Date: Wednesday 26th January 2022 Time: 14:00-15:00 GMT Speakers: Kevin Ding (AstraZeneca) and Juan Abellan (GSK)
Who is this event intended for? Statisticians working on regulatory submissions What is the benefit of attending? To learn more about the 'how' and 'why' of tipping point analysis, using relevant examples from previous studies.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = £20+VAT
To register for the session, please click here.
Overview
To assess the strength of clinical study findings, regulatory authorities often request tipping point analyses. However what is a tipping point analysis, and how is one performed? What are the different approaches for continuous, binary and time to event data? Kevin and Juan present some practical examples.
To view the flyer for this event, please click here.
Speaker details
Speaker
Biography
Abstract
Juan Abellan
Juan is a statistician by training, by experience and by passion. He studied Maths and Stats and did his PhD at the University of Valencia (Spain), and worked as a research fellow at Imperial College London. He has worked as a statistician in various roles in Public Offices, Academia and Industry in Spain, Germany and the UK. He's currently a GSK fellow and Statistics Director at the Statistics and Data Science Innovation Hub, based in London. His current main interests include the use of Bayesian thinking for better quantitative decision making in drug development, estimands and their estimation in the presence of missing data and the analysis of data collected with digital wearable technologies.
Tipping point sensitivity analysis for time-to-event: a case study in belimumab
In this presentation I will illustrate one way of implementing a tipping point analysis (TPA) for a time-to-event endpoint to assess the robustness of results to the censoring-at-random assumption. The method is based on multiple imputation and it assumes the hazard rate post-censoring changes. A grid of values reflecting such changes is considered to vary the hazard rate post-censoring independently for each treatment arm. The (experimental, control) pairs of post-censoring hazard rate changes form the TPA scenarios. Within each of the TPA scenarios, participants who are censored are imputed a time to the event of interest and are administratively censored if the imputed time exceeds the length of the follow-up. Results are combined across imputed datasets using Rubin’s rules. Finally, the plausibility of the scenarios where the results tip is discussed.
Kevin Ding
Kevin has 13 years of industry experience of designing and implementing study design of clinical trials in the areas of both general medicine and oncology. Kevin previously worked in J&J (late phase oncology) and Novartis (late phase immunology) and now is working in AZ as Statistical Science Associate Director for early phase oncology. Kevin has 14 academic journal publications and has special research interest in practical use of estimand and approaches of dealing with missing data in late phase trials. He presented “The Application of Tipping Point Analysis in Clinical Trials” in 2018 JSM meeting.
Practical use of Tipping Point Analysis in regulatory submissions of clinical trials
The tipping point analysis (TPA) approach has gained popularity recently as an approach for performing the sensitivity analysis under the missing not at random (MNAR) assumption. This presentation will review why TPA gets popular in clinical trial submissions, its implementation for binary endpoints for time-independent imputation and time-dependent imputation, general procedure of TPA implementation for continuous endpoints, and Interpretation of TPA result based on clinical input. The presentation then shows six real examples of FDA statistical review of submitted NDA/BLAs (all in public domain) that use TPA as sensitivity analysis to illustrate the practical use of this method in real trials and important consideration points from the regulatory perspective.
Scientific Meetings
PSI Webinar: Tipping Point Analyses - Introduction & Case Studies
Date: Wednesday 26th January 2022 Time: 14:00-15:00 GMT Speakers: Kevin Ding (AstraZeneca) and Juan Abellan (GSK)
Who is this event intended for? Statisticians working on regulatory submissions What is the benefit of attending? To learn more about the 'how' and 'why' of tipping point analysis, using relevant examples from previous studies.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = £20+VAT
To register for the session, please click here.
Overview
To assess the strength of clinical study findings, regulatory authorities often request tipping point analyses. However what is a tipping point analysis, and how is one performed? What are the different approaches for continuous, binary and time to event data? Kevin and Juan present some practical examples.
To view the flyer for this event, please click here.
