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 »
Interview with Josephine Wolfram What is Real World Evidence (RWE) about? What is the perspective of the FDA on real world data and evidence? The FDA guidance contains 3 big topics – what are these? RWE is one of the most hot topics in the industry and the way the FDA views this data source …
Interview with Gaëlle Saint-Hilary What are the benefits of including external data in the design and analysis of clinical studies?How does the meta-analytic predictive model (MAP) work? Boosting clinical trial data with external data belongs to the very hot topics at the moment. Every conference includes a session about it and many webinars present about …
How to integrate external data into your clinical studies: from theory to application Read More »