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.
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.
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.
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.
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.
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.
Topic: R Package Basics.
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.
Date: Ongoing 6 month cycle beginning late April/early May 2026
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event!
Haven’t read the book yet? Pick up a copy today and join us.
Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.