- Posted By: Joanna Black
UKCRC Registered CTU Network held its bi-annual CTU Director’s meeting on Monday 10th Nov. The meeting started with an overview on activity presented by Prof Julia Brown (member of the Executive Group and Network Director): still brainstorming ideas of what needs to be in place when working with a Chief Investigator, but hopefully we can share some robust training material for common understanding. The board accepted the proposal for a 5 year cycle for re-registration and review of CTUs with the next one being in 2017 with a call for new registrations in 2015. In terms of raising the profile of CTUs, the international review panel are publishing a paper entitled “impact of registration of CTU: The UK experience” in the Journal of the Society for Clinical Trials. Over the year there had been two meetings with the Inspectorate division of the MHRA and they are now exploring the possibility of including network registration in the CTU risk algorithm, which is a real positive move for us. The focus and issues that the MHRA face are on computer systems, the use of eCRFs and the use of eTMF (especially when we work with international studies) and there are plans for the MHRA to meet with the relevant subgroups ie (IS group and STATS group).
The meeting was then followed by updates from the following sub-groups: QA (Joanna Black to give details after the meeting to be held later this month); Information Systems (see earlier blog by Sylwester); Statistics (see earlier blog by Sue Dutton). The ‘Efficient Trial Conduct’ group provided a report on a survey done in 2013 the aims of which were to identify inefficiencies during the two key stages of the trial conduct life cycle: from grant award to first patient and from first patient to publication. The 28-page report with results and conclusions is available on request from OCTRU. The group is working on a Template agreement between CTU and CI.
The insurance group reported on renegotiating the model non-commercial agreement to widen the scope of the insurance clause. This group would like to have in place a guidance document on insurance policies in different countries. There was a long discussion on who should cover insurance for DSMC members and other professions who cover independent reviews and the group take the view that this should be the Sponsor.
Elaine McColl reported that the ‘Core Infrastructure’ Group and ‘The Costings Model and Resource’ Group have now joined and the terms of reference are being revised. This group is now analysing the data on the survey that had been conducted on activities of CTU trying to understand what constitutes Core cost and what constitutes project specific costs. Preliminary results show that surprisingly the following activities are considered as Core: development of new studies till funding is in place; development and maintenance of SOPs; general non-specific training; general QA; cover for maternity/long illness breaks. This group is also looking (anonymously) at information provided on the Registration process for 2012 to try and find out from funders what is considered core. There is still a huge variation on job titles/roles/grades and may explain why when a CI shops around a trial is being costed differently by different CTUs. This group is also working on how to support PPI payments. The group for Industry reported problems with this group meeting as people keep resigning, but the group are working on a road map to advice CTUs on how to work with industry.
The next part of the meeting was a workshop and group discussion how the CTUs fit within their host institution, how the host institution helps or doesn’t and how the CTUs could adapt to changes. The main concerns that arose from this workshop were: academic recognition for key members of a CTU, career progression; different contract types for staff (academic vs research); financial insecurity example not enough resource in place to work up new trials, bridge gaps; also sponsorship in terms of whether a trial should be sponsored by the CI’s employer or the host institution of the CTU.
There was also an update from the Health Research Authority and the work they are doing to bring HRA approval in place which will remove the need for sites to do the current review process which will allow sites to focus more on the feasibility and set-up of the study.