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.
The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.
This webinar is organised by the RWD SIG and the Historical Data SIG. We will review recent methods, applications, and tools of integrating subject-level-data from clinical trial with external data using Bayesian methods and/or causal inference methods.
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 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.
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.
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.
About cookies on this site
We use cookies to collect and analyse information on site performance and usage, to provide social media features and to enhance and customise content and advertisements.
About cookies on this site
Cookies used on the site are categorized and below you can read about each category and allow or deny some or all of them. When categories than have been previously allowed are disabled, all cookies assigned to that category will be removed from your browser. Additionally you can see a list of cookies assigned to each category and detailed information in the cookie declaration.
Necessary cookies
Some cookies are required to provide core functionality. The website won't function properly without these cookies and they are enabled by default and cannot be disabled.
CookieHub is a Consent Management Platform (CMP) which allows users to control storage and processing of personal information.
Cloudflare is a global network designed to make everything you connect to the Internet secure, private, fast, and reliable.
Amazon Web Services offers a broad set of global cloud-based products including compute, storage, databases, analytics, networking, mobile, developer tools, management tools, IoT, security, and enterprise applications.
Microsoft Azure is a cloud computing platform offering a wide range of services, including virtual machines, databases, and AI tools.
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.
Google Analytics is a web analytics service offered by Google that tracks and reports website traffic.
Vimeo, Inc. is an American video hosting, sharing, services provider, and broadcaster. Vimeo focuses on the delivery of high-definition video across a range of devices.
Cookies used on the site are categorized and below you can read about each category and allow or deny some or all of them. When categories than have been previously allowed are disabled, all cookies assigned to that category will be removed from your browser. Additionally you can see a list of cookies assigned to each category and detailed information in the cookie declaration.
Necessary cookies
Some cookies are required to provide core functionality. The website won't function properly without these cookies and they are enabled by default and cannot be disabled.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| ARRAffinity | .psiweb.org | Session | |
This cookie is set by websites run on the Windows Azure cloud platform. It is used for load balancing to make sure the visitor page requests are routed to the same server in any browsing session. | |||
| ARRAffinitySameSite | .psiweb.org | Session | |
Used to distribute traffic to the website on several servers in order to optimize response times. | |||
| __cf_bm | .vimeo.com | Cloudflare, Inc. | 1 hour |
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption. | |||
| _cfuvid | .vimeo.com | Session | |
Used by Cloudflare WAF to distinguish individual users who share the same IP address and apply rate limits | |||
| __cf_bm | .glueup.com | Cloudflare, Inc. | 1 hour |
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption. | |||
| AWSALBTGCORS | psi.glueup.com | 7 days | |
AWS Classic Load Balancer Cookie: Load Balancing Cookie: Used to map the session to the instance. Same value as AWSELB. | |||
| PHPSESSID | psi.glueup.com | Session | |
Cookie generated by applications based on the PHP language. This is a general purpose identifier used to maintain user session variables. It is normally a random generated number, how it is used can be specific to the site, but a good example is maintaining a logged-in status for a user between pages. | |||
| History.store | Session | ||
| cookiehub | .psiweb.org | CookieHub | 365 days |
Used by CookieHub to store information about whether visitors have given or declined the use of cookie categories used on the site. | |||
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| vuid | .vimeo.com | 400 days | |
These cookies are used by the Vimeo video player on websites. | |||
| AWSALBCORS | psi.glueup.com | 7 days | |
Amazon Web Services cookie. This cookie enables us to allocate server traffic to make the user experience as smooth as possible. A so-called load balancer is used to determine which server currently has the best availability. The information generated cannot identify you as an individual. | |||
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| _ga_ | .psiweb.org | 400 days | |
Contains a unique identifier used by Google Analytics 4 to determine that two distinct hits belong to the same user across browsing sessions. | |||
| _ga | .psiweb.org | 400 days | |
Contains a unique identifier used by Google Analytics to determine that two distinct hits belong to the same user across browsing sessions. | |||
