Dates: Session 1 - Tuesday 20th October 2026 Session 2 - Wednesday 21st October 2026 Time: 13:00 - 16:00 BST | 14:00 - 17:00 CET | 08:00 - 11:00 EET Location: Online via Zoom
Who is this event intended for?
Fully open. Statisticians in clinical research, all stages of career
What is the benefit of attending?
Gain a practical understanding of adaptive clinical trial designs and the principles of ICH E20, enabling you to make more informed contributions to the planning, conduct, and evaluation of adaptive clinical studies within modern drug development.
Overview
This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.
Abstract
Adaptive clinical trials have moved from being viewed as specialized methodological innovations to becoming an increasingly important component of modern drug development. When appropriately planned, conducted, and interpreted, adaptive designs can improve the efficiency of clinical drug development, make better use of accumulating information, and support more informed decision-making. At the same time, they raise important statistical, operational, and regulatory considerations, particularly in confirmatory settings where control of error rates, trial integrity, and interpretability remain paramount. This virtual course, delivered over two afternoons, provides a structured introduction to adaptive clinical trials for participants seeking a scientifically grounded and practice-oriented overview of the field. Rather than focusing on technical derivations, the course will emphasize conceptual understanding, practical design considerations, and learning through examples.
A central component of the course will be an introduction to ICH E20 and its implications for the design, conduct, analysis, and interpretation of adaptive clinical trials. The course will explain the underlying rationale of the guideline and discuss how it frames adaptive design principles within a broader regulatory and scientific context. Particular attention will be given to principles such as adequacy within the development program, adequacy of trial planning, limiting the chances of erroneous conclusions, reliability of estimation, and maintenance of trial integrity. The aim is not to summarize the main themes of the guidance, but how to place adaptive designs into the wider landscape of a clinical development strategy and cross-functional decision-making.
The course will discuss common types of adaptations, with a focus on specific considerations relevant to the principles. The methodological component is intentionally selective and accessible rather than exhaustive. It will cover early, among others, trial stopping, sample size adaptations, population selection, and treatment selection. Applications and case studies will form an important part of the training. Realistic examples will be used to illustrate when adaptive approaches can add value, when they may be less useful, and how design choices should be aligned with the scientific question, the stage of development, and the practical realities of trial conduct. These examples will also show how adaptive designs are evaluated by different stakeholders, including statisticians, clinicians, regulators, and development teams.
Finally, the course will address the broader strategic value of adaptive designs in drug development. Adaptive methods should not be viewed merely as technical tools, but as part of a broader framework for managing uncertainty, improving development efficiency, and aligning evidence generation with decision-making needs. Participants will come away with a clearer understanding of the opportunities, limitations, and implementation requirements of adaptive clinical trials, as well as a more informed perspective on when their use is scientifically and strategically justified.
Cost
Early Bird PSI Members: £180 +VAT PSI Members: £210 +VAT
Early Bird Non-PSI Members: £290 +VAT Non-PSI Members: £320 +VAT *Please note: Non-Member rates include PSI membership until 31 Dec. 2027.
Registration
Early Bird registration closes on Friday 28th August. To register for this event, please click here.
Speaker details
Speaker
Biography
Frank Bretz, Novartis
Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has contributed to methodological advancements in several areas of drug development, including adaptive designs, dose finding, estimands, and multiple testing. He was a member of the ICH E9(R1) Expert Working Group on “Estimands and sensitivity analysis in clinical trials”, a subject matter expert for the ICH M11 Expert Working Group on “Clinical electronic structured harmonised protocol”, and currently serves on the ICH E20 Expert Working Group on “Adaptive designs for clinical trials”.
Hans Ulrich Burger, Hoffmann- La Roche
Hans Ulrich Burger worked for more than 30 years at Hoffmann- La Roche in Basel as a statistician in various positions and therapeutic areas. He has experience in early and late drug development and contributed to a lot of clinical trials including trials with an adaptive design. He was involved from the beginning in the organization of the EFSPI regulatory statistics workshop and many other seminars and conferences. He currently serves on the ICH E20 Expert Working Group on adaptive designs in clinical trials, and is one of the three editors in chief of the Biometrical Journal.
