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10.1093/infdis/jiab263 http://scihub22266oqcxt.onion/10.1093/infdis/jiab263 34008027!8240876!34008027     free     free     free Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       J+Infect+Dis 2021 ; 224 (12): 1995-2000 Nephropedia Template TP {{tp|p=34008027|t=2021. Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials |pdf=|usr=}}{{34008027}} gab.com Text Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials JO: J Infect Dis http://www.kidney.de/pget.php?&tw=1&pmid=34008027 #FOAvip To speed the development of vaccines against SARS-CoV-2, the United States Federal Government has funded multiple phase 3 trials of candidate vaccines. A single 11-member data and safety monitoring board (DSMB) monitors all government-funded trials to ensure coordinated oversight, promote harmonized designs, and allow shared insights related to safety across trials. DSMB reviews encompass 3 domains: (1) the conduct of trials, including overall and subgroup accrual and data quality and completeness; (2) safety, including individual events of concern and comparisons by randomized group; and (3) interim analyses of efficacy when event-driven milestones are met. Challenges have included the scale and pace of the trials, the frequency of safety events related to the combined enrollment of over 100 000 participants, many of whom are older adults or have comorbid conditions that place them at independent risk of serious health events, and the politicized environment in which the trials have taken place. Twit Text FOAVip Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials ????J Infect Dis http://www.kidney.de/pget.php?&tw=1&pmid=34008027 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=34008027 #FOAvip English Wikipedia <ref>{{Cite pmid|34008027}}</ref> Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials #MMPMID34008027 Joffe S; Babiker A; Ellenberg SS; Fix A; Griffin MR; Hunsberger S; Kalil J; Levine MM; Makgoba MW; Moore RH; Tsiatis AA; Whitley R J Infect Dis 2021[Dec]; 224 (12): 1995-2000 PMID34008027show ga To speed the development of vaccines against SARS-CoV-2, the United States Federal Government has funded multiple phase 3 trials of candidate vaccines. A single 11-member data and safety monitoring board (DSMB) monitors all government-funded trials to ensure coordinated oversight, promote harmonized designs, and allow shared insights related to safety across trials. DSMB reviews encompass 3 domains: (1) the conduct of trials, including overall and subgroup accrual and data quality and completeness; (2) safety, including individual events of concern and comparisons by randomized group; and (3) interim analyses of efficacy when event-driven milestones are met. Challenges have included the scale and pace of the trials, the frequency of safety events related to the combined enrollment of over 100 000 participants, many of whom are older adults or have comorbid conditions that place them at independent risk of serious health events, and the politicized environment in which the trials have taken place. |Aged[MESH] |COVID-19 Vaccines/administration & dosage/*adverse effects/*immunology[MESH] |COVID-19/*prevention & control[MESH] |Humans[MESH] |SARS-CoV-2[MESH] |United States[MESH]Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials (epmc).pdf DeepDyve Pubget Overpricing