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.
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.
