GALA Trial Co-ordinator Trial Management GALA behind the scenes Bridget Colam GALA Trial Co-ordinator Funding: Health Foundation, ESVS

GALA Pilot Phase – 678 patients 500 1000 1500 2000 2500 3000 3500 Target: 20 UK centres – 400 patients by the end of 2002 Number of patients 1999 2000 2001 2002 2003 2004 2005 2006 2007 Total randomised by year Funding: Health Foundation, ESVS

Summary: GALA Pilot Phase Ethics Committee restricted GALA to 20 UK centres 400 patient target reached before the end of 2001 After the target was reached: dilemma – how to go forwards when funding only left for one more year? Immediately increase centres with no future £ promised? Continue randomising and wait for Main Phase funding? Message: Don’t loose momentum Funding: Health Foundation, ESVS

Wait for Main Phase funding Continue Randomising Wait for Main Phase funding 500 1000 1500 2000 2500 3000 3500 Funding news Number of patients 1999 2000 2001 2002 2003 2004 2005 2006 2007 Pilot Phase Total randomised by year Funding: Health Foundation, ESVS

GALA total : 3,526 patients Number of patients 500 1000 1500 2000 2500 3000 3500 Number of patients 1999 2000 2001 2002 2003 2004 2005 2006 2007 Pilot Phase Main Phase Total randomised by year Funding: Health Foundation, ESVS

UK and Non UK Centres Number of patients randomised/year Non UK UK 900 800 Non UK UK 700 600 500 Patients 400 300 200 100 1999 2000 2001 2002 2003 2004 2005 2006 2007 Funding: Health Foundation, ESVS

Carotid Surgery Trials Number Randomised in Carotid Surgery Trials 4000 3526 3500 3120 3024 3000 2267 2500 2000 Number of Patients 1500 1000 500 NASCET ECST ACST 1 GALA North American Symptomatic Carotid Endarterectomy Trial European Carotid Surgery Trial Asymptomatic Carotid Surgery Trial General Anaesthetic v Local Anaesthetic for Carotid Endarterectomy Funding: Health Foundation, ESVS

GALA Main Phase Challenges to recruitment and good data collection: Changing trial bureaucracy in UK and Non UK: increased data protection – getting major event details (2004) EU Directive – was GALA now a drug trial? different ethics system requirements between countries – some tighter than others Translation, local cultural differences and systems The ACST results increased the number of asymptomatic patients randomised into GALA GALA recruited patients for 7.5 years – surgery changed Funding: Health Foundation, ESVS

Things that helped GALA Money and support for getting the centres on board: The Health Foundation (UK then Non UK) European Society for Vascular Surgery (Non UK) GALA stands at National Conferences Recruitment: Web randomisation system Data: Trial office team that wouldn’t give up on missing data! Support from collaborators: Helping to get centres through local ethics Translation, chasing data across boarders! Funding: Health Foundation, ESVS

GALA Trial 1999 - 2008 Message: To be successful, large trials being set up now need to be well funded, simply designed and have a good supportive international collaboration like the GALA trial Extra help would be: Short trial duration so less time for things to change! Randomise a higher proportion of eligible patients Funding: Health Foundation, ESVS