This is an extraordinary episode that takes us deep into the world of modern pharmaceutical research. Today, we are embarking on a captivating journey guided by the insightful dialogue between Elena Polverejan and me. Throughout this episode, we uncover the potential of the Estimands Framework. Join us as we delve into the origins of Estimands, …
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 …
Simulations – your most powerful study design tool Read More »
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 …
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 …
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 …
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 …
By country analyses for clinical trials and observational studies Read More »