This webinar aims to take a practical approach to some of the trials and errors seen in Clinical Trials. The webinar will go through some real life examples of where trials and statistical analyses may not have gone as expected! As well as covering some of the errors often seen by the MHRA whilst reviewing submissions.
Trials and Errors in Submissions: A Regulatory Perspective
Yolanda Barbachano (MHRA)
Working in a regulatory agency means seeing dossiers from a variety of companies and disease areas. There are some statistical issues that keep appearing again and again, such as the choice of analysis population, whilst other problems are more unusual but often more important. This talk will describe some of the statistical issues regulators come across when assessing dossiers for marketing authorisation applications and how some of these problems could be avoided. Topics covered will include the choice of analysis populations, missing data, sensitivity analyses and the use of long term extension studies to establish efficacy.
An example of Issues with Multiplicity Adjustments
Sophie Dimonaco (Roche)
There are many well-documented methods to control for multiplicity in clinical trials, all with their own set of pros and cons. This presentation will go through a real life example of a Phase III trial investigating three active treatment arms versus a control, where the chosen multiplicity method was Hierarchical Testing, with a chain of >40 endpoints. The aim of the presentation is to explain the rationale of why this multiplicity methodology was chosen, what happened when the chain broke early and the many discussions within the team post database lock about whether we had used the right adjustment method and what that meant for data with very important clinical significance that was statistically significant after the chain break.
Submission Challenges: A real life example (Working Title)
David Lawrence (Novarits)
David will be speaking regarding his experience of a recent phase 2/3 adaptive design trial which received a licence in the EU but not from the FDA. (Further details TBC)
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to the Trials & Errors in Clinical Trials webinar, or any of the listed talks, ahead of the webinar, please email them to Lucy.rowell@roche.com and Chris.Saville@iconplc.com
We will do our best to discuss them at the webinar.
This webinar aims to take a practical approach to some of the trials and errors seen in Clinical Trials. The webinar will go through some real life examples of where trials and statistical analyses may not have gone as expected! As well as covering some of the errors often seen by the MHRA whilst reviewing submissions.
Trials and Errors in Submissions: A Regulatory Perspective
Yolanda Barbachano (MHRA)
Working in a regulatory agency means seeing dossiers from a variety of companies and disease areas. There are some statistical issues that keep appearing again and again, such as the choice of analysis population, whilst other problems are more unusual but often more important. This talk will describe some of the statistical issues regulators come across when assessing dossiers for marketing authorisation applications and how some of these problems could be avoided. Topics covered will include the choice of analysis populations, missing data, sensitivity analyses and the use of long term extension studies to establish efficacy.
An example of Issues with Multiplicity Adjustments
Sophie Dimonaco (Roche)
There are many well-documented methods to control for multiplicity in clinical trials, all with their own set of pros and cons. This presentation will go through a real life example of a Phase III trial investigating three active treatment arms versus a control, where the chosen multiplicity method was Hierarchical Testing, with a chain of >40 endpoints. The aim of the presentation is to explain the rationale of why this multiplicity methodology was chosen, what happened when the chain broke early and the many discussions within the team post database lock about whether we had used the right adjustment method and what that meant for data with very important clinical significance that was statistically significant after the chain break.
Submission Challenges: A real life example (Working Title)
David Lawrence (Novarits)
David will be speaking regarding his experience of a recent phase 2/3 adaptive design trial which received a licence in the EU but not from the FDA. (Further details TBC)
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to the Trials & Errors in Clinical Trials webinar, or any of the listed talks, ahead of the webinar, please email them to Lucy.rowell@roche.com and Chris.Saville@iconplc.com
We will do our best to discuss them at the webinar.
This webinar aims to take a practical approach to some of the trials and errors seen in Clinical Trials. The webinar will go through some real life examples of where trials and statistical analyses may not have gone as expected! As well as covering some of the errors often seen by the MHRA whilst reviewing submissions.
Trials and Errors in Submissions: A Regulatory Perspective
Yolanda Barbachano (MHRA)
Working in a regulatory agency means seeing dossiers from a variety of companies and disease areas. There are some statistical issues that keep appearing again and again, such as the choice of analysis population, whilst other problems are more unusual but often more important. This talk will describe some of the statistical issues regulators come across when assessing dossiers for marketing authorisation applications and how some of these problems could be avoided. Topics covered will include the choice of analysis populations, missing data, sensitivity analyses and the use of long term extension studies to establish efficacy.
An example of Issues with Multiplicity Adjustments
Sophie Dimonaco (Roche)
There are many well-documented methods to control for multiplicity in clinical trials, all with their own set of pros and cons. This presentation will go through a real life example of a Phase III trial investigating three active treatment arms versus a control, where the chosen multiplicity method was Hierarchical Testing, with a chain of >40 endpoints. The aim of the presentation is to explain the rationale of why this multiplicity methodology was chosen, what happened when the chain broke early and the many discussions within the team post database lock about whether we had used the right adjustment method and what that meant for data with very important clinical significance that was statistically significant after the chain break.
Submission Challenges: A real life example (Working Title)
David Lawrence (Novarits)
David will be speaking regarding his experience of a recent phase 2/3 adaptive design trial which received a licence in the EU but not from the FDA. (Further details TBC)
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to the Trials & Errors in Clinical Trials webinar, or any of the listed talks, ahead of the webinar, please email them to Lucy.rowell@roche.com and Chris.Saville@iconplc.com
We will do our best to discuss them at the webinar.
