Transcript Work Programme (contd)

UKCRC Registered Clinical Trials Unit Network
Work Programme &
Future of the Network
CTU Directors’ Meeting, January 2012
Presented by Professor Paula Williamson
UKCRC Registered CTU Network
UKCRC Registered Clinical Trials Unit Network
What has happened since last meeting?
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Network administrator appointed June 2011, Saeeda Bashir ([email protected])
Funding agreed and received for 1 year from BHF, ARUK, NIHR, WORD, CSO
Working Group established, met twice
Membership:
Funders
– Sarah Rudkin, Arthritis UK (Chair)
– Michael Bowdery, Wales
– Tom Walley, NETSCC
CTU Representatives
– Julia Brown, Director UKCRC Registered CTU Network ([email protected])
– Paula Williamson, Director CTRC ([email protected])
– Rhiannon Whitaker, ([email protected])
– Adrian Bloor, Director ([email protected])
– Ian Ford ([email protected])
– Lorraine Smith ([email protected] )
– Janet Darbyshire
Clinical Research Network
– Jonathan Sheffield
UKCRC Registered Clinical Trials Unit Network
• Registration process developed with Working Group
– UKCRC umbrella agreed, competencies agreed, timelines
agreed, application form designed, workshop for new
applicants organised, international review panel convened,
date set for review
UKCRC Registered Clinical Trials Unit Network
• Membership fee structure developed
• Agreement for underwriting from key funders if required
• New website under development
• Newsletter, survey of Directors, Directors meeting, input into
consultations on behalf of network, MHRA/DoH/MRC Risk Assessment
Working Group
• Industry Interaction scoping group established – met once
– Rik Kaplan MRC CTU
– Rury Holman, Diabetes CTU
– Ian Ford, Glasgow CTU
– Jenny Gray, NCRN Industry lead
– Fiona Brain, NIHR CRN Industry lead
• Work Programme agreed with Working Group, CTUs and funders
UKCRC Registered Clinical Trials Unit Network
Work programme
•
UK Registration Process with review of currently registered Units based on an International
Panel Review model and annual review of status.
•
Networking opportunities between UKCRC Registered CTUs enabling:
– common approaches to addressing issues across Registered CTUs resulting in
optimisation of resources
– facilitation of shared best practice amongst Registered CTUs including mentorship of
developing CTUs resulting in increased quality systems and processes across the
Registered CTUs
– opportunities for CTUs to contribute to new developments and initiatives within the
clinical research community (funders, networks, and regulators)
– greater visibility of Registered CTUs providing easy access to information about their
expertise to other stakeholders, particularly funders and clinical investigators
– academic/industry partnerships to become more attractive resulting in increases in
collaboration
– development of more coordinated approach to the DMCs and TSCs
Biannual CTU Directors meetings, biannual meetings for CTU Operational staff (Information
Systems, statisticians and quality assurance representatives), continuation of existing
communication routes – JISC Mail, ‘The Exchange’ Newsletter. In addition a new interactive
website will be developed and maintained to facilitate information exchange between CTUs
for all disciplines and levels of staff.
UKCRC Registered Clinical Trials Unit Network
Work Programme (contd)
•
Creation and support for the following Working Groups:
– Industry
To explore frameworks for facilitating and publicising collaborations with industry and
small to medium enterprise and medical device companies. To share previous
experiences of working with industry to achieve greater transparency and consistency
into academic industry collaborations, addressing key issues such as IP and publications
policy.
– Core Infrastructure
A UK-wide review of Registered CTU core infrastructure funding with the aim of
mapping the availability of resources and expertise to support design and delivery of
clinical trials. Interaction with a range of funders and host institutions to publicise the
importance and benefits of core infrastructure funding in the delivery of cost effective
high quality clinical trials
– Costing Models
Development of a standardised approach to costing studies. The aim of this initiative is
to increase transparency, consistency and clarity in funding applications to assist both
applicants and funding bodies.
– Operational themed meetings -Quality Assurance, Information Systems and Statistics in
order to share best practice and to help develop standard approaches to common
issues.
UKCRC Registered Clinical Trials Unit Network
Work Programme (contd)
Representation of CTUs on national/ international groups and in national/international
consultations
– The Registered CTUs will be represented on key strategy and consultation groups (e.g.
MHRA GCP Consultative Committee, MHRA/DoH/MRC Risk Assessment Working Group,
NETSCC Trials Unit Advisory Group). CTU views on relevant consultations from national
or international bodies e.g. the EU or MHRA will be collated and submitted.
Publicity for the UKCRC Registered CTUs
– A dedicated online resource presenting a branded identity and showcasing the
Registered CTUs through an online directory of Registered CTU research interests and
contact details.
– Publicity material for funders, industry, small to medium enterprises, collaborators
which showcases the Registered CTUs and highlights the importance of and benefits of
engagement with Registered CTUs in terms of cost effective high quality delivery of
clinical trials
Focus for interaction with MRC Methodology Hubs Network and NIHR Research Design Services
UKCRC Registered Clinical Trials Unit Network
• What are CTUs getting from the network and the
work programme?
