Considerations for unblinding individual study participants during vaccine trials

被引：0
|
作者：
Halsey, Neal [1 ]
Evans, Stephen [2 ]
Santosham, Mathuram [1 ]
Hacker, Adam [3 ]
Edwards, Kathryn M. [4 ]
Chandler, Rebecca E. [3 ]
Dudley, Matthew Z. [1 ]
Dekker, Cornelia L. [5 ]
Al-Abri, Seif
Arora, Narendra [6 ]
Buttery, Jim [7 ]
Dodoo, Alex [8 ]
Eskola, Juhani [9 ]
Heininger, Ulrich [10 ]
Jee, Youngmee [11 ]
Khuri, Najwa [12 ]
Obaro, Stephen [13 ]
Orenstein, Walt [14 ]
Pitisuttithum, Punnee [15 ]
Safadi, Marco [16 ]
Whitney, Cynthia G. [14 ]
Black, Steve [17 ]
机构：
[1] Johns Hopkins Bloomberg Sch Publ Hlth, Dept Int Hlth, Baltimore, MD 21205 USA
[2] London Sch Hyg & Trop Med, London, England
[3] Coalit Epidem Preparedness Innovat, Oslo, Norway
[4] Vanderbilt Univ, Nashville, TN USA
[5] Stanford Univ, Sch Med, Stanford, CA USA
[6] INCLEN Trust Int, New Delhi, India
[7] Univ Melbourne, Melbourne, Vic, Australia
[8] Univ Ghana, Accra, Ghana
[9] Natl Inst Hlth & Wellfare, Helsinki, Finland
[10] Univ Basel, Childrens Hosp, Basel, Switzerland
[11] Inst Pasteur Korea, Seongnam, South Korea
[12] Univ Jordan, Amman, Jordan
[13] Univ Nebraska Med Ctr, Omaha, NE USA
[14] Emory Univ, Atlanta, GA USA
[15] Mahidol Univ, Bangkok, Thailand
[16] Sao Paulo Sch Med Sci, Sao Paulo, Brazil
[17] Global Vaccine Data Network, Auckland, New Zealand
来源：
VACCINE | 2023年 / 41卷 / 22期
关键词：
Vaccine; Vaccine trials; Regulatory guidance; Vaccine safety; Unblinding; Adverse events; THROMBOTIC THROMBOCYTOPENIA; DIAGNOSIS; SAFETY; UPDATE;
D O I：
10.1016/j.vaccine.2023.04.033
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
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 man-agement of adverse events following immunization. (c) 2023 The Author(s). Published by Elsevier Ltd.
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页码：3399 / 3402
页数：4
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