Presented by Rob Hemmings, Frank Petavy, Christine Fletcher, Frank Bretz
Rob Hemmings is a partner at Consilium Salmonson and Hemmings. He was formally the manager of the statisticians and pharmacokineticists at MHRA; a member of the EMA’s CHMP and chair of the EMA’s SAWP.
Frank Pétavy is Head of Biostatistics and Methodology Support at the European Medicines Agency. He contributes to the provision of scientific advice for drug development and the assessment of marketing authorisation applications across therapeutic areas.
Chrissie Fletcher is the Global Therapeutic Head of Biostatistics for Cardiovascular, Metabolic, Neuroscience, Bone, Inflammation and Nephrology, the European Regional Biostatistics Head and leads an HTA Biostatistics group at Amgen.
Frank Bretz is Global Head of the Statistical Methodology and Consulting group at Novartis. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs.
All of the speakers are members of the ICH Expert Working Group on this topic.
About the course:
Defining the primary objective of a clinical trial in a precise way to reflect the presence of non-compliance or non-adherence to treatment is crucial for the choice of design, the choice of statistical analysis and the interpretation of the results. This raises the need for a structured framework to specify the primary estimand (i.e. "what is to be estimated"). This is also reflected by the decision of the International Council on Harmonization (ICH) to amend its E9 guidance by discussing estimands and their role in clinical trials. The draft ICH E9 addendum on estimands and sensitivity analysis was released back in July 2017 and is being finalised while considering more than 1000 comments. All stakeholders are gaining the necessary experience and familiarity with estimands along with the associated challenges and methodologies. In this course we provide an in-depth review of the estimand framework as laid out by the draft ICH E9 addendum and present case studies illustrating the implementation of this framework in clinical trials.
The following topics will be covered:
Introduction and motivation for the ICH E9 addendum
- Understanding treatment effects
- Scope of the addendum to ICH E9
- Motivating examples
- Introduce a generic example to be a thread along the training course
A framework to align planning, design, conduct, analysis and interpretation
- A new framework for clinical trials
- Alignment between trial objective, design, planning, conduct, analysis and interpretation
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- How this framework can improve discussions between sponsors and regulators on the suitability of designs and the interpretation of results
Description, strategies and construction of estimands
- Attributes that together describe an estimand
- Strategies for addressing intercurrent events
- General considerations for the construction of estimands
- Therapeutic and experimental considerations for the construction of estimands
Generic example and case studies (Part 1)
- Generic example to illustrate the thinking process that aligns estimands and sensitivity analyses with trial objectives
- Case studies in specific disease settings: envisage a variety of options at the end of Day 1 and reconvene in the morning of Day 2 to select the preferred option(s)
Impact on trial design and conduct
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- Identification of estimand(s) at the design stage requires informed discussion with all stakeholders
- Certain estimands may require or benefit from non-standard designs and/or endpoints
Impact on trial analysis with focus on sensitivity analysis
- Role and choice of sensitivity analysis and supplementary analysis in light of the estimand framework
- Main estimation, sensitivity analysis, role and choice of sensitivity analysis, supplementary analysis
Documenting estimands and sensitivity analysis
- Impact of the addendum on protocol writing, study design, data analysis and interpretation
- Incorporating estimands in the writing of a trial protocol and statistical analysis plan
- Potential impact of the ICH E9 addendum on study conduct, data analysis and interpretation
Generic example and case studies (Part 2)
- Use examples to review the impact of using the estimand framework on study design and data collection; on the choice of estimation methods and sensitivity analysis
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1
09:00 – 16:30 on Day 2.
Registration
Early Bird (Up To & Including 24th April)
After 24th April
PSI Member
£495 + VAT
£595 + VAT
Non-Member
£570 + VAT (This includes PSI membership for 2019)
£670 + VAT (This includes PSI membership for 2019)
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 21st and 22nd May which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room. Rooms are charged at £109.00 inc VAT per room including breakfast.
Scientific Meetings
Estimands and Sensitivity Analysis in Clinical Trials
Crowne Plaza London Heathrow, Stockley Rd, West Drayton UB7 9NA
Presented by Rob Hemmings, Frank Petavy, Christine Fletcher, Frank Bretz
Rob Hemmings is a partner at Consilium Salmonson and Hemmings. He was formally the manager of the statisticians and pharmacokineticists at MHRA; a member of the EMA’s CHMP and chair of the EMA’s SAWP.
