INIS in UK Europe

1
INIS in UK / Europe

• Dr Dan Hawcutt
• Clinical Research Fellow
• National Perinatal Epidemiology Unit
• Oxford
• UK

2
Introduction

• Hello from Oxford
• UK centres
• Current / Future
• How to recruit centres in UK
• Europe
• Progress
• European Directive on Clinical trials
• Follow up questionnaires

3
INIS Team In Oxford
4
UK Centres

• 54 UK centres
• Smaller than Australian centres
• From Dundee to Truro
• Largest trial in NPEU currently
• Visits and support
• Myself
• 2 Part time INIS nurses
• Jeanette Debbie (New)

5
Recruiting a UK centre

• Find interested consultant
• Find neonatal nurse
• Get local ethical approval
• National approval (MREC) already given!
• Guaranteed to raise something
• Get hospital RD approval
• Get hospital pharmacy to agree (easy)

6
Recruiting a UK centre

• Mailing Campaign
• Using Directory of NNU in UK
• More than 200 admissions per year
• Advertising
• Insert into British Association of Perinatal
  Medicine newsletter last month
• Conferences
• Attending Neonatal Nurses conference March

7
Recruiting a UK centre

• Entire process can take MONTHS

8
Recruiting a UK centre

• Continual recruitment process
• Most Recent Additions
• Hillingdon (London)
• St Michaels (Bristol)
• About 20 more centres in the process

9
INIS in Scotland

• 5 centres already recruiting
• Remaining centres in the process
• Some of the best recruiters in the UK
• New local co-ordinator in situ
• Dr M. Ibrahim

10
INIS in Europe

• Continual efforts to get mainland Europe
• Previous problems with translations
• Relied on busy clinicians
• Slow but accurate
• Now have private translation service
• Fast
• Accurate
• More Expensive

11
Process of getting into Europe

• Identify interested clinicians
• Ethical Approval
• Requires translations
• Permission to use import the drug
• Procedure varies widely in various countries
• Italy permission from Ministry of Health
• Belgium permission of Hospital Pharmacist
• Remaining translations (if required)

12
Belgium (Flemish hospitals)

• All approval granted
• All translations completed
• Leuven Hospital ready
• Hope to expand to another 5 units
• Start up meeting on 20th March
• Helen McElroy to present
• Will be 1st European Centre

13
Serbia

• Most administrative hurdles jumped
• Translations completed
• Requires
• Import licence - pending
• Start up visit
• Insisting on having a professor visit and give
  talk
• No professors in our unit
• Promotion may be rapid in this game!!

14
Serbia
15
Ireland

• Delays with Drug approval
• Questions from Irish Medicines Board
• E.g. what type of glass placebo stored in
• SNBTS to reassure them
• Obviously no translation issues
• Hopefully up and running soon

16
Italy

• Only needed one or two translations
• 1st Hospital to be in Parma
• Awaiting Ministry of Health Approval
• Hope to present to national conference to raise
  awareness
• Looking forward to this start up meeting!

17
France ( French Belgium)

• LFB are funding and organising the study
• They are sorting
• Translations
• IVIG and Placebo
• Will send all data to NPEU for inclusion
• Should provide many centres as no local approval
  needed
• Start up planned for June/July

18
European Directive

• EU wide law on clinical trials
• Published 2001
• Interpreted differently in countries
• UK interpretation quite strict
• Implementation on 1st May 2004

19
Aims of the directive

• Protect the rights, safety and wellbeing of trial
  participants
• Simplify and harmonize the administrative
  processes governing clinical trials conducted in
  the EU

20
Requirements

• Trial Registration
• Authorisation
• Good manufacturing practice (GMP)
• Good Clinical Practice (GCP)
• Regulatory agency set up to enforce
• Will charge trials to inspect them

21
Potential Benefits

• Parallel application to ethics and regulatory
  authority
• Revision of MREC/LREC system
• RD being rethought

22
Potential problems

• Sponsor
• Initiation, management /- finance
• Suits pharmaceutical trials
• Legal implications
• Failure to comply with regulations will be a
  criminal offence
• Extra expense

23
INIS implications

• INIS designed with directive in mind
• Already comply with
• MRC GCP
• MREC approval remains
• Drug authorisation automatically changes
• DDX becomes CTA (clinical trials authorisation)