Building Coalitions for Industry Change: A Collective Approach
This chapter discusses the significance of forming a collaborative coalition among various companies to implement effective change management in the industry. It focuses on enhancing the guidelines for estimating adverse events in clinical trials through collective advocacy and cooperation, aimed at improving accuracy and accountability despite challenges from existing systems.
✔ How differing follow-up times and censoring bias AE results.
✔ The role of the Aalen–Johansen estimator and why it should be standard practice.
✔ What the SAVVY collaboration achieved by uniting pharma, academia, and regulators.
✔ Real-world examples of how safety analyses can dramatically change the interpretation of treatment risk.
✔ Lessons on collaboration, methodology, and change management in the pharma industry.
Why You Should Listen:
Adverse events are a critical part of any trial, yet they’re often analyzed using simplistic methods that can mislead decision-makers. This episode will help you:
Gain insights you can apply immediately to your own projects to improve the accuracy and credibility of your analyses.
Understand the hidden biases in traditional AE analysis.
Learn how to align safety and efficacy assessments for a fairer benefit–risk evaluation.
Discover the power of collaboration between pharma, academia, and regulators through the SAVVY project.
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🔗 My New Book: How to Be an Effective Statistician - Volume 1– It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine.
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