Use of Simulation in Clinical Trial Design

PSI Introduction to Industry Training (ITIT) Course - 2026/2027

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.

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.

AIMS SIG - Open-Source Lunch Bites

Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “Graphics Basics,” will introduce the fundamentals of producing graphics using the ggplot2 package.

PSI Career Young Virtual Event (Q2 2026)

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 Book Club: The AI Con – Joint with ASA Book Club

The Guardian described the authors of this book as refreshingly sarcastic! What is sold to us as AI, they announce, is just "a bill of goods": "A few major well-placed players are poised to accumulate significant wealth by extracting value from other people's creative work, personal data, or labour, and replacing quality services with artificial facsimiles."

PSI Book Club: Another Door Opens – Book Club Special Event

This is a Book Club Special Event in response to the changes in our industry and as a supportive move to create community and connection for those navigating redundancy and uncertainty. Read the book in advance of the book club session then join the zoom call to discuss ideas. There will be breakout groups to connect with others, exchange experiences of how the book has helped, and offer support.

PSI Book Club: Change: How organisations achieve hard-to-image results in uncertain and volatile times

Organizations have to adapt to the transforming landscape of our industry to ensure they continue to be successful in the future. Many of us are feeling the impact of organizational change. By reading John P Kotter’s book we can understand about organizational change and learn how to thrive, rather than just survive, through change. Change, by John P Kotter (and his team), is a summary of all that he has learned over his decades of research and leading change. His book describes why many current approaches to change are inadequate and explains why new solutions need to give people a voice and a role in a new, change-embracing organization. Develop your understanding of organisational change and become empowered to be part of your organisation’s change, by reading Change by John P Kotter and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply knowledge from the book in-between sessions.

PSI Career Young Virtual Event (Q3 2026)

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 Career Young Virtual Event (Q4 2026)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Time	Session	Speaker	Abstract	Slides
8:50	Registration & Coffee
9:10	Welcome & Introduction
9:15	What’s new in simulation	Benoit Beck (Axiosis)	TBC
10:00	Best practice in modelling and simulation: initiatives from PSI and EFPIA	Michael O’Kelly (Quintiles)	At an EMA-IFPIA workshop on modelling and simulation in 2011, regulators called for a Best Practice document for projects involving modelling and simulation. Finally, in the last few months, two different working groups have come up with two tools aimed at helping statisticians and their colleagues to promote and use best practice. The European Federation of Pharmaceutical Industries & Associations (EFPIA) working group on Model Informed Drug Discovery and Development (MID3) has just published a wide-ranging 90-page paper on the whys and hows of Best Practice. The paper includes as a supplement a table of 103 examples of the use of modelling and simulation in pharmaceutical science. At the same time, the Board of PSI in December adopted a Best Practice document proposed by the PSI Modelling and Simulation Special Interest Group (SIG). The two initiatives are consistent in their recommendations, with the SIG providing a template that could be used to put the recommendations for best practice into action. This presentation will identify the elements necessary for best practice in simulation of clinical trials, and survey current practice in this area.
10:45	Tea & Coffee
11:15	Writing Clinical Trial Simulators: there’s more to it than the stats analysis.	Tom Parke (Berry Consultants)	When writing ones first trial simulator it’s inevitable that one’s focus (as a stats programmer) is on the novel aspect of the trial design that has required writing a simulator in the first place. However there are other aspects of trial simulation that will end up as being every bit as important. By understanding these other aspects in advance you’ll be able to better plan to accommodate them and do a better job of writing and using a trial simulator.
12:00	Assessment of various continual reassessment method models for dose-escalation phase 1 oncology clinical trials: Clinical trial data and simulation studies	Gareth James (Phastar)	Background: The continual reassessment method (CRM) is considered more efficient and ethical than standard methods for dose-escalation trials in oncology, but requires an underlying estimate of the dose-toxicity relationship (“prior skeleton”) and there is limited guidance of what this should be when little is known about this association. Aim: To compare the CRM with different prior skeleton approaches and the 3+3 method in their ability to determine the true maximum tolerated dose (MTD) of various “true” dose-toxicity relationships.
12:45	Lunch
13:45	Simulating Dose Finding Designs using Bayesian Decisions, with examples for Severe Asthma, Ulcerative Colitis and Alzheimer’s Disease.	Alun Bedding (AZ)	Choosing the correct dose for Phase III is a pivotal part of drug development. Model based approaches are the most appropriate way of doing this and Bayesian decisions are more informative. Simulation is needed in order to understand the operating characteristics of designs given different assumptions. Examples, including those for severe asthma, ulcerative colitis and Alzheimer’s disease will be used for illustration.
14:30	Use of simulations to aid decision making	Jane Temple (GSK)	In clinical trial design we often use simulations to illustrate operational characteristics where analytical solutions are intractable. In this talk we will look at some case studies where these simulations have aided decision making and so increased understanding within the project team. We will look at an example of complex go/no go criteria and how these criteria were refined based on the results of the simulation. We will look at an example of how simulations were used to explore the impact of partial data on the operational characteristics of a futility analysis.
15:15	Tea & Coffee
15:45	Simulating a sequences of clinical trials - a whole drug development program, in order to optimize the design, planning and resource allocation	Tom Parke (Berry Consultants)	It’s hard to judge how big a phase 2 should be, what the trade off in power and type error should be, and what the significance of other post phase 2 errors (such dose selection, population selection, estimate of effect size) might be, without considering the whole picture of time to registration, overall probability of technical success and overall value / clinical usefulness should the treatment be successfully registered.
14:30	Close

