UCL Institute of Clinical Trials and 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 UCL 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

Read more about Methodology research at the MRC Clinical Trials Unit at UCL