Experience of patient trials and knowledge of the biological compounds emerging from development were among the factors that have won LCG Bioscience the new MHRA supplementary accreditation for UK Phase 1 Units.

The need for specialist centres, such as LCG Bioscience, with the necessary expertise and facilities to conduct complex studies was highlighted in a report by the Expert Scientific Group (ESG) that was set up to investigate the events surrounding the ill-fated TGN-1412 study.

The new accreditation scheme came into operation in April 2008 and provides formal guidance on the standards expected in a unit conducting First In Human (FIH) Trials. The two tiers of assessment are 'Standard' and 'Supplementary'. Standard accreditation indicates that a company has been assessed as being competent to perform most phase I clinical trials. Supplementary accreditation is reserved for centres who can demonstrate experience and have robust systems in place for the conduct of FIH trials involving drugs that would require EAG (Expert Advisory Group) review.

Anthony Priestley, Medical Director at LCG Bioscience, a centre of excellence for exploratory and early phase clinical development, believes that the new Supplementary accreditation is an important initiative by the MHRA:

"The UK has always been a preferred location for early phase clinical trials. The scheme demonstrates the advanced state of research governance in this country and provides reassurances to study participants that their safety is paramount."

The Supplementary accreditation permits a centre to perform trials with drugs that require a review of risk factors by EAG. The number of drugs in development that meet this definition is increasing, and there exists a clear need for specialist centres that have the necessary expertise to conduct the studies. The UK's Accreditation scheme has been introduced at an opportune moment, with the pharmaceutical industry facing new challenges as a consequence of the increasing complexity of the molecules now in development.

Whilst a demonstration of safety remains the foremost objective of the first studies in man there is a need to prove as early as possible that the drug is reaching its target and having the desired effect.