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

A new look at demographic transformation for universities in South Africa

We used our previously defined ‘Equity Index’ to determine the demographic profile of the 23 universities in South Africa’s higher education sector. We undertook an analysis of the demographic profiles of both students and staff based on audited 2011 data from the Higher Education Management Information System. We also considered an equity-weighted research index. We show the general applicability of the Euclidean formula in calculating 230 equity indices within the university sector. All institutions in the country were ranked in these categories. These rankings are quite instructive as to the demographics of the sector, both nationally and for individual institutions. No university has reached the ideal Overall Equity Index of zero and none falls within a 5% tolerance of the national demographic data. Four groups of universities emerge: those with good equity indices and low research productivity; those with poor equity indices and low research productivity; those with poor equity indices and high research productivity; and, finally, those with good equity indices and high research productivity. This index is the first quantitative measure that can be incorporated into an analysis of transformation. The Equity Index adds an innovative ‘new look’ to the profile and differentiation of the South African higher education landscape, and should become an important policy tool in steering the system towards a notion of transformation that connects, rather than disconnects, equity, development and differentiation. The index may also become a useful universal measurement of equity in higher education (and other) systems globally

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