of Approach 3

2.2 Measurement of Impact on Health Outcomes 4

2.3 Literature Review Methodology 4

2.3.1 Framework Development 4

2.3.2 Methods, Metrics and Tools/Data Sources for Assessing Effectiveness 5

2.4 Grouping of products made using NIH technologies 6

SECTION 3
FRAMEWORK AND GROUPING OF TECHNOLOGIES 8

SECTION 3
FRAMEWORK AND GROUPING OF TECHNOLOGIES 8

3.1 “Use of Technology” Framework 8

3.2 Preliminary Review and Grouping of Products made using NIH technologies 12

Phase I – Preliminary Review 12

Phase II – Investigation of selected technologies 12

Phase III – NIH Review and secondary analysis 12

Bacillus Anthracis Protective Protein (target identification/target validation – protein) 12

CYP450 AmpliChip Microarry (clinical application/clinical screening – screening diagnostic) 12

Human Cytochrome P450 cDNAs (CYP450) (drug development/lead optimization - protein) 12

Laser Capture Microdissection (LCM) (target identification/target validation – device) 12

Rabbit Anti-Squid Kinesin Light Chain (generic scientific advancement/basic research –research reagent) 12

Vitravene (clinical application/treatment – HIV/AIDS drug) 12

SECTION 4
METHODS AND METRICS FOR RESEARCH ACTIVITY 16

SECTION 4
METHODS AND METRICS FOR RESEARCH ACTIVITY 16

4.1 Framework for Assessing Effectiveness 16

4.2 Systematic Review of Methods 17

4.3 Implication for Assessing Effectiveness of Research Tools 24

4.4 Metrics for Research Activities using Secondary Data Sources 24

4.4.1 Usefulness/Adoption of Technology 26

4.4.2 Research Advancement 26

4.4.3 Process Optimization 33

SECTION 5
METHODS AND METRICS FOR CLINICAL APPLICATIONS 37

SECTION 5
METHODS AND METRICS FOR CLINICAL APPLICATIONS 37

5.1 Framework for Assessing Effectiveness of Clinical Applications 37

5.2 Metrics for Quantifying Effectiveness 39

5.2.1 Metrics for Vaccines 41

5.2.2 Metrics for Screening and Diagnostic Tests 43

5.2.3 Metrics for Treatments 43

5.2.4 Metrics for Rehabilitation 47

5.3 Implication for products made using NIH technologies 48

SECTION 6
REVIEW OF DATA SOURCES 55

SECTION 6
REVIEW OF DATA SOURCES 55

6.1 Primary Data Collection 55

6.2 Secondary Data Analysis 59

6.3 Comparison of Data Sources 65

6.4 Detailed Review of Health Care Secondary Databases 68

6.4.1 Review of Databases 68

6.4.2 Administrative Databases 77

SECTION 7
PILOT TESTS 79

SECTION 7
PILOT TESTS 79

7.1 Overview 79

7.2 Criteria for Selecting Pilot Tests 79

7.3 Approach and Process for Performing Pilot Test 80

7.4 Summary of Findings 85

7.4.1 Experience with Primary Data Collection 85

7.4.2 OTT Licensing Specialists 86

7.4.3 NIH Inventors 86

7.4.4 Licensee Companies 87

7.5 Experience with Use of Secondary Data Sources 90

7.5.1 Literature Review and Background Research 90

7.5.2 Literature Review and Citation Analysis 93

7.5.3 Patent Databases 94

7.5.4 Utilization/Sales Data Sources 96

7.5.5 Health Care Databases 97

7.6 Pilot Fact Sheets and Level of Effort 97

7.7 Lessons Learned 97

SECTION 8
RECOMMENDATIONS AND FUTURE RESEARCH 99

SECTION 8
RECOMMENDATIONS AND FUTURE RESEARCH 99

8.1 Summary of Key Pilot Test Findings and Expert Review 99

8.2 Specific Recommendations and Future Research 101

REFERENCES 105

REFERENCES 105

APPENDIX A
INTERVIEW GUIDE TO ASSESS TECHNOLOGY ADOPTION 115

APPENDIX A
INTERVIEW GUIDE TO ASSESS TECHNOLOGY ADOPTION 115

APPENDIX A 116

APPENDIX B
WEB-BASED QUESTIONNAIRE ON ADOTPION BARRIERS 118

APPENDIX B
WEB-BASED QUESTIONNAIRE ON ADOTPION BARRIERS 118

APPENDIX B 119

APPENDIX C
QUESTIONNAIRE TO COLLECT CLINICAL ENDPOINTS
AND RESOURCE USE INFORMATION 125

APPENDIX C
QUESTIONNAIRE TO COLLECT CLINICAL ENDPOINTS
AND RESOURCE USE INFORMATION 125

APPENDIX C 126

APPENDIX D