Frank Pétavy is Head of Biostatistics and Methodology Support at the European Medicines Agency. He contributes to the provision of scientific advice for drug development and the assessment of marketing authorisation applications across therapeutic areas.
Chrissie Fletcher is the Global Therapeutic Head of Biostatistics for Cardiovascular, Metabolic, Neuroscience, Bone, Inflammation and Nephrology, the European Regional Biostatistics Head and leads an HTA Biostatistics group at Amgen.
Frank Bretz is Global Head of the Statistical Methodology and Consulting group at Novartis. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs.
All of the speakers are members of the ICH Expert Working Group on this topic.
About the course:
Defining the primary objective of a clinical trial in a precise way to reflect the presence of non-compliance or non-adherence to treatment is crucial for the choice of design, the choice of statistical analysis and the interpretation of the results. This raises the need for a structured framework to specify the primary estimand (i.e. "what is to be estimated"). This is also reflected by the decision of the International Council on Harmonization (ICH) to amend its E9 guidance by discussing estimands and their role in clinical trials. The draft ICH E9 addendum on estimands and sensitivity analysis was released back in July 2017 and is being finalised while considering more than 1000 comments. All stakeholders are gaining the necessary experience and familiarity with estimands along with the associated challenges and methodologies. In this course we provide an in-depth review of the estimand framework as laid out by the draft ICH E9 addendum and present case studies illustrating the implementation of this framework in clinical trials.
The following topics will be covered:
Introduction and motivation for the ICH E9 addendum
- Understanding treatment effects
- Scope of the addendum to ICH E9
- Motivating examples
- Introduce a generic example to be a thread along the training course
A framework to align planning, design, conduct, analysis and interpretation
- A new framework for clinical trials
- Alignment between trial objective, design, planning, conduct, analysis and interpretation
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- How this framework can improve discussions between sponsors and regulators on the suitability of designs and the interpretation of results
Description, strategies and construction of estimands
- Attributes that together describe an estimand
- Strategies for addressing intercurrent events
- General considerations for the construction of estimands
- Therapeutic and experimental considerations for the construction of estimands
Generic example and case studies (Part 1)
- Generic example to illustrate the thinking process that aligns estimands and sensitivity analyses with trial objectives
- Case studies in specific disease settings: envisage a variety of options at the end of Day 1 and reconvene in the morning of Day 2 to select the preferred option(s)
Impact on trial design and conduct
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- Identification of estimand(s) at the design stage requires informed discussion with all stakeholders
- Certain estimands may require or benefit from non-standard designs and/or endpoints
Impact on trial analysis with focus on sensitivity analysis
- Role and choice of sensitivity analysis and supplementary analysis in light of the estimand framework
- Main estimation, sensitivity analysis, role and choice of sensitivity analysis, supplementary analysis
Documenting estimands and sensitivity analysis
- Impact of the addendum on protocol writing, study design, data analysis and interpretation
- Incorporating estimands in the writing of a trial protocol and statistical analysis plan
- Potential impact of the ICH E9 addendum on study conduct, data analysis and interpretation
Generic example and case studies (Part 2)
- Use examples to review the impact of using the estimand framework on study design and data collection; on the choice of estimation methods and sensitivity analysis
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1
09:00 – 16:30 on Day 2.
Registration
Early Bird (Up To & Including 24th April)
After 24th April
PSI Member
£495 + VAT
£595 + VAT
Non-Member
£570 + VAT (This includes PSI membership for 2019)
£670 + VAT (This includes PSI membership for 2019)
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 21st and 22nd May which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room. Rooms are charged at £109.00 inc VAT per room including breakfast.
Training Courses
Estimands and Sensitivity Analysis in Clinical Trials
Crowne Plaza London Heathrow, Stockley Rd, West Drayton UB7 9NA
Presented by Rob Hemmings, Frank Petavy, Christine Fletcher, Frank Bretz
Rob Hemmings is a partner at Consilium Salmonson and Hemmings. He was formally the manager of the statisticians and pharmacokineticists at MHRA; a member of the EMA’s CHMP and chair of the EMA’s SAWP.
