Randomised Controlled Trials Course:
a guide to design, conduct, analysis, interpretation and reporting
24th November – 27th November 2009
Ho Chi Minh City, Vietnam
About the course
This course provides a thorough grounding in the principles and practice of randomised controlled trials (RCTs) for the evaluation of healthcare interventions. It will include talks and practicals to give examples and guidance on the methodology of trials using a problem-based learning approach.
Course objectives
- Clarify fundamental principles and practice of RCTs
- Demonstrate the optimal methodology to use in RCTs based on considerable practical experience and using extensive examples from the literature
- Examine the critical issues involved in planning, conducting and completing a successful trial
- Provide a basic understanding of statistical input into RCTs including analyses frequently used
- Facilitate critical appraisal of published reports of RCTs
Who should attend
The course is aimed at persons planning or actively involved in trials, or individuals interested in furthering their knowledge of trial methodology. Applications are invited from clinical and non-clinical researchers and other professionals allied to medicine.
Course tutors
The main speakers/course tutors (all Oxford based) include the following:
Prof Doug Altman, Director, Centre for Statistics in Medicine, University of Oxford
Prof Mike Clarke, Director, UK Cochrane Centre
Ed Juszczak, Head of Trials, National Perinatal Epidemiology Unit, University of Oxford
Ly-Mee Yu, Senior Medical Statistician, Centre for Statistics in Medicine, University of Oxford
Course outline
Introduction – Introduction to evidence
Design
Defining the research question
Protocol development
Principles and practical aspects of randomisation, allocation concealment, blinding & maximising follow-up
Choice of study population, intervention & comparison group
Outcomes
Alternative trial designs
P values & confidence intervals (Estimation & hypothesis testing)
Sample size & power
Trial conduct
Data collection & management
Avoidance of bias
Data monitoring & interim analysis
Data analysis
Estimating treatment effects for binary, continuous & survival data
Baseline comparability
Statistical adjustment
Missing data
Multiplicity
Subgroup analysis
Alternative trial designs
Interpretation & Reporting
Interpretation of trial findings
When is a conclusion of equivalence possible?
Importance of transparent reporting of trials – the CONSORT Statement
Small group sessions
Throughout the course, in small groups, participants will discuss examples of RCTs for a given intervention.
Application details
Date and times
Tuesday 24th November to Friday 27th November 2009; registration on 24th November is at 8:30am. Typical day runs from 9am to 5:30pm.
Venue
The course will be held at Oxford University Clinical Research Unit, Hospital for Tropical Diseases 190 Ben Ham Tu, Dist. 5, Ho Chi Minh City, Vietnam.
Accommodation
Hotel rate in Ho Chi Minh city is 100 usd/ single room/ person/ night. Cheaper accommodation may be available on request.
Course fee
1,700 usd/ person
Fees include daily lunch and refreshments, dinner, transportation to and from OUCRU, a comprehensive delegate’s pack including all course materials, and a choice of book.
Application form
Please complete and return the application form and we will review it and let you know if we can offer you a place. Priority will be given to persons planning or actively involved in trials. Registrations are not transferable.
Places are strictly limited to 40 participants, and you are advised to apply early.
Click here to download the application form.
To apply
Please send, fax or email application forms by 15 October 2009 to: Tracy Edwards, Centre for Statistics in Medicine, Wolfson College, Oxford, OX2 6UD, Fax: +44(0)1865 284424
And Ms Ngoc Anh OUCRU-VN
Email: tracy.edwards@csm.ox.ac.uk & anhttn@oucru.org
