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
- Power
Sample Sizes for Different Clinical Trial Objectives - Superiority
- Equivalence
- Non-inferiority
- Precision based
- Bioequivalence
- Pilot studies
Sample Sizes for Different Types of Data - Normal
- Binary
- Ordinal
- Survival
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
PSI Members
£495 + VAT
Non-Members
£570 + VAT (includes PSI membership for 1 year)
After 30th May 2017
PSI Members
£595 + VAT
Non-Members
£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.
Upcoming Events
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Introduction to Industry Training (ITIT) Course - 2024/2025
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK