Date: Thursday 9th November 2023
Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET
Speakers: Kristian Brock and Peter Thall
Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy.
What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers:
1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
2. Yun Qing, Peter F. Thall, Ying Yuan: 'A Bayesian piecewise exponential phase II design for monitoring a time-to-event endpoint'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2256
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
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Speaker |
Biography |
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|
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes. |
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Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing. |
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Chair |
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Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development. |
Date: Thursday 9th November 2023
Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET
Speakers: Kristian Brock and Peter Thall
Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy.
What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers:
1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
2. Yun Qing, Peter F. Thall, Ying Yuan: 'A Bayesian piecewise exponential phase II design for monitoring a time-to-event endpoint'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2256
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
|
Speaker |
Biography |
|
|
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes. |
|
|
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing. |
|
Chair |
|
|
|
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development. |
Date: Thursday 9th November 2023
Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET
Speakers: Kristian Brock and Peter Thall
Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy.
What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers:
1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
2. Yun Qing, Peter F. Thall, Ying Yuan: 'A Bayesian piecewise exponential phase II design for monitoring a time-to-event endpoint'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2256
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
|
Speaker |
Biography |
|
|
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes. |
|
|
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing. |
|
Chair |
|
|
|
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development. |
Date: Thursday 9th November 2023
Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET
Speakers: Kristian Brock and Peter Thall
Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy.
What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers:
1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
2. Yun Qing, Peter F. Thall, Ying Yuan: 'A Bayesian piecewise exponential phase II design for monitoring a time-to-event endpoint'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2256
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
|
Speaker |
Biography |
|
|
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes. |
|
|
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing. |
|
Chair |
|
|
|
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development. |
Date: Thursday 9th November 2023
Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET
Speakers: Kristian Brock and Peter Thall
Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy.
What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers:
1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
2. Yun Qing, Peter F. Thall, Ying Yuan: 'A Bayesian piecewise exponential phase II design for monitoring a time-to-event endpoint'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2256
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
|
Speaker |
Biography |
|
|
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes. |
|
|
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing. |
|
Chair |
|
|
|
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development. |
Date: Thursday 9th November 2023
Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET
Speakers: Kristian Brock and Peter Thall
Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy.
What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers:
1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
2. Yun Qing, Peter F. Thall, Ying Yuan: 'A Bayesian piecewise exponential phase II design for monitoring a time-to-event endpoint'
https://onlinelibrary.wiley.com/doi/10.1002/pst.2256
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
|
Speaker |
Biography |
|
|
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes. |
|
|
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing. |
|
Chair |
|
|
|
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development. |
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.
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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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The Institute of Cancer Research are seeking to appoint a Research Group Leader to join The CRUK Clinical Trials and Statistics Unit at the ICR.
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