Forthcoming MPS Research Unit courses to be held at the University of Reading, UK


Statistical Methods for Ordered Categorical Data

3 days

Presenters Kim Bolland and John Whitehead 

6-8 March 2006


Ordered categorical data arise from many clinical trials and epidemiological studies.  Commonly used scales include the Glasgow Outcome Scale in head injury, where the five response categories are Good Recovery, Moderate Disability, Severe Disability, Vegetative State and Death; the Barthel Index and modified Rankin score in stroke; the Expanded Disability Status scale in multiple sclerosis as well as various measures of quality of life.  This course examines the design and analysis of studies in which the primary response is of this form.

Binary data are a special case of ordered categorical data and the course first reviews the statistical methodology for binary data, with an emphasis on logistic regression analysis.  The generalisation from binary to ordinal data is based on the assumption of proportional odds, and for a simple comparison of two homogenous groups the method leads to the Mann-Whitney test.  Linear modelling and model checking are given prominence.  Calculation and review of sample sizes are examined, together with other design issues.  Methods for the analysis of repeated ordinal data based on the marginal model and on the subject-specific model are presented and compared. 

The course is extensively illustrated using examples drawn from the presenters' consultancy experience.  Many practical sessions are included, most of which involve using SAS.

Programme

* Review of binary data analysis
* The proportional odds model
* Fitting linear models using PROC LOGISTIC
* Model checking
* Alternative models
* Ordinal data and clinical trials
* Sample size and power
* Repeated ordinal data



Sample Size Determination in Clinical Trials

2 days

Presenters  Anne Whitehead and Mark Simmonds

9-10 March 2006


At the planning stage of a clinical trial a key question is "How many patients do we need?" For a superiority trial the main objective is to provide evidence of superior efficacy for the new therapy relative to the control.  This requires a sample size that ensures sufficient statistical power to detect a clinically relevant improvement. Equivalence or non-inferiority trials require sample sizes that establish with sufficient confidence that the new therapy is respectively equivalent to or no worse than the control.

This course provides a framework for sample size determination in superiority, non-inferiority and equivalence trials. It considers a general parametric approach applicable to binary, ordinal, time to event or normally distributed patient responses. Comparisons are made with other commonly used approximate and exact methods.  Both parallel group and cross-over designs are considered.  Extension to more than two treatments is also discussed. Practical aspects such as allowance for drop-outs, protocol violations and mid-trial sample size reviews are addressed.  The course includes practical sessions involving the use of hand calculators and training in software packages such as nQuery Advisor and PASS. 

Programme

* A general parametric approach to sample size calculations
* Binary, ordinal, time to event and normally distributed data
* A unified approach to superiority, equivalence and 
        non-inferiority trials
* Parallel group and cross-over designs
* Designs with more than two treatments
* Practical and ethical considerations


Fees

For bookings made 6 weeks or more prior to commencement of the course the following reduced fees apply

Students 
360 pounds for 2 day course
540 pounds for 3 day course

Sponsors/Publicsector/Academic
450 pounds for 2 day course
675 pounds for 3 day course

Other 
510 pounds for 2 day course 
765 pounds for 3 day course

For bookings made less than 6 weeks prior to commencement of the course the following fees apply
600 pounds for 2 day course 
900 pounds for 3 day course

The course fee includes all supporting documentation, refreshments and lunches.  For a course running more than one day, dinner is included on the first evening.

Cancellation: Registrations are transferable to another course or individual at any time, otherwise cancelled course registration will incur the following charges:

 11 - 20 days before the start of the course 50%
 1 - 10 days before the start of the course 90%
 course start date or later 100%.

We reserve the right to cancel any course without liability other than a refund of the course fee.  

Location

Reading, UK  is situated on the River Thames, 40 miles west of London.  The town is easily accessible from Heathrow airport (45 mins) by regular coach service or taxi.  Courses take place at Whiteknights Park, a spacious and attractive campus of the University of Reading, 3 miles from the town centre.


For further information please contact

 Barbara Dodds
 MPS Research Unit
 The University of Reading
 PO Box 240, Earley Gate
 Reading RG6 6FN, UK.

 Tel:  +44 118 378 6662
 Fax: +44 118 975 3169

 E-mail: [log in to unmask]

 http://www.reading.ac.uk/mps