Post-Northwick Park European guidelines out for consultation
pharmafile | March 26, 2007 | News story | Research and Development |Â Â phase IÂ
European regulators have produced draft guidance for phase I research, designed to minimise the risk of a repeat of the disastrous Northwick Park trial.
The guideline focuses on first-in-man clinical trials for high-risk new medicines where the way they work or the limited relevance of pre-clinical research raises concerns that they could cause serious adverse reactions.
It comes in the wake of last year's phase I trial at Northwick Park Hospital during which six men fell critically ill during testing of TGN-1412, a new medicine for diseases such as rheumatoid arthritis and B-cell chronic lymphocytic leukaemia.
The trial was carried out by contract research organisation Parexel for the drug's manufacturers, the German biotech company TeGenero, which has since filed for insolvency.
The trial has already prompted the MHRA to make wide-ranging changes to the way research is conducted in the UK, but the EMEA's new guideline sets out a common approach to European first-in-man clinical trials.
It gives guidance on managing the transition from non-clinical studies – animal or in vitro tests – to the clinic and looks at quality, non-clinical and clinical aspects, including calculating first doses for humans.
Comments from a number of stakeholders, including the pharmaceutical industry, will be taken into account at the end of the two-month consultation period before the guideline is finalised.
The draft guideline is open for comment until 23 May 2007 and can be found here
Related news:
Closer scrutiny for high-risk clinical trials
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