PSI Journal Club presents “Subgroup and Covariate Analysis”. Chaired by Chris Harbron with presentations from: Thomas Jemielita: - Investigating Stability in Subgroup Identification for Stratified Medicine and Björn Holzhauer: - “Super-covariates”: Using predicted control group outcome as a covariate in randomized clinical trials.

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Many cancer trials use the progression free survival as primary outcome measure, i.e. the length of time that a patient lives on without worsening of the disease. Various reasons can lead to censoring of the data. And differential censoring could influence the interpretation of the results. Paolo Eusebi presents visualisations that help to explore the pattern of events and reasons for censoring. Visualisations are available on the Wonderful Wednesday blog.

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The development of a new patient reported outcome (PRO) needs to include the interpretation of the results. It should be possible to define a minimal clinically important difference and a meaningful between-group difference. Rhys Warham is presenting ways how visualisations can support that process. They are available on the Wonderful Wednesday blog.

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This webinar will help listeners gain a broader understanding of a recent and rapidly advancing core area of pharmaceutical drug development. The content will be broad, but will focus on clinical design and analysis strategies for advanced therapeutics such as cell/gene therapies, and strategic options to advance candidate drugs in this space.

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This webinar follows up on last month's challenge on platform trial design. This time the impact of specific design changes is highlighted with effective visualisations. Bodo Kirsch is presenting examples for exploratory and explanatory visualisations. They are available on the Wonderful Wednesday blog.

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We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.

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1. Alessandra Serra 2. Andisheh Bakhshi 3. Daniel Clement 4. Luca Rondano 5. Marco Ratta

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Theo will guide us through the multifaceted world of neurodiversity. You will gain insights into: • The essence of Neurodiversity, an understanding of the spectrum of cognitive differences • The crucial Terminology that frames our conversations around it • Why Neurodiversity is a Hot Topic in today’s fast-evolving corporate landscape, • The Advantages of Neurodiverse Teams, where cognitive diversity can be a catalyst for creativity and efficiency • Strategies on How to Harness the Best from Team Members, fostering an environment where every individual thrives • The Challenges we face and how to navigate them with empathy and intelligence • Envisioning The Future of Neurodiversity in the workplace, where potential is not just recognised but celebrated and cultivated • And lastly, an interactive Panel Session, fostering a dialogue that sparks change Prepare to embark on a journey that challenges the status quo, embraces the power of diversity, and leads us toward a more inclusive and innovative future. Let's open our minds to the rich diversity of human thought as Theo Smith takes the stage.

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This session will cover the topic of decision making in clinical trials. One talk will discuss the use of quantitative decision making in designing trials and how it can outline inherent risk with a study design. Another talk will discuss assurance methods for survival trials with a delayed treatment effect in a Phase 3 oncology setting and present elicitation techniques on how to compute assurance. The third talk introduces the concept of "Detriment Index" as a novel ranking technique for drugs in the context of the management of pain in individuals with noncommunicable diseases, offering a comprehensive and evidence-based method for healthcare providers, researchers, and policymakers to evaluate and prioritize pain management strategies.

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With the centralized European Joint Clinical Assessment, Indirect Treatment Comparisons (ITCs) will play an integral role to show comparative evidence versus the national standard of care(s). Latest developments in ITC methodology on adjustment for measured and unmeasured confounding in ITCs and bias quantification will be presented in this session.

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Adaptive designs and complex clinical trials offer many well-known advantages throughout the clinical development process and their acceptance is steadily increasing. Typically, such designs use either the Bayesian or the frequent framework for decision making and reporting. While frequentist adaptive designs often have closed-form calculations of operating characteristics, Bayesian designs usually require simulations. On the other hand, Bayesian designs often make it easy to communicate results, incorporate multiple endpoints and achieve efficiency gains by using e.g., the predictive probability for interim decision making. Regardless of the choice of analysis method and the associated philosophical differences in the paradigms, there is an understanding that, among others, frequentist operating characteristics such as power and type 1 error are important to evaluate the proposed design. Ultimately, both Bayesian and frequentist adaptive designs aim to and should be judged by their ability to produce better and more efficient clinical trials without compromising their statistical integrity. In this session, we will bring together experts in the design of both Bayesian and frequentist adaptive trials, as well as a senior European regulator to learn more about recent methodological advances, regulatory considerations, and practical experiences when designing and assessing these trial designs

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Adaptive designs and complex clinical trials offer many well-known advantages throughout the clinical development process and their acceptance is steadily increasing. Typically, such designs use either the Bayesian or the frequent framework for decision making and reporting. While frequentist adaptive designs often have closed-form calculations of operating characteristics, Bayesian designs usually require simulations. On the other hand, Bayesian designs often make it easy to communicate results, incorporate multiple endpoints and achieve efficiency gains by using e.g., the predictive probability for interim decision making. Regardless of the choice of analysis method and the associated philosophical differences in the paradigms, there is an understanding that, among others, frequentist operating characteristics such as power and type 1 error are important to evaluate the proposed design. Ultimately, both Bayesian and frequentist adaptive designs aim to and should be judged by their ability to produce better and more efficient clinical trials without compromising their statistical integrity. In this session, we will bring together experts in the design of both Bayesian and frequentist adaptive trials, as well as a senior European regulator to learn more about recent methodological advances, regulatory considerations, and practical experiences when designing and assessing these trial designs.

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