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.
- See more at: http://www.psiweb.org/events/past-events/2014/trials-and-errors-in-clinical-trials#sthash.rFHr9q9j.dpuf
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.
- See more at: http://www.psiweb.org/events/past-events/2014/trials-and-errors-in-clinical-trials#sthash.rFHr9q9j.dpuf
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.
- See more at: http://www.psiweb.org/events/past-events/2014/trials-and-errors-in-clinical-trials#sthash.rFHr9q9j.dpuf
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.
- See more at: http://www.psiweb.org/events/past-events/2014/trials-and-errors-in-clinical-trials#sthash.rFHr9q9j.dpuf
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.
- See more at: http://www.psiweb.org/events/past-events/2014/trials-and-errors-in-clinical-trials#sthash.rFHr9q9j.dpuf
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.
- See more at: http://www.psiweb.org/events/past-events/2014/trials-and-errors-in-clinical-trials#sthash.rFHr9q9j.dpuf
Upcoming Events
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
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 Introduction to Industry Training (ITIT) Course - 2024/2025
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.
PSI Training Course: Regulatory Guidelines for Statisticians
This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
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 apprenticeship role offers a unique opportunity to learn and work in a global healthcare consultancy company alongside a team of statisticians, psychometricians and programmers.
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