Risk Management Principles for Devices and Pharmaceuticals
viii
Table 20-19. Mortality Comparisons Across Treatment Groups -All Cause through
December 31, 1998 (Intent-to-treat)................................................................................300
Table 20-20. Mortality Comparisons Across Treatment Groups -Any Cancer Listed on the
Death Certificate through December 31, 1997 (Intent-to-treat).....................................301
Table 20-21. Mortality Comparisons Across Treatment Groups -Lung Cancer Listed on the
Death Certificate through December 31, 1997 (Intent-to-treat).....................................302
Table 20-22. Accountability of the 42 Patients with Lung Cancer Reported in the Clinical
Database..........................................................................................................................303
Table 20-23. Analysis of Lung Cancer Mortality through 1997 in Current or Previous Smokers........303
Table 20-24. Mortality Comparisons Across Treatment Groups -Lung Cancer Listed on the
Death Certificate Through December 31, 1997 Among Patients Without a Diagnosis
of Lung Cancer, according to the Clinical Database (Intent-to-treat).............................304
Table 21-1. The Innovation (Desired Risk Mitigation Behavior). ......................................................320
Table 21-2. Communication Channels. ..............................................................................................322
Table 21-3. Time and the Adoption Curve. .......................................................................................323
Table 21-4. The Social System. ...........................................................................................................325
Table 22-1. Components of the Proposed Risk Minimization Program for Product C in the EU.. ...336
Table 22-2. Evaluation Dimensions, Quantitative and Qualitative Measures, and Corresponding
Data Sources for the Mixed Methods Evaluation of the RM Program for Product C
Using the RE-AIM QuEST Framework.........................................................................338
Index......................................................................................................................................................361
viii
Table 20-19. Mortality Comparisons Across Treatment Groups -All Cause through
December 31, 1998 (Intent-to-treat)................................................................................300
Table 20-20. Mortality Comparisons Across Treatment Groups -Any Cancer Listed on the
Death Certificate through December 31, 1997 (Intent-to-treat).....................................301
Table 20-21. Mortality Comparisons Across Treatment Groups -Lung Cancer Listed on the
Death Certificate through December 31, 1997 (Intent-to-treat).....................................302
Table 20-22. Accountability of the 42 Patients with Lung Cancer Reported in the Clinical
Database..........................................................................................................................303
Table 20-23. Analysis of Lung Cancer Mortality through 1997 in Current or Previous Smokers........303
Table 20-24. Mortality Comparisons Across Treatment Groups -Lung Cancer Listed on the
Death Certificate Through December 31, 1997 Among Patients Without a Diagnosis
of Lung Cancer, according to the Clinical Database (Intent-to-treat).............................304
Table 21-1. The Innovation (Desired Risk Mitigation Behavior). ......................................................320
Table 21-2. Communication Channels. ..............................................................................................322
Table 21-3. Time and the Adoption Curve. .......................................................................................323
Table 21-4. The Social System. ...........................................................................................................325
Table 22-1. Components of the Proposed Risk Minimization Program for Product C in the EU.. ...336
Table 22-2. Evaluation Dimensions, Quantitative and Qualitative Measures, and Corresponding
Data Sources for the Mixed Methods Evaluation of the RM Program for Product C
Using the RE-AIM QuEST Framework.........................................................................338
Index......................................................................................................................................................361