Dates: Session 1 - Tuesday 20th October 2026 Session 2 - Wednesday 21st October 2026 Time: 13:00 - 16:00 BST | 14:00 - 17:00 CET | 08:00 - 11:00 EET Location: Online via Zoom
Who is this event intended for?
Fully open. Statisticians in clinical research, all stages of career
What is the benefit of attending?
Gain a practical understanding of adaptive clinical trial designs and the principles of ICH E20, enabling you to make more informed contributions to the planning, conduct, and evaluation of adaptive clinical studies within modern drug development.
Overview
This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.
Abstract
Adaptive clinical trials have moved from being viewed as specialized methodological innovations to becoming an increasingly important component of modern drug development. When appropriately planned, conducted, and interpreted, adaptive designs can improve the efficiency of clinical drug development, make better use of accumulating information, and support more informed decision-making. At the same time, they raise important statistical, operational, and regulatory considerations, particularly in confirmatory settings where control of error rates, trial integrity, and interpretability remain paramount. This virtual course, delivered over two afternoons, provides a structured introduction to adaptive clinical trials for participants seeking a scientifically grounded and practice-oriented overview of the field. Rather than focusing on technical derivations, the course will emphasize conceptual understanding, practical design considerations, and learning through examples.
A central component of the course will be an introduction to ICH E20 and its implications for the design, conduct, analysis, and interpretation of adaptive clinical trials. The course will explain the underlying rationale of the guideline and discuss how it frames adaptive design principles within a broader regulatory and scientific context. Particular attention will be given to principles such as adequacy within the development program, adequacy of trial planning, limiting the chances of erroneous conclusions, reliability of estimation, and maintenance of trial integrity. The aim is not to summarize the main themes of the guidance, but how to place adaptive designs into the wider landscape of a clinical development strategy and cross-functional decision-making.
The course will discuss common types of adaptations, with a focus on specific considerations relevant to the principles. The methodological component is intentionally selective and accessible rather than exhaustive. It will cover early, among others, trial stopping, sample size adaptations, population selection, and treatment selection. Applications and case studies will form an important part of the training. Realistic examples will be used to illustrate when adaptive approaches can add value, when they may be less useful, and how design choices should be aligned with the scientific question, the stage of development, and the practical realities of trial conduct. These examples will also show how adaptive designs are evaluated by different stakeholders, including statisticians, clinicians, regulators, and development teams.
Finally, the course will address the broader strategic value of adaptive designs in drug development. Adaptive methods should not be viewed merely as technical tools, but as part of a broader framework for managing uncertainty, improving development efficiency, and aligning evidence generation with decision-making needs. Participants will come away with a clearer understanding of the opportunities, limitations, and implementation requirements of adaptive clinical trials, as well as a more informed perspective on when their use is scientifically and strategically justified.
Cost
Early Bird PSI Members: £180 +VAT PSI Members: £210 +VAT
Early Bird Non-PSI Members: £290 +VAT Non-PSI Members: £320 +VAT *Please note: Non-Member rates include PSI membership until 31 Dec. 2027.
Registration
Early Bird registration closes on Friday 28th August. To register for this event, please click here.
Speaker details
Speaker
Biography
Frank Bretz, Novartis
Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has contributed to methodological advancements in several areas of drug development, including adaptive designs, dose finding, estimands, and multiple testing. He was a member of the ICH E9(R1) Expert Working Group on “Estimands and sensitivity analysis in clinical trials”, a subject matter expert for the ICH M11 Expert Working Group on “Clinical electronic structured harmonised protocol”, and currently serves on the ICH E20 Expert Working Group on “Adaptive designs for clinical trials”.
