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R&D news in brief

Our weekly round-up of the R&D news in brief

PowderMed files for H5N1 trial
British firm, PowderMed is hoping to run the first human clinical tests of a needle-free vaccine against the H5N1 (avian flu) virus, after filing for regulatory permission in the UK.

The new vaccine, based on PowderMed's proprietary technology, fires gold particles coated with DNA (encoding genes specific to the flu strain) at supersonic speed into the immune cells of the skin.

A previous PowderMed study in the US found that the technology was able to produce 100 per cent protective immune responses in adult volunteers against normal seasonal flu.

FDA to explore adaptive clinical trials
The US Food and Drug Administration (FDA) has announced plans to develop regulatory guidelines for o-called `adaptive' clinical trials - tests which change course as they go along.

The results of an adaptive trial are observed closely, and modifications are made to the design as it progresses, usually based on findings such as the efficacy of treatments or which group of patients appears to be benefiting most from a particular trial.

ìWe think it's time to start exploring the appropriate use of these designs in the appropriate situations,î said Robert O'Neill, director of the FDA's office of biostatistics.

30th September 2008

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