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Feature Infectious Disease

Trials at the ready: preparing for the next pandemic

BMJ 2012; 344 doi: (Published 03 May 2012) Cite this as: BMJ 2012;344:e2982

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  1. Ed Yong, Science writer
  1. 1London, UK

Researchers have previously struggled to carry out clinical trials on epidemics and the drugs used to treat them. Ed Yong finds out about the scientists who are changing that by planning ahead…

In 2009 the world squandered a prime opportunity to study a harmful virus. From March a strain of H1N1 influenza virus swept the globe, reaching six continents in three months. It infected between 11% and 21% of all the people on the planet, and gave us the perfect chance to learn more about a virus that has been troubling humanity for centuries. But we failed to make the most of it and, to date, still know surprisingly little about how to treat the pandemic strain.

The problem is that while viruses are fast and adaptable, clinical research is lumbering and cumbersome. Epidemics tend to arrive with little warning, spread quickly, and end abruptly. By contrast, clinical trials can take months to plan. Forms must be designed to record the right data and ethical approval must be sought. By the time would-be researchers can vault over these obstacles the epidemic is history.

This explains why, during the 2009 A/H1N1 influenza pandemic, virtually no patients were enrolled in a randomised controlled trial designed to identify the best ways of treating the infection. Such trials are the gold standard of medicine and the best way of getting rigorous evidence for a treatment’s effectiveness. During the pandemic millions of people were treated with the front line drug oseltamivir (Tamiflu). But the only evidence that oseltamivir actually saved lives came from retrospective observational studies, with all the biases they entail. To this date, serious questions remain about the drug’s effectiveness. “A Tamiflu trial during the last pandemic would have resolved all the controversy over whether it works or not,” says Mike Clarke, Director …

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