Registration Costs
Registration on or before 4^th April
PSI Member	£120 (plus VAT)
Non-Member	£160 (plus VAT)
Academic	£60 (plus VAT)
Registration after 4^th April
PSI Member	£160 (plus VAT)
Non-Member	£220 (plus VAT)
Academic	£90 (plus VAT)
Fee includes lunch & refreshments

Time	Session	Speaker	Abstract	Slides
8:50	Registration & Coffee
9:10	Welcome & Introduction
9:15	What’s new in simulation	Benoit Beck (Axiosis)	TBC
10:00	Best practice in modelling and simulation: initiatives from PSI and EFPIA	Michael O’Kelly (Quintiles)	At an EMA-IFPIA workshop on modelling and simulation in 2011, regulators called for a Best Practice document for projects involving modelling and simulation. Finally, in the last few months, two different working groups have come up with two tools aimed at helping statisticians and their colleagues to promote and use best practice. The European Federation of Pharmaceutical Industries & Associations (EFPIA) working group on Model Informed Drug Discovery and Development (MID3) has just published a wide-ranging 90-page paper on the whys and hows of Best Practice. The paper includes as a supplement a table of 103 examples of the use of modelling and simulation in pharmaceutical science. At the same time, the Board of PSI in December adopted a Best Practice document proposed by the PSI Modelling and Simulation Special Interest Group (SIG). The two initiatives are consistent in their recommendations, with the SIG providing a template that could be used to put the recommendations for best practice into action. This presentation will identify the elements necessary for best practice in simulation of clinical trials, and survey current practice in this area.
10:45	Tea & Coffee
11:15	Writing Clinical Trial Simulators: there’s more to it than the stats analysis.	Tom Parke (Berry Consultants)	When writing ones first trial simulator it’s inevitable that one’s focus (as a stats programmer) is on the novel aspect of the trial design that has required writing a simulator in the first place. However there are other aspects of trial simulation that will end up as being every bit as important. By understanding these other aspects in advance you’ll be able to better plan to accommodate them and do a better job of writing and using a trial simulator.
12:00	Assessment of various continual reassessment method models for dose-escalation phase 1 oncology clinical trials: Clinical trial data and simulation studies	Gareth James (Phastar)	Background: The continual reassessment method (CRM) is considered more efficient and ethical than standard methods for dose-escalation trials in oncology, but requires an underlying estimate of the dose-toxicity relationship (“prior skeleton”) and there is limited guidance of what this should be when little is known about this association. Aim: To compare the CRM with different prior skeleton approaches and the 3+3 method in their ability to determine the true maximum tolerated dose (MTD) of various “true” dose-toxicity relationships.
12:45	Lunch
13:45	Simulating Dose Finding Designs using Bayesian Decisions, with examples for Severe Asthma, Ulcerative Colitis and Alzheimer’s Disease.	Alun Bedding (AZ)	Choosing the correct dose for Phase III is a pivotal part of drug development. Model based approaches are the most appropriate way of doing this and Bayesian decisions are more informative. Simulation is needed in order to understand the operating characteristics of designs given different assumptions. Examples, including those for severe asthma, ulcerative colitis and Alzheimer’s disease will be used for illustration.
14:30	Use of simulations to aid decision making	Jane Temple (GSK)	In clinical trial design we often use simulations to illustrate operational characteristics where analytical solutions are intractable. In this talk we will look at some case studies where these simulations have aided decision making and so increased understanding within the project team. We will look at an example of complex go/no go criteria and how these criteria were refined based on the results of the simulation. We will look at an example of how simulations were used to explore the impact of partial data on the operational characteristics of a futility analysis.
15:15	Tea & Coffee
15:45	Simulating a sequences of clinical trials - a whole drug development program, in order to optimize the design, planning and resource allocation	Tom Parke (Berry Consultants)	It’s hard to judge how big a phase 2 should be, what the trade off in power and type error should be, and what the significance of other post phase 2 errors (such dose selection, population selection, estimate of effect size) might be, without considering the whole picture of time to registration, overall probability of technical success and overall value / clinical usefulness should the treatment be successfully registered.
14:30	Close

