Considerations for unblinding individual study participants during vaccine trials
Premature unblinding of individual participants is rarely reported in publications, but such unblinding can disrupt vaccine trials by causing worry and drop-out of other participants or “pseudo unblinding,” in which participants or investigators over-interpret certain symptoms as being related to re...
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th-mahidol.823062023-05-19T14:58:03Z Considerations for unblinding individual study participants during vaccine trials Halsey N. Mahidol University Veterinary Premature unblinding of individual participants is rarely reported in publications, but such unblinding can disrupt vaccine trials by causing worry and drop-out of other participants or “pseudo unblinding,” in which participants or investigators over-interpret certain symptoms as being related to receiving an investigational product. This review summarizes appropriate reasons for unblinding in vaccine trials. Regulatory guidance could be improved by distinguishing guidance for vaccine trials from drug trials, with the recognition that unblinding individual participants in vaccine studies is rarely needed for management of adverse events following immunization. 2023-05-19T07:58:03Z 2023-05-19T07:58:03Z 2023-01-01 Article Vaccine (2023) 10.1016/j.vaccine.2023.04.033 18732518 0264410X 2-s2.0-85153933944 https://repository.li.mahidol.ac.th/handle/123456789/82306 SCOPUS |
| institution |
Mahidol University |
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Mahidol University Library |
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Asia |
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Thailand Thailand |
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Mahidol University Library |
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Veterinary |
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Veterinary Halsey N. Considerations for unblinding individual study participants during vaccine trials |
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Premature unblinding of individual participants is rarely reported in publications, but such unblinding can disrupt vaccine trials by causing worry and drop-out of other participants or “pseudo unblinding,” in which participants or investigators over-interpret certain symptoms as being related to receiving an investigational product. This review summarizes appropriate reasons for unblinding in vaccine trials. Regulatory guidance could be improved by distinguishing guidance for vaccine trials from drug trials, with the recognition that unblinding individual participants in vaccine studies is rarely needed for management of adverse events following immunization. |
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Mahidol University |
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Mahidol University Halsey N. |
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Article |
| author |
Halsey N. |
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Halsey N. |
| title |
Considerations for unblinding individual study participants during vaccine trials |
| title_short |
Considerations for unblinding individual study participants during vaccine trials |
| title_full |
Considerations for unblinding individual study participants during vaccine trials |
| title_fullStr |
Considerations for unblinding individual study participants during vaccine trials |
| title_full_unstemmed |
Considerations for unblinding individual study participants during vaccine trials |
| title_sort |
considerations for unblinding individual study participants during vaccine trials |
| publishDate |
2023 |
| url |
https://repository.li.mahidol.ac.th/handle/123456789/82306 |
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1781415417840926720 |