Speaker details
Speaker
Biography
Abstract
Juan Abellan
Juan is a statistician by training, by experience and by passion. He studied Maths and Stats and did his PhD at the University of Valencia (Spain), and worked as a research fellow at Imperial College London. He has worked as a statistician in various roles in Public Offices, Academia and Industry in Spain, Germany and the UK. He's currently a GSK fellow and Statistics Director at the Statistics and Data Science Innovation Hub, based in London. His current main interests include the use of Bayesian thinking for better quantitative decision making in drug development, estimands and their estimation in the presence of missing data and the analysis of data collected with digital wearable technologies.
Tipping point sensitivity analysis for time-to-event: a case study in belimumab
In this presentation I will illustrate one way of implementing a tipping point analysis (TPA) for a time-to-event endpoint to assess the robustness of results to the censoring-at-random assumption. The method is based on multiple imputation and it assumes the hazard rate post-censoring changes. A grid of values reflecting such changes is considered to vary the hazard rate post-censoring independently for each treatment arm. The (experimental, control) pairs of post-censoring hazard rate changes form the TPA scenarios. Within each of the TPA scenarios, participants who are censored are imputed a time to the event of interest and are administratively censored if the imputed time exceeds the length of the follow-up. Results are combined across imputed datasets using Rubin’s rules. Finally, the plausibility of the scenarios where the results tip is discussed.
Kevin Ding
Kevin has 13 years of industry experience of designing and implementing study design of clinical trials in the areas of both general medicine and oncology. Kevin previously worked in J&J (late phase oncology) and Novartis (late phase immunology) and now is working in AZ as Statistical Science Associate Director for early phase oncology. Kevin has 14 academic journal publications and has special research interest in practical use of estimand and approaches of dealing with missing data in late phase trials. He presented “The Application of Tipping Point Analysis in Clinical Trials” in 2018 JSM meeting.
Practical use of Tipping Point Analysis in regulatory submissions of clinical trials
The tipping point analysis (TPA) approach has gained popularity recently as an approach for performing the sensitivity analysis under the missing not at random (MNAR) assumption. This presentation will review why TPA gets popular in clinical trial submissions, its implementation for binary endpoints for time-independent imputation and time-dependent imputation, general procedure of TPA implementation for continuous endpoints, and Interpretation of TPA result based on clinical input. The presentation then shows six real examples of FDA statistical review of submitted NDA/BLAs (all in public domain) that use TPA as sensitivity analysis to illustrate the practical use of this method in real trials and important consideration points from the regulatory perspective.
Training Courses
PSI Webinar: Tipping Point Analyses - Introduction & Case Studies
Date: Wednesday 26th January 2022 Time: 14:00-15:00 GMT Speakers: Kevin Ding (AstraZeneca) and Juan Abellan (GSK)
Who is this event intended for? Statisticians working on regulatory submissions What is the benefit of attending? To learn more about the 'how' and 'why' of tipping point analysis, using relevant examples from previous studies.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = £20+VAT
To register for the session, please click here.
Overview
To assess the strength of clinical study findings, regulatory authorities often request tipping point analyses. However what is a tipping point analysis, and how is one performed? What are the different approaches for continuous, binary and time to event data? Kevin and Juan present some practical examples.
To view the flyer for this event, please click here.
Speaker details
Speaker
Biography
Abstract
Juan Abellan
Juan is a statistician by training, by experience and by passion. He studied Maths and Stats and did his PhD at the University of Valencia (Spain), and worked as a research fellow at Imperial College London. He has worked as a statistician in various roles in Public Offices, Academia and Industry in Spain, Germany and the UK. He's currently a GSK fellow and Statistics Director at the Statistics and Data Science Innovation Hub, based in London. His current main interests include the use of Bayesian thinking for better quantitative decision making in drug development, estimands and their estimation in the presence of missing data and the analysis of data collected with digital wearable technologies.
