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.
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
This will be a 45 minute webinar which will explain the topic presented in the published paper, ‘Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance’. There will be 15 minutes for a panel Q&A with some of the authors following the presentation.
This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.
This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.
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