Presented by Steven A. Julious Steven is a Professor of Medical Statistics at The University of Sheffield but through his career has worked in both the academic and pharmaceutical sector and is a former editor of the journal Pharmaceutical Statistics. He has an interest in applied methods for clinical trials and has a particular interest in clinical study design and sample size estimation. He has written two books one on early phase trials and one on sample size estimation and has also developed an App called SampSize for the estimation of sample sizes.
About the course: The three most important aspects of a clinical trial are: design, design and design. A sample size estimate is just one aspect of a clinical study design.
The course describes calculations for sample size estimation in the design of clinical trials. It will be highlighted how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.
The following topics will be covered:
Introduction to Key Concepts
- Type I error
- Type II error
Sample Sizes for Different Clinical Trial Objectives - Superiority
- Precision based
- Pilot studies
Sample Sizes for Different Types of Data - Normal
Clinical Trial Designs - Cross-over
- Parallel Group
How Design Considerations Impact on the Sample Size - Baselines/covariates
- Multiple endpoints
Other Considerations when Designing a Trial - Sensitivity analysis
- Optimising variance estimates
Considerations which Impact on the Sample Size - Adaptive designs for efficacy
- Assessing futility
- Sample size-re-estimation
Course runs from:
10:00 – 17:30 (registration from 9:30) on Day 1
09:00 – 16:30 on Day 2.
Registration costs (includes lunch and refreshments)
Before 30th May 2017
£495 + VAT
£570 + VAT (includes PSI membership for 1 year)
After 30th May 2017
£595 + VAT
£670 + VAT (includes PSI membership for 1 year)
PSI are holding a limited number of hotel rooms at an extra cost until the 30th May 2017 which will be allocated on a first come first served basis. Please contact the PSI Secretariat for more information.
Registration for this course has now closed.
Joint PSI, EFSPI & ASA BIOP Webinar: Estimands
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
Discover your potential by working as a Covance Senior Principal / Principal Biostatistician. You'll enjoy a varied role working for different sponsors across several therapeutic areas, leading projects and mentoring junior members of the department.
Biometrics at AstraZeneca provides the data that influences decisions on how we roll back the frontiers of science to bring life-changing medicines to the world. We are at the heart of design, analytics and interpretation of AstraZeneca’s portfolio.