Vaccine Safety Research, Data Access, and Public Trust (2005) / Chapter Skim
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2 Description of the Vaccine Safety Datalink
2 Description of the Vaccine Safety Datalink
Pages 25-32
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When a biologics license application (BLA) is submitted for a specific vaccine, FDA, with advice from the Vaccines and Related Biological Products Advisory Committee (VRBPAC)
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.1 To supplement information contained in the CFR, FDA periodically makes available guidance documents that address various aspects of and issues related to vaccine safety.2 If the results of the Phase 1, 2, and 3 clinical trials support the safety, immunogenicity, and efficacy of the vaccine, the manufacturing facility is adequate, and the product of manufacture is consistent, the sponsor can submit a BLA to FDA. After consideration of the data, FDA, with advice from VRBPAC, can license the vaccine.
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The U.S. system of medical recordkeeping also does not allow direct links between vaccination and health outcomes, because medical record data are not maintained electronically in a standard format.
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For example, clinical detail is sparse, and care received outside the MCO is not noted. The VSD database links data on patient characteristics, health outcomes (according to data resulting from inpatient, outpatient, and emergency-room records)
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The contract supports the establishment and maintenance of an infrastructure across the MCOs participating in the VSD that allows scientifically rigorous and efficient monitoring of vaccine safety; creation and compilation of combined electronic files from each of the participating MCOs that link vaccination data, medical outcomes, and other relevant data; and evaluation of selected vaccine safety questions by analysis of the combined data provided by the participating MCOs (CDC, 2004d)
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The chart-reviewed data are not available to external researchers for new studies through the VSD data sharing program. These are datasets that arose specifically from retrospective studies, however, so many assumptions inherent in the study designs cannot be examined without repeating the data collection.
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The current VSD contract includes provisions to protect proprietary interests in relation to the VSD data sharing program (CDC, 2004e)
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. In that context, research data are defined as "the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues"; findings are considered published if they "are published in a peer-reviewed scientific or technical journal" or if a federal agency "publicly and officially cites the research findings in support of an agency action that has the force and effect of law" (OMB, 1999)
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