– Visible profile to facilitate access to and integration of UKCRC Registered CTUs
with key stakeholders, in particular research funders (including industry),
research networks, regulators, and investigators
– Raising profile with and understanding of our collaborators, funders, host
institutions
– Focussed contact point facilitating engagement with stakeholders and
ensuring CTUs have opportunity to contribute to key national initiatives and
developments (eg MRC Methodology Hubs)
– Efficiency and improvement in delivery through sharing best practice and SOPs
– Avoidance of duplication of effort and standardising systems (e.g DIMs)
– Peer support for common issues (SharePoint; JISCmail)
– External recognition of quality – eligibility for new funding initiatives (e.g.
NIHR CTU Pump Priming Funding)
– Collaborative approach to addressing national issues (e.g. CTU capacity)
– Networking with UK CTU Directors, for statisticians, IS, QA
– Representation at national / international level
– Mentoring (if required)
UKCRC Registered Clinical Trials Unit Network
Funding model
– Upfront fee for registration review (£500)
• Review every 3 years with annual self assessment sign
off
– Annual fee to cover work programme
• Amount to be adjusted depending on outcome of
registration process
• Likely to be around £2,000 per annum
– Lean structure to keep costs down
• Reviewed by working group
UKCRC Registered Clinical Trials Unit Network
• Next 6 months a lot of focus on registration process
• Development of new interactive website
• Then move to establishing Sub Groups
– Propose 10 members
– Invite applications – review by Working Group
UKCRC Registered Clinical Trials Unit Network
2012 Registration Process
– Key dates for review
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Application process open Jan 2012
Deadline for completed applications 6 April 2012
Review early July 2012
Outcome September 2012
– Application form available from website
– Key differences
• Simplified
• Section 1 Overall summary
– Details of 5 (3) open, in follow-up, analysis multi centre rcts, 1 in
NIHR portfolio, at least 2 (1) open
– 3 (1) trial publication of existing/closed trial - front page of each
showing author contributions
UKCRC Registered Clinical Trials Unit Network
2012 Registration Process
• Section 2 Staffing
• Overall staffing, cvs of 2 (1) statisticians,2 (1) trial/project
managers, 2 (1) IT person(s)
• Section 3 Infrastructure
– Statement of support from host institution
– Details of how you ensure long term continuity
• Section 4 Quality Assurance
– List of Essential SOPs (8 new, deviations and serious
breaches, urgent safety measures, sponsorship, system
validation, database development, database change
management, business continuity and disaster recovery)
– How you manage quality assurance, risk assessment and
monitoring
UKCRC Registered Clinical Trials Unit Network
2012 Registration Process
• Section 5 Information Systems
– How data is collected
– Info on database systems and their management
• Section 6 Extent of availability
• Section 7 Signatures
• Section 8 Collaborative Group information
UKCRC Registered Clinical Trials Unit Network
International Review Panel
Clinical epidemiology
Clinical Trials Unit Director
Experienced triallist
Information Systems
Trial Management
Statistics
Funder/ triallist
Statistics
UKCRC Registered Clinical Trials Unit Network
UKCRC Registered Clinical Trials Unit Network
Application/Registration
International Review
Panel
Travel and accommodation
Cost per unit
Number of units
TOTAL cost
13200
1
13200
120
9
1080
45
16
720
3498
1
3498
IT/IS Consultant
500
1
500
Website set up
500
1
500
2188
1
2188
0.1
17000
1700
Subsistence (4 nights)
Meeting
Venue - should be free
Food * 3 days
Admin
Temp for collating info
based on 58 Apps
3 months 60% Grade 4
General
Graphic Designer 1 month
(Forms/Promo Material)
Printing costs
Subtotal
23386
UKCRC Registered Clinical Trials Unit Network
Annual costs to be multiplied by 3
Meetings
Director meeting Venue, Food
Promotional costs
Website cost per year
Admin support 30% Grade 4
Working Group Meetings *4 per year
Venue free
10 people Food
7 people Travel
Teleconference (10people @25pp/pm)
Admin
Network Coordinator
Travel expenses
Director's time to oversee @ 3%
Sub Group Meetings *2 per year
Extra meetings Sub Groups (x4 groups):
Venue free
10 people food
Travel 10 people
Teleconference (10people @25pp/pm)
Operational Themed meetings (IS/STATS/QA):
Food up to 20 people per group
Travel for 20 people
Subtotal
Cost per
unit
Number of units
TOTAL cost
4000
1000
4000
6921
2
1
1
1
8000
1000
4000
6921
0
150
1400
225
0
2
2
2
0
300
2800
450
38158
1000
3025
1
1
1
38158
1000
3025
0
150
1000
225
0
2
2
6
0
300
2000
1350
300
2000
3
3
900
6000
76204
TOTAL
251998
UKCRC Registered Clinical Trials Unit Network
Questions?