Hans Ulrich Burger, Hoffmann- La Roche
Hans Ulrich Burger worked for more than 30 years at Hoffmann- La Roche in Basel as a statistician in various positions and therapeutic areas. He has experience in early and late drug development and contributed to a lot of clinical trials including trials with an adaptive design. He was involved from the beginning in the organization of the EFSPI regulatory statistics workshop and many other seminars and conferences. He currently serves on the ICH E20 Expert Working Group on adaptive designs in clinical trials, and is one of the three editors in chief of the Biometrical Journal.
Dates: Session 1 - Tuesday 20th October 2026 Session 2 - Wednesday 21st October 2026 Time: 13:00 - 16:00 BST | 14:00 - 17:00 CET | 08:00 - 11:00 EET Location: Online via Zoom
Who is this event intended for?
Fully open. Statisticians in clinical research, all stages of career
What is the benefit of attending?
Gain a practical understanding of adaptive clinical trial designs and the principles of ICH E20, enabling you to make more informed contributions to the planning, conduct, and evaluation of adaptive clinical studies within modern drug development.
Overview
This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.
Abstract
Adaptive clinical trials have moved from being viewed as specialized methodological innovations to becoming an increasingly important component of modern drug development. When appropriately planned, conducted, and interpreted, adaptive designs can improve the efficiency of clinical drug development, make better use of accumulating information, and support more informed decision-making. At the same time, they raise important statistical, operational, and regulatory considerations, particularly in confirmatory settings where control of error rates, trial integrity, and interpretability remain paramount. This virtual course, delivered over two afternoons, provides a structured introduction to adaptive clinical trials for participants seeking a scientifically grounded and practice-oriented overview of the field. Rather than focusing on technical derivations, the course will emphasize conceptual understanding, practical design considerations, and learning through examples.
A central component of the course will be an introduction to ICH E20 and its implications for the design, conduct, analysis, and interpretation of adaptive clinical trials. The course will explain the underlying rationale of the guideline and discuss how it frames adaptive design principles within a broader regulatory and scientific context. Particular attention will be given to principles such as adequacy within the development program, adequacy of trial planning, limiting the chances of erroneous conclusions, reliability of estimation, and maintenance of trial integrity. The aim is not to summarize the main themes of the guidance, but how to place adaptive designs into the wider landscape of a clinical development strategy and cross-functional decision-making.
The course will discuss common types of adaptations, with a focus on specific considerations relevant to the principles. The methodological component is intentionally selective and accessible rather than exhaustive. It will cover early, among others, trial stopping, sample size adaptations, population selection, and treatment selection. Applications and case studies will form an important part of the training. Realistic examples will be used to illustrate when adaptive approaches can add value, when they may be less useful, and how design choices should be aligned with the scientific question, the stage of development, and the practical realities of trial conduct. These examples will also show how adaptive designs are evaluated by different stakeholders, including statisticians, clinicians, regulators, and development teams.
Finally, the course will address the broader strategic value of adaptive designs in drug development. Adaptive methods should not be viewed merely as technical tools, but as part of a broader framework for managing uncertainty, improving development efficiency, and aligning evidence generation with decision-making needs. Participants will come away with a clearer understanding of the opportunities, limitations, and implementation requirements of adaptive clinical trials, as well as a more informed perspective on when their use is scientifically and strategically justified.
Cost
Early Bird PSI Members: £180 +VAT PSI Members: £210 +VAT
Early Bird Non-PSI Members: £290 +VAT Non-PSI Members: £320 +VAT *Please note: Non-Member rates include PSI membership until 31 Dec. 2027.
Registration
Early Bird registration closes on Friday 28th August. To register for this event, please click here.
Speaker details
Speaker
Biography
Frank Bretz, Novartis
Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has contributed to methodological advancements in several areas of drug development, including adaptive designs, dose finding, estimands, and multiple testing. He was a member of the ICH E9(R1) Expert Working Group on “Estimands and sensitivity analysis in clinical trials”, a subject matter expert for the ICH M11 Expert Working Group on “Clinical electronic structured harmonised protocol”, and currently serves on the ICH E20 Expert Working Group on “Adaptive designs for clinical trials”.
