UKCRC Registration: UKCRC Registration: What it may mean for Exeter?What it may mean for Exeter?

Rod Taylor

ECTSN Meeting, 15th Sept 2014

o The aim of this process is to help improve the quality and quantity of available expertise to carry out clinical trials in the UK.

o To gain UKCRC Registration, need to demonstrate:o a track record of experience in coordinating multi-centre trialso expert staff to develop studieso robust quality assurance systemso evidence of long term viability of capacity for trials coordination

In 2007 the UK Clinical Research Collaboration UKCRC developed a registration process which recognises Clinical Trials Units that have the expertise to centrally coordinate high quality multi-centre clinical trials.

UKCRC Registration Process I

UKCRC Registration Process II

• Rounds– March 2007; Spring 2009; March 2012; Spring 2015

• Applications from any CTU in UK responsible for design, conduct and analysis of multi-centre RCTs or other well designed studies

• Individual CTUs and collaborative groups eligible to apply

• Any disease area/topic

Task and Finish Advisory Panel

• Rod Taylor – (Chair) Acting Unit Director

• Gill Baker – Unit co-Director

• Tim Eames

• Dave Richards

• Sarah Dean

• William Henley/Fiona Warren

• Colin Green/Anne Spencer

• Charlotte Moger

• Nick Church

• Paul Ewings

UKCRC Registration Process III

• Two levels of registration offered:– Full

• Track record in design, conduct and analysis• Presence of core team of expert staff• Robust QA systems• Long term viability

– Provisional• Developing expertise but currently falls short of full

complement of infrastructure, resource and experience for full registration

Current43 Full 2 Provisional

UKCRC Registered Clinical Trials Unit Network

2015 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

2015 Registration Process

• Section 5 Information Systems– How data is collected– Info on database systems and their management

• Section 6 Statistics• Section 7 Extent of availability• Section 8 Signatures• Section 9 Collaborative Group information

UKCRC Registered Clinical Trials Unit Network

2012 - International Review Committee Issues

– Data management systems sub optimal• Use of MS Access strongly discouraged• Need for formally validated systems

– Quality management required development• Key SOPs missing• Quality Assurance required development• Audit systems required development• Risk assessment required development

– Need for local collaboration between Units– Need for clarity on organisational arrangements and staff structures

NIHR Clinical Evaluations & Trials Support Funding

► Twenty units funded via two funding rounds► Three year rolling contracts► Three funding bands:

► £150, 200, 250k

► All payments to be directly to CTUs► Up to 80% of funds to be recovered after grants awarded► Recovery by reduction in subsequent support funding payments► Research project grants are unaffected

What it may mean for Exeter?

• Recognition and profile

• Local CTU support & signoff for funding bids

• Drive future resourcing– University of Exeter core funding of additional

posts– NIHR infrastructure funding

• Join ‘the UK CTU club’