Frank Pétavy is Head of Biostatistics and Methodology Support at the European Medicines Agency. He contributes to the provision of scientific advice for drug development and the assessment of marketing authorisation applications across therapeutic areas.
Chrissie Fletcher is the Global Therapeutic Head of Biostatistics for Cardiovascular, Metabolic, Neuroscience, Bone, Inflammation and Nephrology, the European Regional Biostatistics Head and leads an HTA Biostatistics group at Amgen.
Frank Bretz is Global Head of the Statistical Methodology and Consulting group at Novartis. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs.
All of the speakers are members of the ICH Expert Working Group on this topic.
About the course:
Defining the primary objective of a clinical trial in a precise way to reflect the presence of non-compliance or non-adherence to treatment is crucial for the choice of design, the choice of statistical analysis and the interpretation of the results. This raises the need for a structured framework to specify the primary estimand (i.e. "what is to be estimated"). This is also reflected by the decision of the International Council on Harmonization (ICH) to amend its E9 guidance by discussing estimands and their role in clinical trials. The draft ICH E9 addendum on estimands and sensitivity analysis was released back in July 2017 and is being finalised while considering more than 1000 comments. All stakeholders are gaining the necessary experience and familiarity with estimands along with the associated challenges and methodologies. In this course we provide an in-depth review of the estimand framework as laid out by the draft ICH E9 addendum and present case studies illustrating the implementation of this framework in clinical trials.
The following topics will be covered:
Introduction and motivation for the ICH E9 addendum
- Understanding treatment effects
- Scope of the addendum to ICH E9
- Motivating examples
- Introduce a generic example to be a thread along the training course
A framework to align planning, design, conduct, analysis and interpretation
- A new framework for clinical trials
- Alignment between trial objective, design, planning, conduct, analysis and interpretation
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- How this framework can improve discussions between sponsors and regulators on the suitability of designs and the interpretation of results
Description, strategies and construction of estimands
- Attributes that together describe an estimand
- Strategies for addressing intercurrent events
- General considerations for the construction of estimands
- Therapeutic and experimental considerations for the construction of estimands
Generic example and case studies (Part 1)
- Generic example to illustrate the thinking process that aligns estimands and sensitivity analyses with trial objectives
- Case studies in specific disease settings: envisage a variety of options at the end of Day 1 and reconvene in the morning of Day 2 to select the preferred option(s)
Impact on trial design and conduct
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- Identification of estimand(s) at the design stage requires informed discussion with all stakeholders
- Certain estimands may require or benefit from non-standard designs and/or endpoints
Impact on trial analysis with focus on sensitivity analysis
- Role and choice of sensitivity analysis and supplementary analysis in light of the estimand framework
- Main estimation, sensitivity analysis, role and choice of sensitivity analysis, supplementary analysis
Documenting estimands and sensitivity analysis
- Impact of the addendum on protocol writing, study design, data analysis and interpretation
- Incorporating estimands in the writing of a trial protocol and statistical analysis plan
- Potential impact of the ICH E9 addendum on study conduct, data analysis and interpretation
Generic example and case studies (Part 2)
- Use examples to review the impact of using the estimand framework on study design and data collection; on the choice of estimation methods and sensitivity analysis
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1
09:00 – 16:30 on Day 2.
Registration
Early Bird (Up To & Including 24th April)
After 24th April
PSI Member
£495 + VAT
£595 + VAT
Non-Member
£570 + VAT (This includes PSI membership for 2019)
£670 + VAT (This includes PSI membership for 2019)
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 21st and 22nd May which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room. Rooms are charged at £109.00 inc VAT per room including breakfast.
Journal Club
Estimands and Sensitivity Analysis in Clinical Trials
Crowne Plaza London Heathrow, Stockley Rd, West Drayton UB7 9NA
Presented by Rob Hemmings, Frank Petavy, Christine Fletcher, Frank Bretz
Rob Hemmings is a partner at Consilium Salmonson and Hemmings. He was formally the manager of the statisticians and pharmacokineticists at MHRA; a member of the EMA’s CHMP and chair of the EMA’s SAWP.
Frank Pétavy is Head of Biostatistics and Methodology Support at the European Medicines Agency. He contributes to the provision of scientific advice for drug development and the assessment of marketing authorisation applications across therapeutic areas.
