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Research Strategies for Assessing Adverse Events Associated with Vaccines A Workshop Summary (1994) / Chapter Skim
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CLINICAL TRIALS
Pages 14-15

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From page 14...
... Discussion Participants expressed the opinion that, with all the limitations and problems of passive surveillance and LLDBs, as discussed earlier, the premarketing period is the best time to obtain data on the safety of vaccines. However, premarketing studies conducted to support licensure often use sample sizes more appropriate for studying efficacy and commonly occurring adverse events and usually do not study samples large enough to detect rarely occurring adverse events.
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From page 15...
... They responded that in general, prevention trials usually require much larger sample sizes and longer time periods for their completion than treatment trials and that the cost is correspondingly greater. In addition, it is difficult to get sufficient people to accept randomization in vaccine trials for a period sufficient to detect rare adverse events (this is discussed in a subsequent section)
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Key Terms

  • phase iii
  • rare adverse
  • clinical trials
  • occurring adverse
  • iii trials

  • larger sample
  • vaccine trials
  • study protocols
  • help interpret
  • participant commented

  • blinded studies
  • iii study
  • detect rarely
  • passive surveillance
  • information comes

  • fda ensures
  • million doses
  • prefers randomized
  • trials include
  • aseptic meningitis

  • studying efficacy
  • obtain data
  • standardized forms
  • usually require
  • accept randomization

  • participant cited
  • therapeutic products
  • studies whenever
  • trials usually
  • detect rare


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