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
PSI Mentoring 2025
Date: Ongoing 6 month cycle beginning late April/early May 2024
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 Training Course: Mixed Models and Repeated Measures
This course is presented through lectures and practical sessions using SAS code. It is suitable for statisticians working on clinical trials, who already have a good understanding of linear and generalised linear models.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This is an interactive online training workshop providing an in-depth review of the estimand framework as laid out by ICH E9(R1) addendum with inputs from estimand experts, case studies, quizzes and opportunity for discussions. You will develop an estimand in a therapeutic area of interest to your company. In an online break-out room, you will join a series of team discussions to implement the estimand framework in a case study, aligning estimands, design, conduct, analysis, (assumptions + sensitivity analyses) to the clinical objective and therapeutic setting.
Maths Meets Medicine: Exploring Careers in the Pharmaceutical Industry
This session will showcase how careers in pharmaceutical statistics can be both rewarding and impactful, with a focus on how mathematics is integral to the development of medicines. Students will hear from industry experts, explore diverse career paths, and learn why continuing to study math is key to unlocking exciting opportunities in the healthcare sector.
Dissolution Testing: Time for Statistical (r)Evolution
Webinar dedicated to the topic of dissolution of oral solid dosage forms; opportunity to hear from statisticians working in the CMC field, with open question and answers.
In addition, the CMC Statistical Network Europe special interest group will discuss advocacy opportunities, have your say to contribute to the future direction.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
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