Problems inherent in all the research strategies (case reports, passivesurveillance, LLDBs, and clinical trials) include the implicationsof not using unvaccinated children or adults as controls, a lackof information on the background incidence rates of the adverse reactions,long latencies for some reactions, and reactions with multifactorialetiologies. Basic research on both vaccines and the pathophysiologiesof adverse reactions should be continued.

SUMMARY

In sum, there was agreement that more consideration needs to be givento the use and utility of case reports, including those submittedto passive surveillance systems, that the role of clinical trials(including postmarketing studies) is limited due to frequent lackof randomization and small sample size, and that LLDBs show greatbut not unlimited promise. Vaccine safety must be studied on an ongoingbasis and with a variety of tools, including basic research.

REFERENCES

Asbury AK, Cornblath DR. Assessment of current diagnostic criteria for Guillain-Barré syndrome. Annals of Neurology 1990; 27(Suppl.):S21–S24.

Asbury AK, Arnason BG, Karp HR, McFarlin DE. Criteria for diagnosis of Guillain-Barré syndrome. Annals of Neurology 1978;3:565–566.

Institute of Medicine. Howson CP, Howe CJ, Fineberg HV, eds. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC: National Academy Press; 1991.

Institute of Medicine. Stratton KR, Howe CJ, Johnston RB, eds. Adverse Events Associated with Childhood Vaccines: Evidence Bearingon Causality. Washington, DC: National Academy Press; 1994a.

Institute of Medicine. Stratton KR, Howe CJ, Johnston RB, eds. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. Washington, DC: National Academy Press; 1994b.

Kramer MS. Difficulties in assessing the adverse effects of drugs. British Journal of Clinical Pharmacology 1981;11:105S–110S.

Kramer MS, Lane DA. Causal propositions in clinical research and practice. Journal of Clinical Epidemiology 1992;45:639–649.



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Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary Problems inherent in all the research strategies (case reports, passivesurveillance, LLDBs, and clinical trials) include the implicationsof not using unvaccinated children or adults as controls, a lackof information on the background incidence rates of the adverse reactions,long latencies for some reactions, and reactions with multifactorialetiologies. Basic research on both vaccines and the pathophysiologiesof adverse reactions should be continued. SUMMARY In sum, there was agreement that more consideration needs to be givento the use and utility of case reports, including those submittedto passive surveillance systems, that the role of clinical trials(including postmarketing studies) is limited due to frequent lackof randomization and small sample size, and that LLDBs show greatbut not unlimited promise. Vaccine safety must be studied on an ongoingbasis and with a variety of tools, including basic research. REFERENCES Asbury AK, Cornblath DR. Assessment of current diagnostic criteria for Guillain-Barré syndrome. Annals of Neurology 1990; 27(Suppl.):S21–S24. Asbury AK, Arnason BG, Karp HR, McFarlin DE. Criteria for diagnosis of Guillain-Barré syndrome. Annals of Neurology 1978;3:565–566. Institute of Medicine. Howson CP, Howe CJ, Fineberg HV, eds. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC: National Academy Press; 1991. Institute of Medicine. Stratton KR, Howe CJ, Johnston RB, eds. Adverse Events Associated with Childhood Vaccines: Evidence Bearingon Causality. Washington, DC: National Academy Press; 1994a. Institute of Medicine. Stratton KR, Howe CJ, Johnston RB, eds. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. Washington, DC: National Academy Press; 1994b. Kramer MS. Difficulties in assessing the adverse effects of drugs. British Journal of Clinical Pharmacology 1981;11:105S–110S. Kramer MS, Lane DA. Causal propositions in clinical research and practice. Journal of Clinical Epidemiology 1992;45:639–649.