The UKCRC Registered CTU Network is committed to providing its members with the information, guidance and representation in order to successfully support member activities in high quality, efficient, effective and sustainable clinical trials research in the UK. A work programme has been developed in consultation with the UKCRC Registered CTU Working Group, funders and Registered CTU Directors.
UKCRC Registered CTU Executive Group:
Sarah Rudkin - Arthritis Research UK (Independent Chair)
Julia Brown – University of Leeds CTRU (Network Director)
Dean Chapman - Health & Social Care Research Wales
Liz Tremain - NIHR (England)
Alan McNair - Chief Scientist Office (Scotland)
Judith Bliss - Institute of Cancer Research Clinical Trials and Statistics Unit
Lorraine Smith - University of Edinburgh Clinical Trials Unit
Sarah Meredith - MRC at University College London Clinical Trials Unit
Cindy Cooper - Sheffield Clinical Trials Research Unit
Janet Darbyshire - International Review Panel Representative
Carrol Gamble - Statisticians Operational Group Chair
Sharon Kean - IS Operational Group Chair
Gill Booth - QA Operational Group Chair
Lelia Duley - Efficient Trial Conduct Subgroup Chair
Clare Morgan - NIHR CRN CC Representative
Paula Williamson - MRC Hubs Trials Methodology Research Network
Ian Walker - Cancer Research UK Representative
A work programme has been developed in consultation with the UKCRC Registered CTU Working Group, funders and Registered CTU Directors. Key work programme activities include:
1. UK Registration Process with review of currently registered Units based on an International Panel Review model and annual review of status.
2. 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 by exploring initiatives such as a directory of expertise and coordinated meetings in specific disease areas. This would optimise the use of the available expertise and reduce costs of the oversight of clinical trials. Networking will include biannual CTU Directors meetings, annual meetings for CTU Operational staff (Information Systems, Statisticians and Quality Assurance representatives, n.b. trial managers to meet within the NIHR trial Management Network infrastructure), 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.
3. Creation and support for the following Task and Finish Groups:
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.
b. 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.
c. Efficient Trial Conduct
Exploring new approaches and systems to improve efficient trial conduct. e. Operational themed meetings -Quality Assurance, Information Systems and Statistics in order to share best practice and to help develop standard approaches to common issues.
To explore different approaches to working with the insurance industry, to share experiences, seek best practice, and to campaign for better deals to cover both national and international clinical trials.
4. Representation of CTUs on national/ international groups and in national/international consultations
a. 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 eg the EU or MHRA will be collated and submitted.
5. Publicity for the UKCRC Registered CTUs
a. 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.
b. 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.
6. Focus for interaction with MRC Methodology Hubs Network and NIHR Research Design Services.