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Preclinical challenge studies of AIDS vaccines in non-human primates have an important role in the AIDS vaccine development effort. However, to be most useful, challenge models need to be improved to more closely reflect the actual biological circumstances of HIV-1 infection and transmission in humans.
A few, high profile disasters in clinical trials in recent years have thrust the area of human subject research into the regulatory spotlight. The US has been quickest to react to public concern by introducing systems to tighten-up oversight mechanisms. The UK is now examining its clinical policies and here the authors question the best way forrward.
