Statistics

KCTU provides statistical collaboration via the IoPPN statistics group for mental health trials and the FOLSM statistics group for all other disease areas.

Statistical input into research is vital to ensure that data is robustly collected and analysed, thereby providing reliable results which are publishable in high impact journals. King’s CTU provides three levels of statistical collaboration.

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If statistical collaboration is requested, the support request should be submitted well in advance to allow sufficient time for statistician to review the project before grant submission.

Standard Collaboration

This level of collaboration is most useful for UK based single centre or multi-centre studies with a standard size database, i.e. where the number of variables and the sample size are both typically smaller than 500. In general, there are less than 10 centres and centres are teaching institutions/ experienced in research, or are within sufficient proximity such that central statistical monitoring is not deemed to be required, as on-site monitoring visits can feasibly be undertaken.

Resource required

  • 25% Junior statistician to be costed into the grant application
  • 5% Senior statistician supervision to be costed into the grant application

Advanced Collaboration

Feasibility Collaboration

More details of the levels of collaboration can be found in the following table.

  Standard Advanced Feasibility
Develop the design for a clinical trial or other study including assisting in the preparation of the study protocol
Respond to reviewer’s comments
Prepare sample size calculation (optional)
Advise on randomisation method  
Advise on the preparation of case report forms (CRFs)
Prepare DMEC/TSC reports (~1-2/Year) (optional)
Provide central statistical monitoring (requiring additional data exports approx. every 1-2 months)    
Write the statistical analysis plan in collaboration with the CI  
Attend a proportion of TMG meetings   (optional)
Attend regular TMG meetings    
Prepare code for primary analysis (primary publication)
Prepare code for one secondary publication (e.g. mediation analysis)    
Contribution to production of reports to funders (creating CONSORT & Recruitment charts)    
Assume standard size dataset with moderate number of secondary outcomes    
May analyse large dataset, and include mediation and/or moderation analyses    
Conduct primary analysis for primary paper (Inc. primary analysis code checks) (descriptive)
Conduct secondary analysis for one secondary paper    
Prepare statistical report and contribute to writing of the primary paper
Contribute to writing of one secondary paper    
Advise on the development of study to a definitive trial