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¹û¶³Ó°Ôº Institute of Clinical Trials and Methodology

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Methodology

A priority of the Institute is the development of methods which have a direct impact on the design, conduct or analysis of our or other people’s studies. The MRC CTU at ¹û¶³Ó°Ôº is conducting the majority of the research into trials methodology, and their work is presented in three themes:

Design of trials, meta-analyses and observational studies
  • Multi-arm, multi-stage (MAMS) platform trials
  • Designing phase II (and III trials) based on an enhanced decision process at the end of phase II
  • Improving the design of stratified medicine trials and biomarker validation studies
  • Designing trials in uncommon diseases
  • Cluster randomised and stepped wedge trials
  • A flexible framework for complex time-to-event outcome trials
  • Planning and accounting for missing data
  • Improving the analysis and design of trials with longitudinal data or clusters of varying size
  • Designing trials with recurrent events as the primary outcome measure
  • Re-randomising patients into trials
  • Design, development and validation of prognostic models
Effective and efficient conduct of trials and meta-analyses

Trial conduct methodology:

  • Providing practical examples of how novel designs can be implemented
  • Evaluating and implementing strategies to ensure that data on randomised patients is not lost through patient withdrawal
  • Efficient trial monitoring
  • Getting trials started more quickly, and facilitating prompt reporting of outcome data

Meta-analysis conduct methodology:

  • Speeding up the evaluation of individual therapies in meta-analysis
  • Providing tools and guidance to promote greater awareness, understanding and use of IPD meta-analysis
  • Resolving outstanding issues in systematic review conduct
Analysis of trials, meta-analyses and observational studies
  • Analysing multi-arm multi-stage (MAMS) trials
  • Analysing time-to-event outcomes
  • Multivariable prognostic models and treatment-covariate interactions (including validation)
  • Appropriate analysis of longitudinal and clustered data
  • Causal models for answering questions not addressed by randomisation
  • Missing data and improved sensitivity analysis for missing outcome data
  • Design, development and validation of prognostic models