Staff Profile:Professor Sue Todd

Name:

Professor Sue Todd

Job Title:

Professor of Medical Statistics

Responsibilities:

• School Director of Enterprise
• MSc in Biometry Programme Director
• Deputy Chair of the University Ethics Committee
• Member, School Postgraduate Board of Studies
• Internal Examiner, MSc in Biometry programme

Areas of Interest:

Research interests

• Group sequential clinical trials (including multivariate sequential analysis)
• Combining phase II with phase III clinical trials
• Adaptive designs
• Epidemiology

I am interested in methods of analysis following a sequential clinical trial, particularly the calculation of point estimates and confidence intervals. I am also interested in the development of methodology for the design and analysis of sequential trials involving treatment selection and where more than one endpoint is monitored. Linked with this is research into combined phase II/III clinical trials and adaptive designs. My research also includes consideration of methods for and results from analysis of baseline and follow-up data from large epidemiological studies.

Collaborative research

I am currently collaborating on six research grants. In conjunction with colleagues at Warwick Medical School and University of Goettingen, Germany, we are undertaking a project on "Using Surrogate Endpoints for Decision-Making in Adaptive Seamless Designs". A related project entitled "Adaptive seamless phase II/III designs - how should we interpret the results?" considers estimation issues in adaptive designs. In collaboration with colleagues in Food and Nutritional Sciences here at the University I am involved in several projects looking at "The effects of the substitution of dietary SFA with n-6 PUFA and MUFA on vascular function", "Influence of eNOS genotype on the vascular response to fish oil" and "Immunomodulatory effects of pre- and pro-biotics". A grant led by colleagues in Agriculture is considering "Reducing saturated fatty acids in the food chain through alteration of milk fat consumption".

Consultancy

I have been involved in the design and analysis of more than ten pharmaceutical sequential clinical studies. My experiences cover input into the design section of the study protocol, analysis of trial data, preparation of detailed documentation, presentation of work to companies and participation at investigators meetings. I have given seminars on my research to statisticians in numerous leading pharmaceutical companies and at conferences. I have been a member of eleven Data and Safety Monitoring Boards for international trials in cancer, intensive care medicine, hepatitis, heart disease and bone disorders.

Current teaching

• MSc: Data Analysis
• MSc: Clinical Trials
• MSc: Epidemiology and Public Health
• BSc: Data Analysis
• BSc: Clinical Trials

Research groups / Centres:

Publications:

Selected publications

Todd, S., Baksh, M.F. and Whitehead, J. (2011). Sequential methods in genetic epidemiology. Computational Statistics and Data Analysis (online)

Friede, T., Parsons, N., Stallard, N., Todd, S., Valdés-Márquez, E., Chataway, J. and Nicholas, R. (2011). Designing a seamless phase II/III clinical trial using early outcomes for treatment selection: an application in multiple sclerosis. Statistics in Medicine, 30, 1528-1540.

Chataway, J., Nicholas, R., Todd, S., Miller, D., Parsons, N., Valdés-Márquez, E., Stallard, N. and Friede, T. (2011). A novel adaptive design strategy increases the efficiency of clinical trials in secondary progressive multiple sclerosis. Multiple Sclerosis, 17, 81-88.

Matcham, J., Julious, S., Pyke, S., O'Kelly, M., Todd, S., Seldrup, J. and Day, S. (2011). Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry sponsored clinical trials. Pharmaceutical Statistics 10, 70-73.

Friede, T., Nicholas, R., Stallard, N., Todd, S., Parsons, N., Valdés-Márquez, E, and Chataway, J. (2010). Refinement of the Clinical Evaluation Scenario framework for assessment of competing development strategies with an application to Multiple Sclerosis. Drug Information Journal 44, 713-718.

Whitehead, J., Branson, M. and Todd, S. (2010). A combined score test for binary and ordinal endpoints from clinical trials. Statistics in Medicine 29, 521-532.

Whitehead, A., Whitehead, J., Todd, S., Zhou, Y. and Smith, M.K. (2008). Fitting models for the joint action of two drugs using SAS®.Pharmaceutical Statistics 7, 272-284.

Stallard, N., Todd, S. and Whitehead, J. (2008).Estimation following selection of the largest of two normal means.Journal of Statistical Planning and Inference 138, 1629-1638.

Siqueria, A.L., Whitehead, A. and Todd, S. (2008). Active-control trials with binary data: a comparison of methods for testing superiority or non-inferiority using the odds ratio. Statistics in Medicine 27, 353-370.

Todd, S. (2007). A 25-year review of sequential methodology in clinical studies.Statistics in Medicine 26, 237-252.

Baksh, M.F., Haars, G., Todd, S., Van Noord, P.A.H. and Whitehead, J. (2006). Comparing correlations of continuous observations from two independent populations using a sequential approach. Statistics in Medicine 25, 4293-4310.

Siqueira, A.L., Whitehead, A., Todd, S. and Lucini, M.M. (2005). Comparison of sample size formulae for 2x2 cross-over designs applied to bioequivalence studies. Pharmaceutical Statistics 4, 233-243.

Stallard, N. and Todd, S. (2005). Point estimates and confidence regions for sequential trials involving selection. Journal of Statistical Planning and Inference 135, 402-419.

Todd, S. and Stallard, N. (2005). A new clinical trial design combining phases II and III: Sequential designs with treatment selection and a change of endpoint. Drug Information Journal 39, 109-118.

Kelly, P.J., Stallard, N. and Todd, S. (2005). An adaptive group-sequential design for phase II/III clinical trials that select a single treatment from several. Journal of Biopharmaceutical Statistics 15, 641-658.

Baksh, M.F., Todd, S., Whitehead, J. and Lucini, M.M. (2005). Design considerations in the sequential analysis of matched case-control data. Statistics in Medicine 24, 853-867.

Whitehead, J and Todd, S. (2004). The double triangular test in practice. Pharmaceutical Statistics 3, 39-49.

Todd, S. (2003). An adaptive approach to implementing bivariate group sequential clinical trial designs. Journal of Biopharmaceutical Statistics 13, 605-619.

Stallard, N. and Todd, S. (2003). Sequential designs for phase III clinical trials incorporating treatment selection. Statistics in Medicine 22, 689-703.

Vincent, E., Todd, S. and Whitehead, J. (2002). A sequential procedure for comparing two experimental treatments with a control. Journal of Biopharmaceutical Statistics 12, 249-265.

Todd, S. and Sahdra, M. (2001). A case study of the effect of covariate adjustment in a sequential survival clinical trial. Journal of Biopharmaceutical Statistics 11, 297-311.