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OCR for page R5
Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary
Contents
INTRODUCTION AND BACKGROUND
1
CASE REPORTS AND PASSIVE SURVEILLANCE
2
Introduction
2
Discussion,
4
Suggested Improvements,
4
Data Analysis,
5
Signal Detection and Hypothesis Generation,
6
Use of Case Reports in Causality Assessment,
8
Education of Health Care Providers,
9
Vaccine Injury Compensation Program,
9
Evaluation of Passive Surveillance Systems,
9
LARGE-LINKED DATABASES
10
Introduction,
10
Discussion,
12
Strengths and Weaknesses of LLDBs,
12
Case Definitions,
13
Evaluation of LLDBs,
13
CLINICAL TRIALS
14
Introduction,
14
Discussion,
14
Randomization,
15
Standardization,
15
Participation in Clinical Trials,
16
Ethical Issues,
16
OTHER TOPICS
16
Unvaccinated Controls,
16
Background Incidence Rates,
17
Adverse Events with Long Latencies,
18
OCR for page R6
Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary
Multifactorial Etiologies,
19
Need for Basic Research,
19
SUMMARY
20
REFERENCES
20
ACRONYMS
21
WORKSHOP PARTICIPANTS
22