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4 The Vaccine Safety Datalink Research Process and the Release of Preliminary Findings
Pages 76-95

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From page 76...
... They found weak associations of asthma with Haemophilus influenzae type b vaccine and Hepatitis B vaccine, which the authors attributed partially to a bias in health care utilization or information bias (for example, they could not verify that a child who according to the medical record was unvaccinated was not accessing health care elsewhere) (DeStefano et al., 2002)
From page 77...
... decided that this topic should be addressed by using VSD data, so NIPaffiliated VSD researchers conducted a pilot study in 1998 (DeStefano, 2004)
From page 78...
... and American Academy of Pediatrics statement recommended reduction or elimination of thimerosal in vaccines as a precautionary measure (CDC, 1999b)
From page 79...
... . In April 2000, the lead study author presented preliminary findings at the annual Epidemic Intelligence Service conference.
From page 80...
... . VACCINE SAFETY DATALINK RESEARCH PLAN The VSD is the only population-based resource in the nation that has sufficient sample size to address possible concerns about rare adverse effects of vaccines.
From page 81...
... Recommendation 4.1: To enhance the value of the VSD, to improve the credibility of results derived from it, and to support CDC's role in assessing vaccine safety, the committee recommends that the NIP develop an annual VSD research plan. The plan should define the priorities for new studies and support of current studies.
From page 82...
... The committee finds it reasonable for the public to expect that some portion of the contract funding will be made available to support meritorious research proposals by researchers not affiliated with the NIP or the VSD MCOs. Recommendation 4.2: To support greater use of the VSD and to pro mote opportunities for collaborative work outside the existing com munity of VSD researchers, the committee recommends that the annual VSD research plan include provisions for allocating some existing funds, on a competitive basis, to external researchers inter ested in conducting collaborative work with VSD data.
From page 83...
... Detailed documentation of research protocols, analysis decisions, and deviations from protocols is important for ensuring the integrity of the scientific process and specifically for ensuring public confidence in the integrity of VSD studies conducted by NIP-affiliated and MCO-affiliated VSD researchers. Thorough documentation and archiving of all study methods and analysis decisions can be considered the equivalent of keeping good laboratory notebooks.
From page 84...
... Providing information about studies that are in progress is an important way to promote credibility, trust, and transparency between the NIP and members of the public who are concerned about vaccine safety. Such a research clearinghouse would also constitute a mechanism for promoting collaboration in that external researchers who are interested in conducting studies with VSD data could more easily identify experienced VSD researchers with whom they might collaborate.
From page 85...
... could promote transparency and help to foster public trust. If the public is confident that there is a transparent, standardized process for documenting the status of proposals and that information about use of the VSD data sharing program is made known on a regular schedule, there may be less concern and suspicion about the processes that the NIP and NCHS use to implement the data sharing program.
From page 86...
... The choice depends on whether the public health concern is considered routine or nonroutine. For routine public health concerns, the process that the NIP uses consists of (Bernier, 2004b)
From page 87...
... Because data are incorporated into the VSD database annually, concerns about preliminary findings affecting continual data accrual are not applicable here. The question of the release of preliminary findings based on VSD data has an additional layer of complexity related to the multistage process that is used to test a hypothesis.
From page 88...
... Preliminary Data Compared with Preliminary Findings The difference between preliminary data and preliminary findings must also be understood. At the committee's October 2004 meeting, representatives of the NIP described how the NIP conceptualizes preliminary data compared with preliminary findings.
From page 89...
... In the case of the VSD, however, the committee finds that because the data are incorporated into the VSD data files annually rather than continually, there will rarely be situations in which preliminary findings are so urgent that they cannot undergo independent external peer review. Preliminary findings from true surveillance systems may yield quickly emerging findings, but this will rarely be the case with findings from the VSD.
From page 90...
... Peer review of findings that are the basis of a vaccine safety-related policy decision should always be linked to the policy role of the NIP. The committee believes that there should be external peer review of any preliminary findings that the NIP uses as the basis of or to support a policy decision, although the external review need not be done in the traditional way.
From page 91...
... Ultimately, routine and widespread dissemination of preliminary results can sometimes undermine public trust if preliminary conclusions fail verification and are changed (Weijer, 2004)
From page 92...
... When to Release Preliminary Findings Despite those concerns, in various situations it is appropriate to release preliminary findings about potential vaccine-related risks based on VSD data. In the case of the thimerosal screening analysis (Verstraeten et al., 2003a)
From page 93...
... That all members of the general public should have equal access to information from the federal government is a vital component of the Federal Advisory Committee Act, the Government in the Sunshine Act, and the Freedom of Information Act. Recommendation 4.7: The committee recommends that preliminary findings from VSD data be shared with the public whenever the findings are presented to anyone other than collaborators in the re search, federal employees responsible for research activities, MCO affiliated VSD researchers, scientific journals, peer reviewers for scientific journals, and people responsible for oversight of the re search.
From page 94...
... However, there may be reasons to review earlier stages in the research process; for example, to determine whether and how something may have gone wrong, to allocate proper credit for scientific advances, or to simply understand scientific processes. Because the peer-review process is designed to ensure the validity and scientific quality of the final results, preliminary findings should not be relied on as the most valid interpretations of the data.
From page 95...
... Recommendation 4.10: The committee recommends that any pre liminary findings based on VSD data that are shared with the pub lic be put into appropriate statistical and scientific context with clear characterization of the uncertainties in the findings, of the strengths and limitations of the data, and of the possibility that new data or new analyses could change interpretations.


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