Expert guidance on clinical trial safety

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Recommendations and new test in light of Phase I disaster

Clinical trial design in the UK is due for a shake up following the recommendations of an expert group commissioned in light of a disastrous trial that left six subjects fighting for their lives

In March this year, six young men suffered extreme, and almost instantaneous, adverse reactions to an intravenous dose of TGN1412, a monoclonal antibody selected to stimulate the body’s immune response. The drug caused a massively amplified immune response. An independent expert group was commissioned by the health secretary Patricia Hewett to examine trials of new drugs.

The list of 22 recommendations now made by the group echoes those made by other experts (Chemistry World, September 2006, p14). Notably, that drugs which have never been administered to people before should first be tested at extremely low doses, and that such drugs should be administered to only one subject at a time.

With this notable exception, clinical trials in the UK have a good safety record, but some of the recommendations might surprise non-experts.

’A broader approach to dose calculation, beyond reliance on "no observable effect level" or "no observable adverse effect level" in animal studies, should be taken,’ the group suggested.

At the release of the report, group member Stephen Inglis, director of the National Institute for Biological Standards and Control, London, UK, hinted at a new test developed at NIBSC which could predict similar reactions in future. The test, as yet unpublished, records the response of human immune cells to immobilised antibodies.

’With present advances in biology, biological chemistry, informatics and biotechnology, we can expect the identification of many new therapeutic targets and the development of innovative medicines to fill unmet clinical needs,’ noted the report’s authors. ’It is important that the regulation of medicines is science-based and that the regulatory process keeps pace with, and is appropriate for, the science and technology that will give rise to tomorrow’s medicines,’ concluded the report’s authors.

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