Transcript Document

Working in partnership on Cancer R
and D
Professor Peter Barrett-Lee
Professor of Breast Cancer Studies
Cardiff University & Executive Lead
for R and D Velindre NHS Trust,
Cardiff
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Casual discussion
Attendance
meetings
Learned paper
Approach from
3rd party
Brainstorming
Out of the blue
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New drug - no
current therapy
New drug improve
outcomes
New drug - more
convenient
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Zoledronate IV 15
min Q3-4 weeks Gold
standard for MBC
Heavy use of day care
resources/patient
inconvenience
“ideal”
bisphosphonate is
oral
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“Equivalence” to Gold
standard in terms of
efficacy
New oral
bisphosphonate
tolerability
Type of trial needed
Patient numbers
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Form a small group
1.Close Clinical Colleagues
2.WCTU Involvement crucial at outset
3.Pharmaceutical company interest
4.Organisation support
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Design the trial!
1.Pragmatic
2.Relevant to NHS
3.Give it a name
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Randomised
Standard 3-4 weekly
Daily Oral Ibandronate
IV Zoledronate (4 mg)
(50 mg)
2 year duration
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Canvas support/opinion
1.Colleagues
2.Patients
3.Pharmaceutical company
4.CTAAC/CRUK
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Formal Questionnaire for support &
recruitment to all UK centres
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Trial organisation &
statistician-WCTU/SEWTU*
Pharmaceutical discussions
1. Medical
affairs/marketing
2. Global company
3. Money (£500K Roche)
4. Free drug supplies
Trial Sponsorship – Velindre
NHS Trust
NCRI/CRUK/CTAAC
Application (remember competing trials)
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Approval/funding
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Now the real work starts!
1. Formalise TMG & Finalise protocol complying
with EU directive & GCP
2. MREC submission with PIS/QoL
3. Case record forms & SOP
4. Set Up TSG/DMEC
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Trial organisation & sponsorship
Set up of all UK sites/Monitoring etc
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PROGRAM #PD07-09
RE: Abstract 3045: Zoledronate versus ibandronate comparative
evaluation (ZICE) trial - first results of a UK NCRI 1,405 patient
phase III trial comparing oral ibandronate versus intravenous
zoledronate in the treatment of breast cancer patients with bone
metastases.
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October 19, 2012
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Dear Dr. Barrett-Lee:
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Your abstract referenced above has been accepted for poster
discussion presentation at the 2012 CTRC-AACR San Antonio
Breast Cancer Symposium, December 4-8, 2012.
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•Dr Nick Murray Co-PI (Australia)
•Professor Timothy Maughan
•Dr Jacinta Abraham (VCC)
•Ms Sue Rees
•Dr Peter Simmonds (Southampton)
•Ms Sue Figueirido
•Professor Robert Coleman (Sheffield) •Ms Lucy Branston
•Dr Duncan Wheatley (Cornwall)
•Clare Boobier
•Dr Kerry Hood (SEWTU)
•Hayley Clements
•Mr Gareth Griffiths (WCTU)
•Bernadette Fuge
•Angela Casbard (WCTU)
•Catherine Roberts
•Professor Ceri Phillips
•Liz Merrifield
•Ann-Marie Nelson
• Athena Tsonis
•Sarah Townsend
•Members of IDMC and TSC
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