Collaborate with us

world mapIf you are planning a trial and would like to work with us, the steps below guide you through the process.

Timelines

We recommend you contact us as early as possible once you have decided to apply for funding as this enables a true collaborative approach to be employed during the grant application stage and ensures you have access to the expertise that is available within the LCTU.

N.B. In rare situations, an investigator may approach the LCTU once funding has already been secured where there has been no prior discussion with the trials unit. In these circumstances we will consider if this is a collaboration that can be supported using the process described below.

 

Stage One - Initial contact

The process of working with us starts with the completion of collaboration request form.  Email it to us, along with any other documents/information which may be useful to us in understanding your trial and your needs.

Your enquiry will be responded to at the earliest opportunity and initial discussions conducted between you and representation from our Senior Management team to determine if your application is potentially suitable for support. If your trial is something that we cannot support at this stage we will notify you and explain the reason for our decision. Further meetings will be held on an on-going basis, if your collaboration is considered to be a study the CTU can support.

 

Criteria for collaboration

  • At what stage is the submission? e.g. outline, full or already funded

We would expect to be involved at the earliest opportunity at outline or preliminary stage. If there is less than 8 weeks before the submission date, we may not be able to support the application even if it would qualify as being a high profile application for us

  • Does it contribute to the high calibre portfolio of activity LCTU undertakes?

We aim to have a portfolio that is mixed, high quality and supporting research that is answering important research questions

  • Is the investigator based at the University Hospitals of Leicester or the University of Leicester?

We welcome investigators outside of these institutions, but it does make the logistics and communication of managing a trial easier if the investigator is ‘local’.

  • Is it single or multi-site, randomised or non-randomised?

Our priority area is multi-site RCTs; however single-site trials will be considered based on whether or not it meets the criteria outlined in this section.

  • Is the funder the NIHR?

NIHR applications are one of our priorities, but we do consider other high calibre funders such as the MRC, major UK charities, EU or Investigator Initiated Industry studies.

  • Is it a pilot or feasibility?

If it is, we would expect a Research Design Service to have already been contacted, we can support pilot and feasibility trials but other factors outlined in this section would have to be met

  • Does it address an important research question which is a national or funder priority?

Trials that address important research questions for the funder and meet their priority areas have a better chance of being shortlisted and eventually funded.

  • What level of LCTU support is being requested?

Our preference is for full trial support which includes:

      • Design and methodology
      • Central co-ordination and management
      • Statistics
      • IT and data-management

We acknowledge that some teams have a great deal of in-house expertise and may not require full trial support. For investigators of the University Hospital of Leicester NHS Trust or the University of Leicester we will consider this request on a case-by-case basis. For collaborators from other Institutions we can only offer full trial support.

  • Does the LCTU have the necessary expertise to support the trial?

Our aim is to see a successful application come to fruition. If we feel an application will benefit more from a CTU with greater expertise in a specific area we will ‘sign-post’ to another more relevant CTU(s).

  • Does the LCTU have the necessary capacity to support the trial?

Our aim is provide adequate time and resources to work with investigators on their grant application. At certain times we can experience a ‘bottle-neck’ in terms of available capacity, especially around the time when grant submission dates are drawing close. This can sometimes impact on dealing with late requests to support applications.

  • Would the investigator be happy to accept and sign our 'Terms for Collaboration?

We would expect all investigators to sign and agree to our terms of collaboration as part of our acceptance to work together.

 

Stage Two - Initial LCTU collaboration discussion

The science behind the grant is often exciting but can sometimes dominate the initial meeting, leaving little time to obtain the key information we need to make a decision as to whether or not we cannot support the trial. Indeed it also provides you with the opportunity to consider, at that point, whether we are the right CTU for you.

Numbers in different coloursExample discussion areas:

    • LCTU role and collaboration
    • LCTU costing process
    • Confirmation of funder and submission deadlines
    • Involvement of other stakeholders – sponsor, RDS, CRN
    • Study overview or plan
    • Study timelines
    • Brief overview of trial design and methodology
    • Next Steps

You will be notified if your study is one that we can support.

Stage Three

If collaboration is agreed, the Terms for Collaboration will be signed by us and you.  Our aim is to always provide ‘full trial support’ which includes all of the key elements required to design and run a trial - design and methodology, statistics, trial management, IT, data-management and analysis.

people pie chartFurther meetings will be arranged during the application/protocol development process, which may include other potential collaborators including the East Midlands Research Design Services as applicable.   We need to be involved at this early stage to determine the level of LCTU collaboration, that the application is costed appropriately and that the study design and statistical analysis is appropriate to answer the outcome measures and research question(s).

Once LCTU input is confirmed, we will issue a Costing Letter, detailing the services to be provided and associated costs.

 

Stage Four - Funding approved

On receipt of the grant award, the LCTU will undertake the research activities as defined in the bid we helped to prepare and the CTU costing letter, and as applicable to the grant award specifications. A contract or service level agreement will be put in place before services commence

 

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