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J Infect Dis ; 224(12): 1995-2000, 2021 12 15.
Article in English | MEDLINE | ID: covidwho-1233857


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.

COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , COVID-19/prevention & control , Aged , COVID-19 Vaccines/administration & dosage , Humans , SARS-CoV-2 , United States , Vaccines
Stat Med ; 40(11): 2536-2539, 2021 05 20.
Article in English | MEDLINE | ID: covidwho-1226206
Stat Med ; 40(11): 2499-2510, 2021 05 20.
Article in English | MEDLINE | ID: covidwho-1219208


The world has experienced three global pandemics over the last half-century: HIV/AIDS, H1N1, and COVID-19. HIV/AIDS and COVID-19 are still with us and have wrought extensive havoc worldwide. There are many differences between these two infections and their global impacts, but one thing they have in common is the mobilization of scientific resources to both understand the infection and develop ways to combat it. As was the case with HIV, statisticians have been in the forefront of scientists working to understand transmission dynamics and the natural history of infection, determine prognostic factors for severe disease, and develop optimal study designs to assess therapeutics and vaccines.

Acquired Immunodeficiency Syndrome , COVID-19 , Influenza A Virus, H1N1 Subtype , Acquired Immunodeficiency Syndrome/drug therapy , Acquired Immunodeficiency Syndrome/epidemiology , Humans , Pandemics , SARS-CoV-2
Clin Trials ; 17(5): 467-471, 2020 10.
Article in English | MEDLINE | ID: covidwho-638611


The first rumblings about a new coronavirus spreading in China were heard in January 2020. By the end of that month, the World Health Organization, recognizing the severity of the disease and the potential for global spread, had declared a public health emergency. By February 2020, cases had been identified in multiple countries, clinical trials of treatments with some biological plausibility had begun in China, and the initial steps of vaccine development were underway. In mid-March, by which time countries around the world were experiencing rapidly increasing numbers of cases and deaths, the World Health Organization categorized the outbreak as a pandemic. This new coronavirus was designated SARS-COV-2 in recognition of its similarity to the coronavirus responsible for the severe acute respiratory syndrome outbreak in 2002-2003. The race is on to develop treatments that can mitigate the severe consequences of infection and vaccines that can prevent infection and/or diminish the severity of disease in those who do get infected. Many challenges face these development efforts. Some are similar to those faced in the past; others are new. The urgency of finding ways to treat, and ultimately prevent, the consequences of this new and potentially deadly infection has led to unprecedented focus on clinical trials.

Betacoronavirus , Clinical Trials as Topic/methods , Coronavirus Infections/epidemiology , Disease Transmission, Infectious/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/epidemiology , COVID-19 , Humans , SARS-CoV-2