Chrissie Fletcher is the Global Therapeutic Head of Biostatistics for Cardiovascular, Metabolic, Neuroscience, Bone, Inflammation and Nephrology, the European Regional Biostatistics Head and leads an HTA Biostatistics group at Amgen.
Frank Bretz is Global Head of the Statistical Methodology and Consulting group at Novartis. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs.
All of the speakers are members of the ICH Expert Working Group on this topic.
About the course:
Defining the primary objective of a clinical trial in a precise way to reflect the presence of non-compliance or non-adherence to treatment is crucial for the choice of design, the choice of statistical analysis and the interpretation of the results. This raises the need for a structured framework to specify the primary estimand (i.e. "what is to be estimated"). This is also reflected by the decision of the International Council on Harmonization (ICH) to amend its E9 guidance by discussing estimands and their role in clinical trials. The draft ICH E9 addendum on estimands and sensitivity analysis was released back in July 2017 and is being finalised while considering more than 1000 comments. All stakeholders are gaining the necessary experience and familiarity with estimands along with the associated challenges and methodologies. In this course we provide an in-depth review of the estimand framework as laid out by the draft ICH E9 addendum and present case studies illustrating the implementation of this framework in clinical trials.
The following topics will be covered:
Introduction and motivation for the ICH E9 addendum
- Understanding treatment effects
- Scope of the addendum to ICH E9
- Motivating examples
- Introduce a generic example to be a thread along the training course
A framework to align planning, design, conduct, analysis and interpretation
- A new framework for clinical trials
- Alignment between trial objective, design, planning, conduct, analysis and interpretation
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- How this framework can improve discussions between sponsors and regulators on the suitability of designs and the interpretation of results
Description, strategies and construction of estimands
- Attributes that together describe an estimand
- Strategies for addressing intercurrent events
- General considerations for the construction of estimands
- Therapeutic and experimental considerations for the construction of estimands
Generic example and case studies (Part 1)
- Generic example to illustrate the thinking process that aligns estimands and sensitivity analyses with trial objectives
- Case studies in specific disease settings: envisage a variety of options at the end of Day 1 and reconvene in the morning of Day 2 to select the preferred option(s)
Impact on trial design and conduct
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- Identification of estimand(s) at the design stage requires informed discussion with all stakeholders
- Certain estimands may require or benefit from non-standard designs and/or endpoints
Impact on trial analysis with focus on sensitivity analysis
- Role and choice of sensitivity analysis and supplementary analysis in light of the estimand framework
- Main estimation, sensitivity analysis, role and choice of sensitivity analysis, supplementary analysis
Documenting estimands and sensitivity analysis
- Impact of the addendum on protocol writing, study design, data analysis and interpretation
- Incorporating estimands in the writing of a trial protocol and statistical analysis plan
- Potential impact of the ICH E9 addendum on study conduct, data analysis and interpretation
Generic example and case studies (Part 2)
- Use examples to review the impact of using the estimand framework on study design and data collection; on the choice of estimation methods and sensitivity analysis
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1
09:00 – 16:30 on Day 2.
Registration
Early Bird (Up To & Including 24th April)
After 24th April
PSI Member
£495 + VAT
£595 + VAT
Non-Member
£570 + VAT (This includes PSI membership for 2019)
£670 + VAT (This includes PSI membership for 2019)
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 21st and 22nd May which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room. Rooms are charged at £109.00 inc VAT per room including breakfast.
Webinars
Estimands and Sensitivity Analysis in Clinical Trials
Crowne Plaza London Heathrow, Stockley Rd, West Drayton UB7 9NA
Presented by Rob Hemmings, Frank Petavy, Christine Fletcher, Frank Bretz
Rob Hemmings is a partner at Consilium Salmonson and Hemmings. He was formally the manager of the statisticians and pharmacokineticists at MHRA; a member of the EMA’s CHMP and chair of the EMA’s SAWP.
Frank Pétavy is Head of Biostatistics and Methodology Support at the European Medicines Agency. He contributes to the provision of scientific advice for drug development and the assessment of marketing authorisation applications across therapeutic areas.
Chrissie Fletcher is the Global Therapeutic Head of Biostatistics for Cardiovascular, Metabolic, Neuroscience, Bone, Inflammation and Nephrology, the European Regional Biostatistics Head and leads an HTA Biostatistics group at Amgen.
