Stoppages of clinical trials are a normal part of the testing process, and show that patient safety is being taken seriously.
The much-anticipated phase 3 trial of the University of Oxford’s coronavirus vaccine has been paused following aend the pandemicBut how worried should we be? Is the suspension of this trial a major setback in the research effort to find a solution? At this stage, it is difficult to say. What it does show is that the trial is fulfilling one of its main purposes – to rigorously test the safety of the vaccine in a large number of people., known as phases.
There are a number of possible ways to run a phase 3 trial, but generally a randomized controlled trial design is used. This randomly assigns participants to one of two groups: the active group, who get the vaccine being tested, or the control group, who get an inactive vaccine called a placebo. The aim is to show statistically that the active vaccine is more beneficial than the placebo.
All medical complications caused by any means – including accidents – are reported to the DSMC, which then considers whether the “adverse events” are connected to the vaccine. Sometimes this isn’t clear, and so the DSMC can request that the trial is stopped while an event is investigated. This is what seems to have happened with the Oxford vaccine trial.
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