the leicester ctu...getting the best from the ctu seek advice and support early allow time for...
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The Leicester CTU
Added value!
What is a CTU?
A specialist unit set up with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies
To ensure standards required by regulatory authorities
High quality trials management expertise and capacity within CTUs are key to supporting the development of research activity within the UKCRC and the clinical research networks
www.ukcrc-ctu.org.uk
UKCRC registration
Full registration - awarded to CTUs• that demonstrate a track record of coordinating multi-centre RCTs or
other well-designed studies
• with a core team of expert staff to develop studies
• with robust quality assurance systems and processes to meet appropriate regulations and legislation
• providing evidence of longer-term viability for maintenance of a trials portfolio
Provisional registration• Awarded to newer and evolving CTUs with relevant expertise and
experience worth building on
www.ukcrc-ctu.org.uk
The Leicester CTU
www.le.ac.uk/ctu
Dr W D Toff Director
Karen Smith Principal
Statistician
John Brookes
Senior Medical Statistician
Linda Porter Operations
Director
Laura Carrick Administrator
Jackie Stanley Finance
Assistant
Danny Kirby IT Manager
Jennie Lucas Senior Data
Manager
Data Manager (tba)
Data Entry Clerks x2
Matt Peck Computer
Officer
Clinical Trials Unit
CTU MOG
CTU Steering Committee
RSMOG
Research Sponsorship Committee
Sponsor College of MBS&P
Leicester CTU oversight
CTU expertise and capability
How does the CTU select projects to support?
College core funded Unit• University investigators/grant holders
• University sponsored trials
• College research strategy
NIHR CTU support funded Unit• NETSCC funding streams
Other funding• Other NIHR
• Charity
• NHS Trusts
http://www.netscc.ac.uk/index.asp
Funders – NIHR (NETSCC)
NIHR
• National Institute for Health Research
NETSCC
• NIHR Evaluation, Trials & Studies Coordinating Centre
NETSCC manages four evaluation research programmes - Efficacy and Mechanism Evaluation (EME) - NIHR Health Technology Assessment (HTA) - NIHR Public Health Research (PHR) - NIHR Health Services and Delivery Research (HS&DR)
http://www.netscc.ac.uk/index.asp
NIHR - Central Commissioning Facility
OPEN CALLS
NIHR Invention for Innovation (i4i)
NIHR Research for Patient Benefit (RfPB)
NIHR Programme Grants for Applied Research
NIHR Programme Development Grants
DH Policy Research Programme
www.nihr-ccf.org.uk/site/default.cfm
Why use a CTU? (1)
Established processes & key roles
quality assurance
statistics
operations
project management
data management
information systems
Why use a CTU? (2)
SOPs Infrastructure for multi-site (& speedier) studies Trial management support for admin burdenData validity Support for TSC and IDMC Speed of database lock – publication – change in
medical practice Regulatory changes Inspection support
Why use a CTU? (3)
Data Management and Statistics• Feasibility questions to establish recruitment rates and
number of sites required
• Monitoring of target v actual recruitment rates at [monthly] trial meetings
• Monitoring of safety, endpoints, consistency and compliance and timely data returns
• Interim / final analysis
• At end of trial, writing statistics report and input to publication
How to Approach the CTU
Contact the CTU via the website www.le.ac.uk/ctu or email [email protected]
• As soon as you have a clear research idea
• Ideally 3 - 6 months before the grant application deadline, although we accept that commissioned calls often have a shorter deadline
What will the CTU need?
Draft protocol or funding outline
Plans for funding submission
Appropriate data to enable trial design
• Outcome variable(s)
• Estimates of variability
• Size of desired effect
Any information relating to feasibility of proposed study
Getting the best from the CTU
Seek advice and support early
Allow time for deadlines
Have a clear idea of what the trial is to achieve
Don’t be afraid of constructive criticism – better from the CTU than the funder!
Contact details: www.le.ac.ukEmail: [email protected]