Frank Bretz is Global Head of the Statistical Methodology and Consulting group at Novartis. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs.
All of the speakers are members of the ICH Expert Working Group on this topic.
About the course:
Defining the primary objective of a clinical trial in a precise way to reflect the presence of non-compliance or non-adherence to treatment is crucial for the choice of design, the choice of statistical analysis and the interpretation of the results. This raises the need for a structured framework to specify the primary estimand (i.e. "what is to be estimated"). This is also reflected by the decision of the International Council on Harmonization (ICH) to amend its E9 guidance by discussing estimands and their role in clinical trials. The draft ICH E9 addendum on estimands and sensitivity analysis was released back in July 2017 and is being finalised while considering more than 1000 comments. All stakeholders are gaining the necessary experience and familiarity with estimands along with the associated challenges and methodologies. In this course we provide an in-depth review of the estimand framework as laid out by the draft ICH E9 addendum and present case studies illustrating the implementation of this framework in clinical trials.
The following topics will be covered:
Introduction and motivation for the ICH E9 addendum
- Understanding treatment effects
- Scope of the addendum to ICH E9
- Motivating examples
- Introduce a generic example to be a thread along the training course
A framework to align planning, design, conduct, analysis and interpretation
- A new framework for clinical trials
- Alignment between trial objective, design, planning, conduct, analysis and interpretation
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- How this framework can improve discussions between sponsors and regulators on the suitability of designs and the interpretation of results
Description, strategies and construction of estimands
- Attributes that together describe an estimand
- Strategies for addressing intercurrent events
- General considerations for the construction of estimands
- Therapeutic and experimental considerations for the construction of estimands
Generic example and case studies (Part 1)
- Generic example to illustrate the thinking process that aligns estimands and sensitivity analyses with trial objectives
- Case studies in specific disease settings: envisage a variety of options at the end of Day 1 and reconvene in the morning of Day 2 to select the preferred option(s)
Impact on trial design and conduct
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- Identification of estimand(s) at the design stage requires informed discussion with all stakeholders
- Certain estimands may require or benefit from non-standard designs and/or endpoints
Impact on trial analysis with focus on sensitivity analysis
- Role and choice of sensitivity analysis and supplementary analysis in light of the estimand framework
- Main estimation, sensitivity analysis, role and choice of sensitivity analysis, supplementary analysis
Documenting estimands and sensitivity analysis
- Impact of the addendum on protocol writing, study design, data analysis and interpretation
- Incorporating estimands in the writing of a trial protocol and statistical analysis plan
- Potential impact of the ICH E9 addendum on study conduct, data analysis and interpretation
Generic example and case studies (Part 2)
- Use examples to review the impact of using the estimand framework on study design and data collection; on the choice of estimation methods and sensitivity analysis
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1
09:00 – 16:30 on Day 2.
Registration
Early Bird (Up To & Including 24th April)
After 24th April
PSI Member
£495 + VAT
£595 + VAT
Non-Member
£570 + VAT (This includes PSI membership for 2019)
£670 + VAT (This includes PSI membership for 2019)
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 21st and 22nd May which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room. Rooms are charged at £109.00 inc VAT per room including breakfast.
Careers Meetings
Estimands and Sensitivity Analysis in Clinical Trials
Crowne Plaza London Heathrow, Stockley Rd, West Drayton UB7 9NA
Presented by Rob Hemmings, Frank Petavy, Christine Fletcher, Frank Bretz
Rob Hemmings is a partner at Consilium Salmonson and Hemmings. He was formally the manager of the statisticians and pharmacokineticists at MHRA; a member of the EMA’s CHMP and chair of the EMA’s SAWP.
Frank Pétavy is Head of Biostatistics and Methodology Support at the European Medicines Agency. He contributes to the provision of scientific advice for drug development and the assessment of marketing authorisation applications across therapeutic areas.
Chrissie Fletcher is the Global Therapeutic Head of Biostatistics for Cardiovascular, Metabolic, Neuroscience, Bone, Inflammation and Nephrology, the European Regional Biostatistics Head and leads an HTA Biostatistics group at Amgen.
Frank Bretz is Global Head of the Statistical Methodology and Consulting group at Novartis. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs.