STEPS IN SURVEY-BASED STATISTICAL STUDIES 128

APPENDIX D
STEPS IN SURVEY-BASED STATISTICAL STUDIES 128

APPENDIX D 129

APPENDIX E
PILOT ASSESSMENT OF SECONDARY DATA SOURCES AVAILABLE FOR EVALUATING RESEARCH TOOLS 130

APPENDIX E
PILOT ASSESSMENT OF SECONDARY DATA SOURCES AVAILABLE FOR EVALUATING RESEARCH TOOLS 130

APPENDIX E 131

APPENDIX F
PILOT ASSESSMENT OF SECONDARY DATA SOURCES AVAILABLE FOR EVALUATING CLINICAL APPLICATIONS 133

APPENDIX F
PILOT ASSESSMENT OF SECONDARY DATA SOURCES AVAILABLE FOR EVALUATING CLINICAL APPLICATIONS 133

APPENDIX F 134

APPENDIX G
INCORPORATION HEALTH RELATED QUALITY OF LIFE INSTRUMENTS IN CANCER CLINICAL TRIALS 136

APPENDIX G
INCORPORATION HEALTH RELATED QUALITY OF LIFE INSTRUMENTS IN CANCER CLINICAL TRIALS 136

APPENDIX G 137

APPENDIX H
PILOT STUDY QUESTIONNAIRES 139

APPENDIX H
PILOT STUDY QUESTIONNAIRES 139

APPENDIX H 140

Pilot Study Questionnaires 140

APPENDIX I
INTERVIEW NOTES 148

APPENDIX I
INTERVIEW NOTES 148

APPENDIX J
PILOT ASSESSMENT OF SECONDARY DATA SOURCES AVAILABLE FOR EVALUATION OF NIH-LICENSED TECHNOLOGIES 177

APPENDIX J
PILOT ASSESSMENT OF SECONDARY DATA SOURCES AVAILABLE FOR EVALUATION OF NIH-LICENSED TECHNOLOGIES 177

APPENDIX K
SELECTED ABSTRACTS FROM PILOT TEXT LITERATURE REVIEW 198

APPENDIX K
SELECTED ABSTRACTS FROM PILOT TEXT LITERATURE REVIEW 198

APPENDIX L
EXPERTS CONSULTED 215

APPENDIX L
EXPERTS CONSULTED 215


List of Tables

Table 1. Framework of Basic Research, Drug Development and Clinical Application 10

Table 2. Draft Crosswalk of the “Use of Technology” Framework and NIH Product Categories - Unique Primary Assignment 14

Table 3. Draft Crosswalk of the “Use of Technology” Framework and NIH Product Categories - Multiple Assignment 15

Table 4. Comparison of Methods to Assess Effectiveness of Research Activity 25

Table 5. Potential Metrics to Assess Impacts of Research Activities from Secondary Data Sources 27

Table 6. Potential Metrics to Assess Impacts of Research Activities using Primary Data Sources 35

Table 7. Efficacy versus Effectiveness for Technology Assessment 37

Table 8. Metrics for Screening and Diagnostic Tests 44

Table 9. Crosswalk of Metrics by Use of Technology 49

Table 10. Data Sources for Measuring Public Health Impacts Worldwide 53

Table 11. Sources and Search Engines for Performing Systematic Review of the Literature 62

Table 12. Examples of Databases RTI Staff Have Expertise in Acquiring and Analyzing 63

United States 63

Table 13. Comparison of Available Data Sources 66

Table 14. Review of Health Care Secondary Data Sources 69

Table 15. Technologies Selected for Pilot Test 80

Table 16. Pilot Tests: Papers Consulted 81

Table 17. Results from MEDLINE Search for Clinical Applications 84

Table 18. Pilot Contacts 87

Table 19. Information Obtained and Relevant Metrics from Primary Data Collection 90

Table 20. Secondary Data Sources 91

Table 21. Summary of Patent Citation Searches 96

Table 22. Resources per Pilot Test 98



List of Figures

Figure 1. Direct and Indirect Impacts on Health Outcomes 4

Figure 2. Drug and Device Development Processes 9

Figure 3. Schematic model for assessing effectiveness of biomedical technology transfer 16

Figure 4. Selecting and Quantifying Metrics/Methods for Research Tools 28

Figure 5. Schematic Model of the Process by Which NIH Technology
Transfer Results in Health Impacts 39

Figure 6. Selecting and Quantifying Metrics/Methods for Vaccines 42

Figure 7. Hierarchical Sequence for Diagnostic Tests 43

Figure 8. Selecting and Quantifying Metrics/Methods for Screening/Diagnostic 45

Figure 9. Selecting and Quantifying Metrics/Methods for Treatments 46

Figure 10. Illustration of Technology Adoption 52


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