First-in-man clinical trial guidelines published by the EMEA
Strategies to identify and mitigate risks in first-in-man clinical trials have been set out by the European Medicines Agency (EMEA) (PDF 80K).
The final guideline on these strategies, published this week, applies
to trials of all new chemical and biological investigational products,
except those involving gene and cell therapy. It was developed in response
to the severe
adverse events suffered by volunteers in a first-in-man
trial in March 2006 (PJ, 18 March 2006, p307), with the aim of providing
a common approach across EU member states to first-in-man trials of high-risk
products.
The guideline says that study designs should be justified on a case-by-case
basis, that the novelty of the drug’s mode of action should be
considered and that the compatibility of the product with packaging and
administration systems should be investigated. Doses should be given
sequentially and the “minimal anticipated biological effect level” should
be used to determine initial doses for high-risk products.
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