Hans Ulrich Burger, Hoffmann- La Roche
Hans Ulrich Burger worked for more than 30 years at Hoffmann- La Roche in Basel as a statistician in various positions and therapeutic areas. He has experience in early and late drug development and contributed to a lot of clinical trials including trials with an adaptive design. He was involved from the beginning in the organization of the EFSPI regulatory statistics workshop and many other seminars and conferences. He currently serves on the ICH E20 Expert Working Group on adaptive designs in clinical trials, and is one of the three editors in chief of the Biometrical Journal.
Dates: Session 1 - Tuesday 20th October 2026 Session 2 - Wednesday 21st October 2026 Time: 13:00 - 16:00 BST | 14:00 - 17:00 CET | 08:00 - 11:00 EET Location: Online via Zoom
Who is this event intended for?
Fully open. Statisticians in clinical research, all stages of career
What is the benefit of attending?
Gain a practical understanding of adaptive clinical trial designs and the principles of ICH E20, enabling you to make more informed contributions to the planning, conduct, and evaluation of adaptive clinical studies within modern drug development.
Overview
This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.
Abstract
Adaptive clinical trials have moved from being viewed as specialized methodological innovations to becoming an increasingly important component of modern drug development. When appropriately planned, conducted, and interpreted, adaptive designs can improve the efficiency of clinical drug development, make better use of accumulating information, and support more informed decision-making. At the same time, they raise important statistical, operational, and regulatory considerations, particularly in confirmatory settings where control of error rates, trial integrity, and interpretability remain paramount. This virtual course, delivered over two afternoons, provides a structured introduction to adaptive clinical trials for participants seeking a scientifically grounded and practice-oriented overview of the field. Rather than focusing on technical derivations, the course will emphasize conceptual understanding, practical design considerations, and learning through examples.
A central component of the course will be an introduction to ICH E20 and its implications for the design, conduct, analysis, and interpretation of adaptive clinical trials. The course will explain the underlying rationale of the guideline and discuss how it frames adaptive design principles within a broader regulatory and scientific context. Particular attention will be given to principles such as adequacy within the development program, adequacy of trial planning, limiting the chances of erroneous conclusions, reliability of estimation, and maintenance of trial integrity. The aim is not to summarize the main themes of the guidance, but how to place adaptive designs into the wider landscape of a clinical development strategy and cross-functional decision-making.
The course will discuss common types of adaptations, with a focus on specific considerations relevant to the principles. The methodological component is intentionally selective and accessible rather than exhaustive. It will cover early, among others, trial stopping, sample size adaptations, population selection, and treatment selection. Applications and case studies will form an important part of the training. Realistic examples will be used to illustrate when adaptive approaches can add value, when they may be less useful, and how design choices should be aligned with the scientific question, the stage of development, and the practical realities of trial conduct. These examples will also show how adaptive designs are evaluated by different stakeholders, including statisticians, clinicians, regulators, and development teams.
Finally, the course will address the broader strategic value of adaptive designs in drug development. Adaptive methods should not be viewed merely as technical tools, but as part of a broader framework for managing uncertainty, improving development efficiency, and aligning evidence generation with decision-making needs. Participants will come away with a clearer understanding of the opportunities, limitations, and implementation requirements of adaptive clinical trials, as well as a more informed perspective on when their use is scientifically and strategically justified.
Cost
Early Bird PSI Members: £180 +VAT PSI Members: £210 +VAT
Early Bird Non-PSI Members: £290 +VAT Non-PSI Members: £320 +VAT *Please note: Non-Member rates include PSI membership until 31 Dec. 2027.
Registration
Early Bird registration closes on Friday 28th August. To register for this event, please click here.