This webinar aims to take a practical approach to some of the trials and errors seen in Clinical Trials. The webinar will go through some real life examples of where trials and statistical analyses may not have gone as expected! As well as covering some of the errors often seen by the MHRA whilst reviewing submissions.
Trials and Errors in Submissions: A Regulatory Perspective
Yolanda Barbachano (MHRA)
Working in a regulatory agency means seeing dossiers from a variety of companies and disease areas. There are some statistical issues that keep appearing again and again, such as the choice of analysis population, whilst other problems are more unusual but often more important. This talk will describe some of the statistical issues regulators come across when assessing dossiers for marketing authorisation applications and how some of these problems could be avoided. Topics covered will include the choice of analysis populations, missing data, sensitivity analyses and the use of long term extension studies to establish efficacy.
An example of Issues with Multiplicity Adjustments
Sophie Dimonaco (Roche)
There are many well-documented methods to control for multiplicity in clinical trials, all with their own set of pros and cons. This presentation will go through a real life example of a Phase III trial investigating three active treatment arms versus a control, where the chosen multiplicity method was Hierarchical Testing, with a chain of >40 endpoints. The aim of the presentation is to explain the rationale of why this multiplicity methodology was chosen, what happened when the chain broke early and the many discussions within the team post database lock about whether we had used the right adjustment method and what that meant for data with very important clinical significance that was statistically significant after the chain break.
Submission Challenges: A real life example (Working Title)
David Lawrence (Novarits)
David will be speaking regarding his experience of a recent phase 2/3 adaptive design trial which received a licence in the EU but not from the FDA. (Further details TBC)
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to the Trials & Errors in Clinical Trials webinar, or any of the listed talks, ahead of the webinar, please email them to Lucy.rowell@roche.com and Chris.Saville@iconplc.com
We will do our best to discuss them at the webinar.
This webinar aims to take a practical approach to some of the trials and errors seen in Clinical Trials. The webinar will go through some real life examples of where trials and statistical analyses may not have gone as expected! As well as covering some of the errors often seen by the MHRA whilst reviewing submissions.
Trials and Errors in Submissions: A Regulatory Perspective
Yolanda Barbachano (MHRA)
Working in a regulatory agency means seeing dossiers from a variety of companies and disease areas. There are some statistical issues that keep appearing again and again, such as the choice of analysis population, whilst other problems are more unusual but often more important. This talk will describe some of the statistical issues regulators come across when assessing dossiers for marketing authorisation applications and how some of these problems could be avoided. Topics covered will include the choice of analysis populations, missing data, sensitivity analyses and the use of long term extension studies to establish efficacy.
An example of Issues with Multiplicity Adjustments
Sophie Dimonaco (Roche)
There are many well-documented methods to control for multiplicity in clinical trials, all with their own set of pros and cons. This presentation will go through a real life example of a Phase III trial investigating three active treatment arms versus a control, where the chosen multiplicity method was Hierarchical Testing, with a chain of >40 endpoints. The aim of the presentation is to explain the rationale of why this multiplicity methodology was chosen, what happened when the chain broke early and the many discussions within the team post database lock about whether we had used the right adjustment method and what that meant for data with very important clinical significance that was statistically significant after the chain break.
Submission Challenges: A real life example (Working Title)
David Lawrence (Novarits)
David will be speaking regarding his experience of a recent phase 2/3 adaptive design trial which received a licence in the EU but not from the FDA. (Further details TBC)
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to the Trials & Errors in Clinical Trials webinar, or any of the listed talks, ahead of the webinar, please email them to Lucy.rowell@roche.com and Chris.Saville@iconplc.com
We will do our best to discuss them at the webinar.
This webinar aims to take a practical approach to some of the trials and errors seen in Clinical Trials. The webinar will go through some real life examples of where trials and statistical analyses may not have gone as expected! As well as covering some of the errors often seen by the MHRA whilst reviewing submissions.
Trials and Errors in Submissions: A Regulatory Perspective
Yolanda Barbachano (MHRA)
Working in a regulatory agency means seeing dossiers from a variety of companies and disease areas. There are some statistical issues that keep appearing again and again, such as the choice of analysis population, whilst other problems are more unusual but often more important. This talk will describe some of the statistical issues regulators come across when assessing dossiers for marketing authorisation applications and how some of these problems could be avoided. Topics covered will include the choice of analysis populations, missing data, sensitivity analyses and the use of long term extension studies to establish efficacy.
An example of Issues with Multiplicity Adjustments
Sophie Dimonaco (Roche)
There are many well-documented methods to control for multiplicity in clinical trials, all with their own set of pros and cons. This presentation will go through a real life example of a Phase III trial investigating three active treatment arms versus a control, where the chosen multiplicity method was Hierarchical Testing, with a chain of >40 endpoints. The aim of the presentation is to explain the rationale of why this multiplicity methodology was chosen, what happened when the chain broke early and the many discussions within the team post database lock about whether we had used the right adjustment method and what that meant for data with very important clinical significance that was statistically significant after the chain break.
Submission Challenges: A real life example (Working Title)
David Lawrence (Novarits)
David will be speaking regarding his experience of a recent phase 2/3 adaptive design trial which received a licence in the EU but not from the FDA. (Further details TBC)
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to the Trials & Errors in Clinical Trials webinar, or any of the listed talks, ahead of the webinar, please email them to Lucy.rowell@roche.com and Chris.Saville@iconplc.com
We will do our best to discuss them at the webinar.
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.
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.
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.
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.
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.
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: Wednesday 5th November 2025 A careers talk about medical statistics and how it plays a crucial role in developing new medicines
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.
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.
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.
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.
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
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