Methodological Research Cancer Division

The Cancer Division has a wide variety of ongoing methodological research, including novel ideas generated to deal with methodological issues arising from specific projects within the Cancer Division, as well as more generic new methodological approaches intended to apply across the board in the cancer field.  The research benefits from being embedded in one of the foremost academic trials units in the UK, with particular focus and expertise in cancer, and with a wide portfolio both of active trials, and of those still under development.  The research is therefore always of direct and practical use, and appropriate applications are readily forthcoming.

Some of the major areas of methodological research are as follows:

  • Design and analysis of trials intending to add an arm as the trial is ongoing
  • Defining the choice and optimising the size of Phase II trials
  • Analysis and novel design approaches incorporating surrogate outcomes in clinical trials
  • Mathematical/statistical modelling which quantifies residual disease and its regrowth after treatment in cancer trials: including analysis, trial design, sample size and monitoring.
  • Appropriate analysis of cut-points for prognostic variables in clinical trial data
  • Adjusting survival curves to remove the confounding effects of subsequent therapy
  • Sample size and trial design for trials involving interventions based on the value of a biomarker used for monitoring
  • Trial Designs for trials with QALYs as a primary outcome measure
  • Development and use of patient reported outcome measures

A variety of other methodological projects include trial designs that allow for ‘contamination’ in one or more of the arms, and novel trial designs based on response surface or hill-climbing approaches.

Results are discussed and presented at regular, weekly, methodology meetings within the CTRU, as well as externally through journal publications, and via presentations/posters presented at a wide range of conferences, both local, national and international, as well as through invited talks at other trials units and universities.  The methodology team interacts with its peers, both in other trials units, and internally at Leeds with the Department of Mathematics, Department of Biostatistics and the Leeds Institute of Health Sciences.