The Community Forum creates a space for the PHUSE Community to unite and discuss industry topics of interest in an informal setting. Disqus provides the team with a platform to host offline discussions and continue sharing information. |
The Role of the Statistician and Statistical Programmer in Real-World Data Analysis Use of real-world data in regulatory submissions is growing. Real-world data provides unique insights which can be used for informed decision-making, resulting in faster drug approval. However, the nature of real-world data is quite different from that of clinical trial data. While the latter can be controlled at all stages, from collecting to reporting, this is not the case for real-world data. This imposes many challenges including pre-study alignment with regulatory agencies regarding validity of the data used. How does this affect the roles and corresponding responsibilities of various cross-functional clinical team members? This meeting will start with a 30-minute presentation focused on the changes necessary to use real-world data followed by a forum discussion on how this affects the role of the statistical programmer and the statistician. Date: 6 July 2022 Time: 15:00 (BST)/10:00 EST |