All of the speakers are members of the ICH Expert Working Group on this topic.
About the course:
Defining the primary objective of a clinical trial in a precise way to reflect the presence of non-compliance or non-adherence to treatment is crucial for the choice of design, the choice of statistical analysis and the interpretation of the results. This raises the need for a structured framework to specify the primary estimand (i.e. "what is to be estimated"). This is also reflected by the decision of the International Council on Harmonization (ICH) to amend its E9 guidance by discussing estimands and their role in clinical trials. The draft ICH E9 addendum on estimands and sensitivity analysis was released back in July 2017 and is being finalised while considering more than 1000 comments. All stakeholders are gaining the necessary experience and familiarity with estimands along with the associated challenges and methodologies. In this course we provide an in-depth review of the estimand framework as laid out by the draft ICH E9 addendum and present case studies illustrating the implementation of this framework in clinical trials.
The following topics will be covered:
Introduction and motivation for the ICH E9 addendum
- Understanding treatment effects
- Scope of the addendum to ICH E9
- Motivating examples
- Introduce a generic example to be a thread along the training course
A framework to align planning, design, conduct, analysis and interpretation
- A new framework for clinical trials
- Alignment between trial objective, design, planning, conduct, analysis and interpretation
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- How this framework can improve discussions between sponsors and regulators on the suitability of designs and the interpretation of results
Description, strategies and construction of estimands
- Attributes that together describe an estimand
- Strategies for addressing intercurrent events
- General considerations for the construction of estimands
- Therapeutic and experimental considerations for the construction of estimands
Generic example and case studies (Part 1)
- Generic example to illustrate the thinking process that aligns estimands and sensitivity analyses with trial objectives
- Case studies in specific disease settings: envisage a variety of options at the end of Day 1 and reconvene in the morning of Day 2 to select the preferred option(s)
Impact on trial design and conduct
- Implications on design and conduct of clinical trials and in the performance of statistical analyses
- Identification of estimand(s) at the design stage requires informed discussion with all stakeholders
- Certain estimands may require or benefit from non-standard designs and/or endpoints
Impact on trial analysis with focus on sensitivity analysis
- Role and choice of sensitivity analysis and supplementary analysis in light of the estimand framework
- Main estimation, sensitivity analysis, role and choice of sensitivity analysis, supplementary analysis
Documenting estimands and sensitivity analysis
- Impact of the addendum on protocol writing, study design, data analysis and interpretation
- Incorporating estimands in the writing of a trial protocol and statistical analysis plan
- Potential impact of the ICH E9 addendum on study conduct, data analysis and interpretation
Generic example and case studies (Part 2)
- Use examples to review the impact of using the estimand framework on study design and data collection; on the choice of estimation methods and sensitivity analysis
Course runs from: 10:00 – 17:30 (registration from 9:30) on Day 1
09:00 – 16:30 on Day 2.
Registration
Early Bird (Up To & Including 24th April)
After 24th April
PSI Member
£495 + VAT
£595 + VAT
Non-Member
£570 + VAT (This includes PSI membership for 2019)
£670 + VAT (This includes PSI membership for 2019)
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 21st and 22nd May which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room. Rooms are charged at £109.00 inc VAT per room including breakfast.
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.
PSI Book Club - The Art of Explanation: How to Communicate with Clarity and Confidence
Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.
Our monthly webinar will allow attendees to gain practical knowledge and skills in Open-Source coding and tools, with a focus on applications in the pharmaceutical industry. The sessions will provide starting points in a number of areas, correct any common misconceptions and provide valuable resources for further learning.
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Pre-Clinical SIG Webinar: AI agents for drug discovery and development
AI agents are large language models equipped with tools that can autonomously tackle challenging tasks. This talk will explore how generative AI agents can enable biomedical discovery.
EFSPI/PSI Causal Inference SIG Webinar: Instrumental Variable Methods
The webinar is targeted at statisticians working in the pharmaceutical industry, and the objective is to 1) provide a basic understanding of IV methodology including how it relates to causal inference, and 2) present two inspirational pharma-relevant applications.
The Pre-Clinical Special Interest Group (SIG) Workshop 2025 will take place over two half-days on 7 - 8 October in Verona, Italy, bringing together experts from industry, academia, and regulatory institutions to discuss key challenges and innovations in pre-clinical research.
