Monitoring Multiple U.S. Government-Supported Covid-19 Vaccine Trials.

Monitoring U.S. Government-Supported Covid-19 Vaccine TrialsOperation Warp Speed was a partnership created to accelerate the development of Covid-19 vaccines. The National Institutes of Health oversaw one data and safety monitoring board to review/monitor all Operation Warp Speed trials. This article describes the challenges faced in monitoring these trials and provides ideas for future similar endeavors.

Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials.

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.

Medicine. The need for a global HIV vaccine enterprise.

A new collaborative model of research is needed to increase resources, to prioritize the R (ii) to increase the pace, reduce the overlap, and more systematically explore the elements of and delivery systems for vaccines; (iii) to use common standards for the prompt comparative testing of vaccine candidates; (iv) to expand resources for manufacturing vaccine candidates to speed their use in human trials; and (v) to increase the capacity for international clinical trials and to focus this effort toward quickly measuring the effectiveness of vaccine protection as prototype vaccine candidates are identified.

Politics, the media and science in HIV/AIDS: the peril of pseudoscience.

The microchip, the computer and the DNA revolution have brought the questions of ethics, counselling and equitable research to the fore. The new world order is a world of: equity; human rights; human dignity; the alleviation of poverty; closing the gap between the "haves and have nots". The social and economic impact and implications of these have opened a new dialogue between the professions and the laypersons in order to address matters of rights, ethics and power relationships in health research that is unprecedented in history. The yearning need for science to be understood by the public; the need for scientists to communicate better; the need for the public to make choices about what science has to offer in their daily life; the need for the public to participate and shape the scientific process; the need for science to integrate the wealth of information that is already existent has never been greater than today. Perhaps no examples illustrate these challenges better than the revolution in biology (the Human Genome Project and embryo stem cell research/therapy) and the human immunodeficiency virus (HIV)/AIDS epidemic that is sweeping sub-Saharan Africa (1). The way we teach, learn and practice science will no longer be the same. It will no longer be business as usual. It is unfortunately also within this context that pseudoscience is likely flourish (2).