LCG welcomes final plans for UK Ph I test units

Final plans from the UK's Medicines and Healthcare products Regulatory Authority (MHRA) for accreditation of Phase I testing units aimed at restoring confidence in clinical trials, have been greeted positively by LCG Bioscience. The new accreditation scheme comes into operation in April, and LCG Bioscience says it has fully adopted the requirements in preparation.

"It is important to ensure public confidence and the accreditation scheme provides this reassurance by bringing together a number of strands of best practice within a well structured framework," said Dympna Starling, head of quality assurance at UK-based LCG.

A March 15, 2006, trial of hybird monoclonal antibody drug TGN1412 in London's Northwick Park Hospital, left six men severely injured and prompted a report by a UK expert scientific group, chaired by Gordon Duff (Marketletters passim). The MHRA Accreditation Scheme provides formal guidance on the standards expected in a unit conducting first-in-human trials involving the administration of molecules where the risk may be difficult to predict, Ms Starling stated. "The Duff Report recommendations address the way the initial FIH dose is determined and administered, the safety and emergency procedures in the clinical unit and also encourages greater openness between researchers and doctors," she noted.