Speaker details
Speaker
Biography
Frank Bretz, Novartis
Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has contributed to methodological advancements in several areas of drug development, including adaptive designs, dose finding, estimands, and multiple testing. He was a member of the ICH E9(R1) Expert Working Group on “Estimands and sensitivity analysis in clinical trials”, a subject matter expert for the ICH M11 Expert Working Group on “Clinical electronic structured harmonised protocol”, and currently serves on the ICH E20 Expert Working Group on “Adaptive designs for clinical trials”.
Hans Ulrich Burger, Hoffmann- La Roche
Hans Ulrich Burger worked for more than 30 years at Hoffmann- La Roche in Basel as a statistician in various positions and therapeutic areas. He has experience in early and late drug development and contributed to a lot of clinical trials including trials with an adaptive design. He was involved from the beginning in the organization of the EFSPI regulatory statistics workshop and many other seminars and conferences. He currently serves on the ICH E20 Expert Working Group on adaptive designs in clinical trials, and is one of the three editors in chief of the Biometrical Journal.
Dates: Session 1 - Tuesday 20th October 2026 Session 2 - Wednesday 21st October 2026 Time: 13:00 - 16:00 BST | 14:00 - 17:00 CET | 08:00 - 11:00 EET Location: Online via Zoom
Who is this event intended for?
Fully open. Statisticians in clinical research, all stages of career
What is the benefit of attending?
Gain a practical understanding of adaptive clinical trial designs and the principles of ICH E20, enabling you to make more informed contributions to the planning, conduct, and evaluation of adaptive clinical studies within modern drug development.
Overview
This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.
Abstract
Adaptive clinical trials have moved from being viewed as specialized methodological innovations to becoming an increasingly important component of modern drug development. When appropriately planned, conducted, and interpreted, adaptive designs can improve the efficiency of clinical drug development, make better use of accumulating information, and support more informed decision-making. At the same time, they raise important statistical, operational, and regulatory considerations, particularly in confirmatory settings where control of error rates, trial integrity, and interpretability remain paramount. This virtual course, delivered over two afternoons, provides a structured introduction to adaptive clinical trials for participants seeking a scientifically grounded and practice-oriented overview of the field. Rather than focusing on technical derivations, the course will emphasize conceptual understanding, practical design considerations, and learning through examples.
A central component of the course will be an introduction to ICH E20 and its implications for the design, conduct, analysis, and interpretation of adaptive clinical trials. The course will explain the underlying rationale of the guideline and discuss how it frames adaptive design principles within a broader regulatory and scientific context. Particular attention will be given to principles such as adequacy within the development program, adequacy of trial planning, limiting the chances of erroneous conclusions, reliability of estimation, and maintenance of trial integrity. The aim is not to summarize the main themes of the guidance, but how to place adaptive designs into the wider landscape of a clinical development strategy and cross-functional decision-making.
The course will discuss common types of adaptations, with a focus on specific considerations relevant to the principles. The methodological component is intentionally selective and accessible rather than exhaustive. It will cover early, among others, trial stopping, sample size adaptations, population selection, and treatment selection. Applications and case studies will form an important part of the training. Realistic examples will be used to illustrate when adaptive approaches can add value, when they may be less useful, and how design choices should be aligned with the scientific question, the stage of development, and the practical realities of trial conduct. These examples will also show how adaptive designs are evaluated by different stakeholders, including statisticians, clinicians, regulators, and development teams.
Finally, the course will address the broader strategic value of adaptive designs in drug development. Adaptive methods should not be viewed merely as technical tools, but as part of a broader framework for managing uncertainty, improving development efficiency, and aligning evidence generation with decision-making needs. Participants will come away with a clearer understanding of the opportunities, limitations, and implementation requirements of adaptive clinical trials, as well as a more informed perspective on when their use is scientifically and strategically justified.
