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中国药物经济学评价指南
China Pharmacoeconomic Evaluation Guidelines
（征求意见稿）
（The Solicitation Draft）

各部分编写者：
前言：胡善联
上市前药物经济学评价指南：刘国恩、雷海潮、杨莉、单爱莲
上市后药物经济学评价指南：胡善联、李幼平、马进、李焕德、王强
中成药药物经济学评价指南：程晓明、马爱霞、倪健、黄仲义
附录：杨莉

Contents

Part One. Foreword

1. Background and motivation.
2. Objectives to compile the Guidelines
3. Compiling principles
4. Purposes of the Guidelines
5. Life cycle of drug
6. Definition of pre-marketing drug, post-marketing drug and Chinese traditional patent
medicine
7. Contents of the Guidelines
8. Analytic perspective of the Guidelines
9. Application of the Guidelines
10. Criteria and standards of PE evaluation units and staff
11. Organizing work of PE evaluation
12. Managing and operating patterns of the Guidelines

Part Two. Pre-marketing Pharmacoeconomic Evaluation Guidelines

1. Purpose of pre-marketing Pharmacoeconomic Evaluation Guidelines
2. Analytic perspective
3. Analytic methods
4. End-point criteria
5. Research Period
6. Data collection
7. Definition of costs
8. Measurement of costs
9. Measurement of outputs
10. Data analysis
11. Uncertainty
12. Modeling analysis
13. Subgroup analysis
14. Report of methods and outcomes

Part Three. Post-marketing Pharmacoeconomic Evaluation Guidelines

1. Definition of Post-marketing drug
2. Classification of Post-marketing Pharmacoeconomic Evaluation
3. Objectives and purposes
4. System evaluation and evidence classes
5. Evaluation methods
6. Economic evaluation of validity of post-marketing drug
7. Economic evaluation of drug risks and safety in post-marketing drug
8. Choosing of comparator drug
9. Study of modality pattern
10. Definition and measurement of costs
11. End-point events
12. Differences between pre-marketing pharmacoeconomics and post-marketing
pharmacoeconomics
13. Outcome research
14. Pragmatic study
15. Piggy-back study
16. Randomized control clinical trial
17. Unicentral and multi-center study
18. Cohort study
19. Prospective cohort study
20. Retrospective cohort study
21. Before and after study
22. Modeling analysis
23. Bias and its control
24. Drug pricing
25. Budget impact analysis
26. Outcome report

Part Four. Chinese Traditional Patent Medicine Pharmacoeconomic Evaluation Guidelines

1. Objectives
2. Chinese Traditional Patent Medicine
3. Traditional Chinese medicines prepared in ready-to-use forms
4. Pre-marketing drug
5. Purposes
6. Analytic perspective
7. Research period
8. Subject investigated
9. Description of disease investigated
10. Research units and staff
11. Management and supervision
12. Research design
13. Theoretical hypothesis
14. Choosing of sample population and control group
15. Cost
16. Effectiveness
17. Data analytic method
18. Evaluation
19. Post-marketing drug
20. Purposes and analytic perspective
21. Choosing of drug
22. Choosing of drug efficacy
23. Description of drug, disease and its economic burden
24. Current clinical norms
25. Common curative methods and application
26. Research unit and staff, process management and supervision, and relationship
announcement
27. Research design
28. Cost
29. Effectiveness
30. Reevaluation of validity of Chinese Traditional Patent Medicine
31. Monitoring adverse reaction
32. Discounting of cost and benefit
33. Uncertainty
34. Data analysis
35. Evaluation methods
36. Ethic analysis
37. Outcome report

Part Five. Appendix

Appendix One------ Glossary
1. Analytic perspective
2. Evaluation design
3. Subgroup analysis
4. Evaluation methods
5. Classification and measurement of costs
6. Classification and measurement of outcomes
7. Discounting and discounting rate
8. Modeling analysis
9. Uncertainty
10. Sensitivity analysis
11. Generalization

Appendix Two------ Report Format
1. Background
2. Methods
3. Outcomes
4. Discussion
5. Results
6. Relationship
7. References
8. Appendix

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