clinical trial

Simulations – your most powerful study design tool

Innovation / By / 2023-06-06

When it comes to clinical trial design, there are many challenges to overcome, including recruitment, protocol design, and data analysis, among others. Fortunately, simulations can provide a solution to some of those challenges. Simulations allow us to test the influence of assumptions, optimize designs, and understand probabilities of success before running the actual experiment. Together …

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Bayesian approaches in early clinical research

Innovation / By / 2023-04-05

What knowledge gaps exist regarding the implementation of these new analytical techniques, and how can statisticians and data scientists bridge them to maximize effectiveness of clinical research? Despite the promises of Bayesian approaches, the lack of expert training, software tools, and computational resources has made their adoption slow. Statisticians and data scientists should invest in …

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Single arm studies

HTA, Innovation / By / 2023-02-28

Why are companies often running single arm studies in development?  What are the potential drawbacks and why is it not a binary choice between full comparative study and single arm trial? What are solutions in between to find a balance between feasibility and rigour? Single arm studies are a popular method for collecting data despite …

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The recent Alzheimer story – an absolute low for the industry and especially for statisticians

Innovation, Knowledge / By / 2023-02-02

End of last year, a congressional report about the approval of an Alzheimer drug by the FDA was published. It critiques both the FDA and the sponsor company Biogen. Reuters and many other major news organisations reported about it. Today, I interviewed Anja Schiel about this topic. We talked about the background of Alzheimer and …

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By country analyses for clinical trials and observational studies

Excellence, Innovation, Knowledge / By / 2022-11-21

How could differences between countries affect the elements that are included in statistical research? How could studies with such a diverse sample from different countries be managed to create a more dependable reference for statistical studies? How do differences of the quality of care that the target population receives impact studies? As statisticians, we need …

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