Cost
Early Bird PSI Members: £180 +VAT PSI Members: £210 +VAT
Early Bird Non-PSI Members: £290 +VAT Non-PSI Members: £320 +VAT *Please note: Non-Member rates include PSI membership until 31 Dec. 2027.
Registration
Early Bird registration closes on Friday 28th August. To register for this event, please click here.
Speaker details
Speaker
Biography
Frank Bretz, Novartis
Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has contributed to methodological advancements in several areas of drug development, including adaptive designs, dose finding, estimands, and multiple testing. He was a member of the ICH E9(R1) Expert Working Group on “Estimands and sensitivity analysis in clinical trials”, a subject matter expert for the ICH M11 Expert Working Group on “Clinical electronic structured harmonised protocol”, and currently serves on the ICH E20 Expert Working Group on “Adaptive designs for clinical trials”.
Hans Ulrich Burger, Hoffmann- La Roche
Hans Ulrich Burger worked for more than 30 years at Hoffmann- La Roche in Basel as a statistician in various positions and therapeutic areas. He has experience in early and late drug development and contributed to a lot of clinical trials including trials with an adaptive design. He was involved from the beginning in the organization of the EFSPI regulatory statistics workshop and many other seminars and conferences. He currently serves on the ICH E20 Expert Working Group on adaptive designs in clinical trials, and is one of the three editors in chief of the Biometrical Journal.
Dates: Session 1 - Tuesday 20th October 2026 Session 2 - Wednesday 21st October 2026 Time: 13:00 - 16:00 BST | 14:00 - 17:00 CET | 08:00 - 11:00 EET Location: Online via Zoom
Who is this event intended for?
Fully open. Statisticians in clinical research, all stages of career
What is the benefit of attending?
Gain a practical understanding of adaptive clinical trial designs and the principles of ICH E20, enabling you to make more informed contributions to the planning, conduct, and evaluation of adaptive clinical studies within modern drug development.
Overview
This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.
Abstract
Adaptive clinical trials have moved from being viewed as specialized methodological innovations to becoming an increasingly important component of modern drug development. When appropriately planned, conducted, and interpreted, adaptive designs can improve the efficiency of clinical drug development, make better use of accumulating information, and support more informed decision-making. At the same time, they raise important statistical, operational, and regulatory considerations, particularly in confirmatory settings where control of error rates, trial integrity, and interpretability remain paramount. This virtual course, delivered over two afternoons, provides a structured introduction to adaptive clinical trials for participants seeking a scientifically grounded and practice-oriented overview of the field. Rather than focusing on technical derivations, the course will emphasize conceptual understanding, practical design considerations, and learning through examples.
A central component of the course will be an introduction to ICH E20 and its implications for the design, conduct, analysis, and interpretation of adaptive clinical trials. The course will explain the underlying rationale of the guideline and discuss how it frames adaptive design principles within a broader regulatory and scientific context. Particular attention will be given to principles such as adequacy within the development program, adequacy of trial planning, limiting the chances of erroneous conclusions, reliability of estimation, and maintenance of trial integrity. The aim is not to summarize the main themes of the guidance, but how to place adaptive designs into the wider landscape of a clinical development strategy and cross-functional decision-making.
The course will discuss common types of adaptations, with a focus on specific considerations relevant to the principles. The methodological component is intentionally selective and accessible rather than exhaustive. It will cover early, among others, trial stopping, sample size adaptations, population selection, and treatment selection. Applications and case studies will form an important part of the training. Realistic examples will be used to illustrate when adaptive approaches can add value, when they may be less useful, and how design choices should be aligned with the scientific question, the stage of development, and the practical realities of trial conduct. These examples will also show how adaptive designs are evaluated by different stakeholders, including statisticians, clinicians, regulators, and development teams.
Finally, the course will address the broader strategic value of adaptive designs in drug development. Adaptive methods should not be viewed merely as technical tools, but as part of a broader framework for managing uncertainty, improving development efficiency, and aligning evidence generation with decision-making needs. Participants will come away with a clearer understanding of the opportunities, limitations, and implementation requirements of adaptive clinical trials, as well as a more informed perspective on when their use is scientifically and strategically justified.