Registration Costs
Registration on or before 4^th April
PSI Member	£120 (plus VAT)
Non-Member	£160 (plus VAT)
Academic	£60 (plus VAT)
Registration after 4^th April
PSI Member	£160 (plus VAT)
Non-Member	£220 (plus VAT)
Academic	£90 (plus VAT)
Fee includes lunch & refreshments

Time	Session	Speaker	Abstract	Slides
8:50	Registration & Coffee
9:10	Welcome & Introduction
9:15	What’s new in simulation	Benoit Beck (Axiosis)	TBC
10:00	Best practice in modelling and simulation: initiatives from PSI and EFPIA	Michael O’Kelly (Quintiles)	At an EMA-IFPIA workshop on modelling and simulation in 2011, regulators called for a Best Practice document for projects involving modelling and simulation. Finally, in the last few months, two different working groups have come up with two tools aimed at helping statisticians and their colleagues to promote and use best practice. The European Federation of Pharmaceutical Industries & Associations (EFPIA) working group on Model Informed Drug Discovery and Development (MID3) has just published a wide-ranging 90-page paper on the whys and hows of Best Practice. The paper includes as a supplement a table of 103 examples of the use of modelling and simulation in pharmaceutical science. At the same time, the Board of PSI in December adopted a Best Practice document proposed by the PSI Modelling and Simulation Special Interest Group (SIG). The two initiatives are consistent in their recommendations, with the SIG providing a template that could be used to put the recommendations for best practice into action. This presentation will identify the elements necessary for best practice in simulation of clinical trials, and survey current practice in this area.
10:45	Tea & Coffee
11:15	Writing Clinical Trial Simulators: there’s more to it than the stats analysis.	Tom Parke (Berry Consultants)	When writing ones first trial simulator it’s inevitable that one’s focus (as a stats programmer) is on the novel aspect of the trial design that has required writing a simulator in the first place. However there are other aspects of trial simulation that will end up as being every bit as important. By understanding these other aspects in advance you’ll be able to better plan to accommodate them and do a better job of writing and using a trial simulator.
12:00	Assessment of various continual reassessment method models for dose-escalation phase 1 oncology clinical trials: Clinical trial data and simulation studies	Gareth James (Phastar)	Background: The continual reassessment method (CRM) is considered more efficient and ethical than standard methods for dose-escalation trials in oncology, but requires an underlying estimate of the dose-toxicity relationship (“prior skeleton”) and there is limited guidance of what this should be when little is known about this association. Aim: To compare the CRM with different prior skeleton approaches and the 3+3 method in their ability to determine the true maximum tolerated dose (MTD) of various “true” dose-toxicity relationships.
12:45	Lunch
13:45	Simulating Dose Finding Designs using Bayesian Decisions, with examples for Severe Asthma, Ulcerative Colitis and Alzheimer’s Disease.	Alun Bedding (AZ)	Choosing the correct dose for Phase III is a pivotal part of drug development. Model based approaches are the most appropriate way of doing this and Bayesian decisions are more informative. Simulation is needed in order to understand the operating characteristics of designs given different assumptions. Examples, including those for severe asthma, ulcerative colitis and Alzheimer’s disease will be used for illustration.
14:30	Use of simulations to aid decision making	Jane Temple (GSK)	In clinical trial design we often use simulations to illustrate operational characteristics where analytical solutions are intractable. In this talk we will look at some case studies where these simulations have aided decision making and so increased understanding within the project team. We will look at an example of complex go/no go criteria and how these criteria were refined based on the results of the simulation. We will look at an example of how simulations were used to explore the impact of partial data on the operational characteristics of a futility analysis.
15:15	Tea & Coffee
15:45	Simulating a sequences of clinical trials - a whole drug development program, in order to optimize the design, planning and resource allocation	Tom Parke (Berry Consultants)	It’s hard to judge how big a phase 2 should be, what the trade off in power and type error should be, and what the significance of other post phase 2 errors (such dose selection, population selection, estimate of effect size) might be, without considering the whole picture of time to registration, overall probability of technical success and overall value / clinical usefulness should the treatment be successfully registered.
14:30	Close

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