The 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.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
The 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.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
The 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.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
The 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.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
The 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.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
The 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.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
We will do our best to discuss them at the webinar.
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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.
Topic: R Package Basics.
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, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.
Date: Ongoing 6 month cycle beginning late April/early May 2026
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event!
Haven’t read the book yet? Pick up a copy today and join us.
Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.