Cost
Early Bird PSI Members: £180 +VAT PSI Members: £210 +VAT
Early Bird Non-PSI Members: £290 +VAT Non-PSI Members: £320 +VAT *Please note: Non-Member rates include PSI membership until 31 Dec. 2027.
Registration
Early Bird registration closes on Friday 28th August. To register for this event, please click here.
Speaker details
Speaker
Biography
Frank Bretz, Novartis
Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has contributed to methodological advancements in several areas of drug development, including adaptive designs, dose finding, estimands, and multiple testing. He was a member of the ICH E9(R1) Expert Working Group on “Estimands and sensitivity analysis in clinical trials”, a subject matter expert for the ICH M11 Expert Working Group on “Clinical electronic structured harmonised protocol”, and currently serves on the ICH E20 Expert Working Group on “Adaptive designs for clinical trials”.
Hans Ulrich Burger, Hoffmann- La Roche
Hans Ulrich Burger worked for more than 30 years at Hoffmann- La Roche in Basel as a statistician in various positions and therapeutic areas. He has experience in early and late drug development and contributed to a lot of clinical trials including trials with an adaptive design. He was involved from the beginning in the organization of the EFSPI regulatory statistics workshop and many other seminars and conferences. He currently serves on the ICH E20 Expert Working Group on adaptive designs in clinical trials, and is one of the three editors in chief of the Biometrical Journal.
Upcoming Events
PSI Book Club: Change: How organisations achieve hard-to-imagine results in uncertain and volatile times
Organizations have to adapt to the transforming landscape of our industry to ensure they continue to be successful in the future. Many of us are feeling the impact of organizational change. By reading John P Kotter’s book we can understand about organizational change and learn how to thrive, rather than just survive, through change.
Change, by John P Kotter (and his team), is a summary of all that he has learned over his decades of research and leading change. His book describes why many current approaches to change are inadequate and explains why new solutions need to give people a voice and a role in a new, change-embracing organization.
Develop your understanding of organisational change and become empowered to be part of your organisation’s change, by reading Change by John P Kotter and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply knowledge from the book in-between sessions.
PSI Vaccines SIG Webinar: Statistical Immune Correlate Analysis of Hemagglutination Inhibition Titers for an mRNA-based Influenza Vaccine
This 1-hour webinar is designed for statisticians with an interest in vaccine development, to learn about the recent application of statistical immune correlate analysis in vaccine development. Specifically, an application of such analyses to evaluate hemagglutination inhibition titers for an influenza vaccine
PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics
Date: Wednesday 4th November 2026
A careers talk about medical statistics and how it plays a crucial role in developing new medicines. Learn about the field of medical statistics and how it plays a crucial role in developing groundbreaking new medicines, vaccines and healthcare products.
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.
Date: 18 November 2026
This is an excellent opportunity for students to find out more about the field of medical statistics, talk to people from different organisations and make contacts for the future. All students currently studying for a mathematics or statistics-related BSc, MSc or PhD are invited to attend, and we welcome interest from exhibitors too.
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.
Aligning Estimation with the Clinical Question of Interest
This webinar will focus on aligning estimation to estimands. How do different strategies for handling intercurrent events and missing data handling influence the choice of estimation method, with illustration using a case study.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Careers Coaching Series: Peer Support Initiative
This 10-month peer support programme is aimed at professionals with five or more years of experience who are seeking structured development and connection with peers at a similar career stage. Through 5 bi-monthly topics, participants will engage in coach-led presentations, small-group discussions, and regular progress reviews focused on achieving tangible outcomes.
What if your placement year meant more than observing from the sidelines? Join Novartis and spend 12 months working hands-on with real clinical trial and healthcare data, helping to advance medicines that could improve patients' lives.
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally.
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally.
