Leicester Clinical Trials Unit

Criteria for collaboration

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

LCTU would expect to be involved at the earliest opportunity, whether this is at the preliminary stage or at outline. Should there be fewer than 8 weeks before the submission date, LCTU may be unable to support the application even if it would qualify as a high profile application.

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

LCTU aim to have a portfolio that is high quality as well as supporting research that answers important clinical questions.

Is the investigator based at the University Hospitals of Leicester (UHL) NHS Trust or the University of Leicester?

LCTU very much welcome investigators who are based nationally or local to Leicester.

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

LCTU's priority area is multi-site Randomised Controlled Trials (RCT); however, a single-site trial 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. However, LCTU 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 trial?

If it is, LCTU would expect a Research Design Service to have already been contacted. LCTU 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?

LCTU's preference is for full trial support which includes:

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

It is acknowledged that some teams have a great deal of in-house expertise and may not require full trial support. For investigators of the University Hospitals of Leicester NHS Trust or the University of Leicester, LCTU will consider this request on a case-by-case basis. For collaborators from other Institutions only full trial support can be offered.

Does LCTU have the necessary expertise to support the trial?

LCTU's objective is to see a successful application come to fruition. If it is felt an application will benefit more from a CTU with greater expertise in a specific area you will be sign-posted to a more relevant CTU(s).

Does LCTU have the necessary capacity to support the trial?

LCTU's intention is to provide adequate time and resources to work with investigators on their funding application. At certain times there may be a ‘bottle-neck’ in terms of available capacity, especially around the time when funding application 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'?

LCTU would expect all investigators to sign and agree to the terms for collaboration as part of the acceptance to work together in partnership.

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