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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. GALA Trial
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