Tipping point sensitivity analysis for time-to-event: a case study in belimumab
In this presentation I will illustrate one way of implementing a tipping point analysis (TPA) for a time-to-event endpoint to assess the robustness of results to the censoring-at-random assumption. The method is based on multiple imputation and it assumes the hazard rate post-censoring changes. A grid of values reflecting such changes is considered to vary the hazard rate post-censoring independently for each treatment arm. The (experimental, control) pairs of post-censoring hazard rate changes form the TPA scenarios. Within each of the TPA scenarios, participants who are censored are imputed a time to the event of interest and are administratively censored if the imputed time exceeds the length of the follow-up. Results are combined across imputed datasets using Rubin’s rules. Finally, the plausibility of the scenarios where the results tip is discussed.
Kevin Ding
Kevin has 13 years of industry experience of designing and implementing study design of clinical trials in the areas of both general medicine and oncology. Kevin previously worked in J&J (late phase oncology) and Novartis (late phase immunology) and now is working in AZ as Statistical Science Associate Director for early phase oncology. Kevin has 14 academic journal publications and has special research interest in practical use of estimand and approaches of dealing with missing data in late phase trials. He presented “The Application of Tipping Point Analysis in Clinical Trials” in 2018 JSM meeting.
Practical use of Tipping Point Analysis in regulatory submissions of clinical trials
The tipping point analysis (TPA) approach has gained popularity recently as an approach for performing the sensitivity analysis under the missing not at random (MNAR) assumption. This presentation will review why TPA gets popular in clinical trial submissions, its implementation for binary endpoints for time-independent imputation and time-dependent imputation, general procedure of TPA implementation for continuous endpoints, and Interpretation of TPA result based on clinical input. The presentation then shows six real examples of FDA statistical review of submitted NDA/BLAs (all in public domain) that use TPA as sensitivity analysis to illustrate the practical use of this method in real trials and important consideration points from the regulatory perspective.
Journal Club
PSI Webinar: Tipping Point Analyses - Introduction & Case Studies
Date: Wednesday 26th January 2022 Time: 14:00-15:00 GMT Speakers: Kevin Ding (AstraZeneca) and Juan Abellan (GSK)
Who is this event intended for? Statisticians working on regulatory submissions What is the benefit of attending? To learn more about the 'how' and 'why' of tipping point analysis, using relevant examples from previous studies.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = £20+VAT
To register for the session, please click here.
Overview
To assess the strength of clinical study findings, regulatory authorities often request tipping point analyses. However what is a tipping point analysis, and how is one performed? What are the different approaches for continuous, binary and time to event data? Kevin and Juan present some practical examples.
To view the flyer for this event, please click here.
Speaker details
Speaker
Biography
Abstract
Juan Abellan
Juan is a statistician by training, by experience and by passion. He studied Maths and Stats and did his PhD at the University of Valencia (Spain), and worked as a research fellow at Imperial College London. He has worked as a statistician in various roles in Public Offices, Academia and Industry in Spain, Germany and the UK. He's currently a GSK fellow and Statistics Director at the Statistics and Data Science Innovation Hub, based in London. His current main interests include the use of Bayesian thinking for better quantitative decision making in drug development, estimands and their estimation in the presence of missing data and the analysis of data collected with digital wearable technologies.
Tipping point sensitivity analysis for time-to-event: a case study in belimumab
In this presentation I will illustrate one way of implementing a tipping point analysis (TPA) for a time-to-event endpoint to assess the robustness of results to the censoring-at-random assumption. The method is based on multiple imputation and it assumes the hazard rate post-censoring changes. A grid of values reflecting such changes is considered to vary the hazard rate post-censoring independently for each treatment arm. The (experimental, control) pairs of post-censoring hazard rate changes form the TPA scenarios. Within each of the TPA scenarios, participants who are censored are imputed a time to the event of interest and are administratively censored if the imputed time exceeds the length of the follow-up. Results are combined across imputed datasets using Rubin’s rules. Finally, the plausibility of the scenarios where the results tip is discussed.
