Clinical Biostatistics & Data Analysis

Estimands and Intercurrent Events in DCT, Rescue and Switch Designs Estimands and intercurrent events play a crucial role in the success of clinical trials, particularly in areas such as ulcerative colitis. This article serves as a comprehensive guide for clinical operations, regulatory affairs, and medical affairs professionals involved in clinical research in the US, UK,…

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Communicating Estimand Choices to Sites, Investigators and Regulators In the rapidly evolving landscape of clinical trials, the selection and communication of estimands have become increasingly essential. Estimands serve as a bridge between the clinical question of interest and the statistical analysis, particularly in the context of handling intercurrent events. This comprehensive tutorial aims to guide…

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Estimands in Pediatric, Rare Disease and Long-Term Extension Trials Estimands in Pediatric, Rare Disease and Long-Term Extension Trials The clinical research landscape is evolving, especially with the increasing emphasis on patient-centered outcomes. Estimands are essential for accurately reflecting the treatment effects in clinical trials, particularly in pediatric and rare disease contexts. This guide provides a…

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Case Studies: Estimand Strategies That Clarified Trial Interpretation Case Studies: Estimand Strategies That Clarified Trial Interpretation Understanding how to formulate estimands effectively is crucial for clinical research professionals who aim to enhance trial interpretation. This article will provide a comprehensive tutorial on estimands and handling intercurrent events through real-world case studies within clinical trials. We…

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Regulatory Feedback Trends on Estimands and Intercurrent Event Handling Regulatory Feedback Trends on Estimands and Intercurrent Event Handling In recent years, regulatory authorities across the globe have emphasized the importance of understanding estimands and handling intercurrent events in clinical trials. This article serves as a comprehensive step-by-step tutorial for clinical operations, regulatory affairs, and medical…

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Programming and Data Requirements for Estimand-Based Analyses Programming and Data Requirements for Estimand-Based Analyses Introduction to Estimands in Clinical Trials The emergence of the estimand framework marks a significant evolution in the formulation and analysis of clinical trial data, particularly with the aim of aligning the statistical analysis plan with the actual clinical questions posed…

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Training Cross-Functional Teams on Estimands and Trial Design Implications The 2020 revision of the ICH E9 Guideline introduced the concept of estimands, an essential framework aimed at clarifying and improving the understanding of clinical trial objectives. The incorporation of estimands can profoundly impact clinical trial design and analysis, especially in the context of handling intercurrent…

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Integrating Estimands With QbD, CtQ and Risk-Based Monitoring In the increasingly complex landscape of clinical research, the need for a structured approach to managing clinical trials is paramount. The integration of estimands with Quality by Design (QbD), Critical to Quality (CtQ) attributes, and Risk-Based Monitoring (RBM) provides a robust strategy for ensuring accuracy in clinical…

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Common Mistakes in Estimand Definition and How to Avoid Them Common Mistakes in Estimand Definition and How to Avoid Them The definition of an estimand is a critical element in the design and analysis of clinical trials. An estimand specifies what effect of a treatment is of interest and under what conditions it is estimated….

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