Computerized Systems Used In Clinical Trials
The World Health Organisation (WHO) has raised safety concerns about the fast-tracking of a vaccine for the H1N1 flu virus. The European Medicines Agency (EMA) has accelerated this approval process for this vaccine, which is likely to see it becoming available in Europe 2 months before the US (1). Essentially, this means that large-scale clinical trials in humans will be bypassed.
But clinical trials are necessary to ensure the safety, as well as the efficacy, of all drugs and vaccines that are used in humans. So, is the WHO right in being cautious?
Stages of Clinical Trials
Clinical trials are necessary to ensure that all drugs that are available for human use are safe and effective. This involves rigorous testing in large numbers of people, both healthy people and those with the disease the drug is designed to treat (2).
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