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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