Kevin Ding
Kevin has 13 years of industry experience of designing and implementing study design of clinical trials in the areas of both general medicine and oncology. Kevin previously worked in J&J (late phase oncology) and Novartis (late phase immunology) and now is working in AZ as Statistical Science Associate Director for early phase oncology. Kevin has 14 academic journal publications and has special research interest in practical use of estimand and approaches of dealing with missing data in late phase trials. He presented “The Application of Tipping Point Analysis in Clinical Trials” in 2018 JSM meeting.
Practical use of Tipping Point Analysis in regulatory submissions of clinical trials
The tipping point analysis (TPA) approach has gained popularity recently as an approach for performing the sensitivity analysis under the missing not at random (MNAR) assumption. This presentation will review why TPA gets popular in clinical trial submissions, its implementation for binary endpoints for time-independent imputation and time-dependent imputation, general procedure of TPA implementation for continuous endpoints, and Interpretation of TPA result based on clinical input. The presentation then shows six real examples of FDA statistical review of submitted NDA/BLAs (all in public domain) that use TPA as sensitivity analysis to illustrate the practical use of this method in real trials and important consideration points from the regulatory perspective.
Webinars
PSI Webinar: Tipping Point Analyses - Introduction & Case Studies
Date: Wednesday 26th January 2022 Time: 14:00-15:00 GMT Speakers: Kevin Ding (AstraZeneca) and Juan Abellan (GSK)
Who is this event intended for? Statisticians working on regulatory submissions What is the benefit of attending? To learn more about the 'how' and 'why' of tipping point analysis, using relevant examples from previous studies.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = £20+VAT
To register for the session, please click here.
Overview
To assess the strength of clinical study findings, regulatory authorities often request tipping point analyses. However what is a tipping point analysis, and how is one performed? What are the different approaches for continuous, binary and time to event data? Kevin and Juan present some practical examples.
To view the flyer for this event, please click here.
Speaker details
Speaker
Biography
Abstract
Juan Abellan
Juan is a statistician by training, by experience and by passion. He studied Maths and Stats and did his PhD at the University of Valencia (Spain), and worked as a research fellow at Imperial College London. He has worked as a statistician in various roles in Public Offices, Academia and Industry in Spain, Germany and the UK. He's currently a GSK fellow and Statistics Director at the Statistics and Data Science Innovation Hub, based in London. His current main interests include the use of Bayesian thinking for better quantitative decision making in drug development, estimands and their estimation in the presence of missing data and the analysis of data collected with digital wearable technologies.
Tipping point sensitivity analysis for time-to-event: a case study in belimumab
In this presentation I will illustrate one way of implementing a tipping point analysis (TPA) for a time-to-event endpoint to assess the robustness of results to the censoring-at-random assumption. The method is based on multiple imputation and it assumes the hazard rate post-censoring changes. A grid of values reflecting such changes is considered to vary the hazard rate post-censoring independently for each treatment arm. The (experimental, control) pairs of post-censoring hazard rate changes form the TPA scenarios. Within each of the TPA scenarios, participants who are censored are imputed a time to the event of interest and are administratively censored if the imputed time exceeds the length of the follow-up. Results are combined across imputed datasets using Rubin’s rules. Finally, the plausibility of the scenarios where the results tip is discussed.
Kevin Ding
Kevin has 13 years of industry experience of designing and implementing study design of clinical trials in the areas of both general medicine and oncology. Kevin previously worked in J&J (late phase oncology) and Novartis (late phase immunology) and now is working in AZ as Statistical Science Associate Director for early phase oncology. Kevin has 14 academic journal publications and has special research interest in practical use of estimand and approaches of dealing with missing data in late phase trials. He presented “The Application of Tipping Point Analysis in Clinical Trials” in 2018 JSM meeting.
