Collaborating with the Manchester Clinical Trials Unit Ian Emerson Svet Mihaylov
Manchester CTU Background • Formed 2008 within the Christie NHS Foundation Trust, as the Christie Trials Coordination Unit • Gained UKCRC registered trials unit accreditation that year • Became MAHSC-CTU 2012 Formally transferred to the University of Manchester 1 st April 2018 • • Rebranded as Manchester Clinical Trials Unit (M-CTU) June 2018 Physical move from the Christie campus to FBMH premises 1 st August 2018 • Manchester Clinical Trials Unit
Manchester CTU Portfolio • 6 trials in set-up • 19 trials recruiting • 7 trials in follow-up • 7 trials in analysis • There have been 19 of our trials published in the last 5 years • Current portfolio spread across 10 sponsors, 8 within the North West (Christie, UoM, Salford, GMMHFT, MFT South, MFT Central, Lancashire Care NHSFT) Manchester Clinical Trials Unit
Working with Manchester CTU Manchester Clinical Trials Unit
Requesting Support • If you have any initial enquiries regarding a collaboration with us, please email our Director, Professor Kevin O’Brien. • We recommend that you contact us at the earliest stage of your study design to start discussions. This should also be at least 12 weeks in advance of your grant submission deadline • This allows us to provide advice, liaise with the study sponsor, and develop an accurate costing of our work. • Alternatively, follow the link to our website, containing all information on requesting support; www.manchester.ac.uk/ctu Manchester Clinical Trials Unit
First Meeting • An initial meeting will be arranged with you, involving appropriate Directors/ Methodologist, and/or relevant M-CTU staff • A decision will be taken whether your request will progress to the next stage, or whether we feel you require additional design and methodology input first • If you are to progress, M-CTU will provide a collaboration form to complete Manchester Clinical Trials Unit
M-CTU Collaboration form • This form will enable the M-CTU Directors to decide whether to adopt the trial • All sections of the form should be completed, with as much accuracy as possible • Completed form returned to MAHSCCTUSupportRequests@christie.nhs.uk • If available, include the study protocol (early draft is fine) • The directors will decide whether to adopt the trial into the portfolio or not • If yes we will proceed to costing the proposal, followed by submission Manchester Clinical Trials Unit
Costing M-CTU Activity • We will work with you and the sponsor to determine the cost of resources for the required CTU service: − relevant CTU team leads will provide activity estimate, or − CI could be invited to informal discussions − Resource estimate will be sent to the RSM • We will work with you until the research proposal is submitted, this may involve input from: − appropriate Directors/methodologists, − and/or relevant CTU staff Manchester Clinical Trials Unit
Post Application • Investigators must provide copy of funding application to M-CTU • If an expression of interest or outline proposal progresses to full application, the MAHSC-CTU Directors will assess any significant changes (i.e. sample size, number of cohorts, trial duration) made to the study since the initial proposal. • Where the funder review panel has asked for changes to trial design, M-CTU should be notified as soon as possible in order to provide feedback within deadlines. • M-CTU will work with the Investigator where required in order to provide a robust response to funder reviews • Signification changes include all areas that may impact resources and subsequently the MAHSC-CTU • For failed bids, M-CTU retains details of all requests for collaboration Manchester Clinical Trials Unit
Post Award • Following a grant award recommendation, a meeting will take place between M-CTu and Investigator team to confirm whether the trial has significantly changed, and to finalise the timeline of the project, costs and deliverability. • Trigger for M-CTU to commence operational support is signature of funding contract / generation of “R” code • We may decline to manage the study if there have been major changes to the design and/or funding. Manchester Clinical Trials Unit
Tips for successful collaboration • Approach M-CTU at least 12 weeks prior to deadline, particularly if input needed from Methodology or Health Economists • Where external methodology input has been included, we need to know who this was to enable us to laisse with them • Provide as much detail as possible on the Request for Collaboration form • Let us know feedback form funders as soon as possible to enable us to provide a timely response • Please do not make changes to trial design or M-CTU costings without discussing with us Manchester Clinical Trials Unit
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