PSI Training Course: Introduction to Machine Learning
Four sessions will include ML foundation (including an introduction, data exploration for ML and dimensionality reduction and feature selection), Supervised learning (including support vector machines and model evaluation and interpretation), model optimization and unsupervised learning (including clustering) and advanced topics (including neural networks, deep learning and large language models).
The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.
Date: 19 November 2025
This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Associate Director Biostatistics in Early Development - Novartis
As an Associate Director Biostatistics Early Development, you will be a key member of our biostatistics group, you will play a crucial role in the design, analysis, and interpretation of clinical trials for early development programs.
Associate Director Biostatistics, Real World Data - Novartis
If you are passionate about biostatistics and real-world data, and are looking for an exciting opportunity to contribute to groundbreaking research, we encourage you to apply.
Are you passionate about making a difference in the world of healthcare? Novartis is seeking a dynamic and experienced professional to join our team in London at The Westworks.
Director of HTA Biostatistics & Medical Affairs - Novartis
As the Director of HTA Biostatistics & Medical Affairs, you will play a pivotal role in shaping the future of healthcare by providing strategic biostatistical leadership and expertise.
Senior Medical Statistician & Statistical Programmer
An exciting opportunity has arisen for a permanent Senior Medical Statistician & Statistical Programmer to join the UKCRC fully registered Derby Clinical Trials Support Unit (Derby CTSU).
As a Senior Principal Biostatistician, you will be responsible and accountable for all statistical work, both scientific and operational, for one or more assigned clinical trials
We use cookies to collect and analyse information on site performance and usage, to provide social media features and to enhance and customise content and advertisements.
Cookies used on the site are categorized and below you can read about each category and allow or deny some or all of them. When categories than have been previously allowed are disabled, all cookies assigned to that category will be removed from your browser.
Additionally you can see a list of cookies assigned to each category and detailed information in the cookie declaration.
Some cookies are required to provide core functionality. The website won't function properly without these cookies and they are enabled by default and cannot be disabled.
AWS Elastic Load Balancing (ELB) automatically distributes incoming web traffic across multiple servers or services hosted on AWS.
AWSALBTGCORS
AWSALBCORS
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.
Vimeo, Inc. is an American video hosting, sharing, services provider, and broadcaster. Vimeo focuses on the delivery of high-definition video across a range of devices.
Cookies used on the site are categorized and below you can read about each category and allow or deny some or all of them. When categories than have been previously allowed are disabled, all cookies assigned to that category will be removed from your browser.
Additionally you can see a list of cookies assigned to each category and detailed information in the cookie declaration.
Some cookies are required to provide core functionality. The website won't function properly without these cookies and they are enabled by default and cannot be disabled.
Necessary cookies
Name
Hostname
Vendor
Expiry
ARRAffinity
.psiweb.org
Session
This cookie is set by websites run on the Windows Azure cloud platform. It is used for load balancing to make sure the visitor page requests are routed to the same server in any browsing session.
ARRAffinitySameSite
.psiweb.org
Session
Used to distribute traffic to the website on several servers in order to optimize response times.
__cf_bm
.vimeo.com
Cloudflare, Inc.
1 hour
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption.
_cfuvid
.vimeo.com
Cloudflare, Inc.
Session
Used by Cloudflare WAF to distinguish individual users who share the same IP address and apply rate limits
__cf_bm
.glueup.com
Cloudflare, Inc.
1 hour
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption.
AWSALBTGCORS
psi.glueup.com
Amazon Web Services, Inc.
7 days
Used by Target Group-based load balancers for session stickiness.
AWSALBCORS
psi.glueup.com
Amazon Web Services, Inc.
7 days
Maintains session stickiness and secure routing between the user and backend servers through AWS load balancing.
PHPSESSID
psi.glueup.com
Session
Cookie generated by applications based on the PHP language. This is a general purpose identifier used to maintain user session variables. It is normally a random generated number, how it is used can be specific to the site, but a good example is maintaining a logged-in status for a user between pages.
Used by CookieHub to store information about whether visitors have given or declined the use of cookie categories used on the site.
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
Preferences
Name
Hostname
Vendor
Expiry
vuid
.vimeo.com
400 days
These cookies are used by the Vimeo video player on websites.
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.