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Pragmatic Clinical Trials Unit

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What sort of projects will the PCTU collaborate in?

We collaborate in clinical trials and other “well designed” research projects, this includes pilot and feasibility studies, observational studies, and systematic reviews. The ICJME defines a clinical trial as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

Find out more about how collaboration with the PCTU works for different types of study

What do I need to do?

Contact the PCTU as soon as you can, preferably early in the planning of your study. Staff within the PCTU have extensive experience of designing, conducting and analysing trials. If your request for collaboration on a project is accepted we will provide input to your funding application in a range of areas in order to give the application the best chance of funding success. This can include design and analysis, trial management, data management, quality assurance, health economics, and practical and logistic issues.

In order to make sure that staff can give appropriate and timely input it is best to approach the PCTU as soon as possible in your study planning and, in any case,  a minimum of 12 weeks before the submission deadline. In case of multi-stage application processes, this deadline applies to the first stage of the application.

Contact us on PCTU-enquiries@qmul.ac.uk with an initial query regarding collaboration, detailing the following:

  • (i) project outline
  • (ii) intended funder and funding stream
  • (iv) proposed chief investigator; and
  • (v) submission deadline.

Please also forward to us any documents that may support your aims and objectives, if available. 

We may be able to make exceptions to the 12-week notice period for some commissioned calls with shorter deadlines. However, please contact the PCTU Administrator on the email above with as much notice as possible.

If you wish to speak to someone informally about your enquiry please let us know via PCTU-enquiries@qmul.ac.uk and that can be arranged.

What happens after I have made the initial enquiry?

Your email is forwarded to the PCTU management group. This group will take a decision on whether to collaborate or not. You should expect a decision within 5 working days, provided there are no queries about your enquiry.  

This decision will be based on staff capacity (near to some funding deadlines, the unit receives a lot of requests and cannot say yes to all of them); how closely the study aligns with the PCTU clinical and methodological interests; the likelihood that a strong application will be ready for the funding deadline; study risk; and for a trial- whether it is pragmatic or not. When capacity is an issue the unit prioritises applications being submitted to the NIHR, and those in which senior PCTU staff have had significant involvement.

If the management group accept the collaboration, a statistician will be assigned to your project and they will contact you to discuss the design of your study. These discussions will involve others, for example health economists and data management, trial management, and quality assurance staff as appropriate. About six weeks prior to the funding deadline we will provisionally agree PCTU staff input to the study and review and finalise costings with you.

If the management group do not support the collaboration, a senior member of staff will be available to explain why your study was rejected and, if appropriate, how the unit might be able to work with you in the future.

 

 

 

 

 

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