Practical use of Tipping Point Analysis in regulatory submissions of clinical trials
The tipping point analysis (TPA) approach has gained popularity recently as an approach for performing the sensitivity analysis under the missing not at random (MNAR) assumption. This presentation will review why TPA gets popular in clinical trial submissions, its implementation for binary endpoints for time-independent imputation and time-dependent imputation, general procedure of TPA implementation for continuous endpoints, and Interpretation of TPA result based on clinical input. The presentation then shows six real examples of FDA statistical review of submitted NDA/BLAs (all in public domain) that use TPA as sensitivity analysis to illustrate the practical use of this method in real trials and important consideration points from the regulatory perspective.
Careers Meetings
PSI Webinar: Tipping Point Analyses - Introduction & Case Studies
Date: Wednesday 26th January 2022 Time: 14:00-15:00 GMT Speakers: Kevin Ding (AstraZeneca) and Juan Abellan (GSK)
Who is this event intended for? Statisticians working on regulatory submissions What is the benefit of attending? To learn more about the 'how' and 'why' of tipping point analysis, using relevant examples from previous studies.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = £20+VAT
To register for the session, please click here.
Overview
To assess the strength of clinical study findings, regulatory authorities often request tipping point analyses. However what is a tipping point analysis, and how is one performed? What are the different approaches for continuous, binary and time to event data? Kevin and Juan present some practical examples.
To view the flyer for this event, please click here.
Speaker details
Speaker
Biography
Abstract
Juan Abellan
Juan is a statistician by training, by experience and by passion. He studied Maths and Stats and did his PhD at the University of Valencia (Spain), and worked as a research fellow at Imperial College London. He has worked as a statistician in various roles in Public Offices, Academia and Industry in Spain, Germany and the UK. He's currently a GSK fellow and Statistics Director at the Statistics and Data Science Innovation Hub, based in London. His current main interests include the use of Bayesian thinking for better quantitative decision making in drug development, estimands and their estimation in the presence of missing data and the analysis of data collected with digital wearable technologies.
Tipping point sensitivity analysis for time-to-event: a case study in belimumab
In this presentation I will illustrate one way of implementing a tipping point analysis (TPA) for a time-to-event endpoint to assess the robustness of results to the censoring-at-random assumption. The method is based on multiple imputation and it assumes the hazard rate post-censoring changes. A grid of values reflecting such changes is considered to vary the hazard rate post-censoring independently for each treatment arm. The (experimental, control) pairs of post-censoring hazard rate changes form the TPA scenarios. Within each of the TPA scenarios, participants who are censored are imputed a time to the event of interest and are administratively censored if the imputed time exceeds the length of the follow-up. Results are combined across imputed datasets using Rubin’s rules. Finally, the plausibility of the scenarios where the results tip is discussed.
Kevin Ding
Kevin has 13 years of industry experience of designing and implementing study design of clinical trials in the areas of both general medicine and oncology. Kevin previously worked in J&J (late phase oncology) and Novartis (late phase immunology) and now is working in AZ as Statistical Science Associate Director for early phase oncology. Kevin has 14 academic journal publications and has special research interest in practical use of estimand and approaches of dealing with missing data in late phase trials. He presented “The Application of Tipping Point Analysis in Clinical Trials” in 2018 JSM meeting.
Practical use of Tipping Point Analysis in regulatory submissions of clinical trials
The tipping point analysis (TPA) approach has gained popularity recently as an approach for performing the sensitivity analysis under the missing not at random (MNAR) assumption. This presentation will review why TPA gets popular in clinical trial submissions, its implementation for binary endpoints for time-independent imputation and time-dependent imputation, general procedure of TPA implementation for continuous endpoints, and Interpretation of TPA result based on clinical input. The presentation then shows six real examples of FDA statistical review of submitted NDA/BLAs (all in public domain) that use TPA as sensitivity analysis to illustrate the practical use of this method in real trials and important consideration points from the regulatory perspective.
Upcoming Events
PSI Training Course: Introduction to Machine Learning
This course is aimed at clinical trial statisticians who are new to or with limited experience of machine learning. Attendees will learn about a range of topics in machine learning, including practical sessions in R.
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.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
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.
Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
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.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
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