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LCG Bioscience
LCG BIOSCIENCE EXPERIENCE WITH NOVEL COMPOUNDS GAINS THE CENTRE NEW MHRA SUPPLEMENTARY ACCREDITATION
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 assured."
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. This is giving rise to a new generation of hybrid protocols involving healthy volunteers, patients and biomarkers as Anthony Priestley explains:
"At LCG Bioscience we have specialist experience of large molecules and this includes the development of novel biomarkers for safety and physiological evaluations. Complex studies of this type require rigorous planning and meticulous study conduct. The accreditation provides sponsors with confidence that these procedures are in place."
Justin Watts, Director of Operations at LCG Bioscience believes that the new accreditation will drive up standards across the industry.
"Although the UK's accreditation scheme is a voluntary process I believe that over time it will become increasingly difficult for sponsors to justify the use of centres that do not participate. With this is mind, the early commitment to achieving supplementary accreditation is a key step in positioning our company as a centre of excellence in early phase clinical development." - ENDS -
For press enquiries about LCG Bioscience please
contact:
Rachel Holdsworth/Helen Goldrein, PR
consultants,
Holdsworth Associates, Tel 01954 202789,
rachel@holdsworth-associates.co.uk
About LCG Bioscience
LCG Bioscience is a specialist clinical research organisation for exploratory and early phase clinical development. Established in 1993, it performs Phase I and Phase IIa clinical studies and laboratory analysis for all phases. It has particular expertise in studies that require complex clinical procedures, special populations, or surrogate pharmacodynamic endpoints.
LCG Bioscience is an operating division of Bourn
Hall Ltd and is located at Bourn Hall, Bourn,
Cambridge, CB23 2TN, UK. Tel 01954 717217
