What non-statistitians need to know about statistics
Stephen Senn, Prof Statistics, Univ of Glasgow, Willi Maurer, Global Head Statistical Methodology, Novartis
Stephen Senn, Prof Statistics, Univ of Glasgow,
Willi Maurer, Global Head Statistical Methodology, Novartis
If you really feel uncomfortable around statistics, Senn and Maurer made this session more understandable and enjoyable. The audience laughed a lot, this is most likely the secret to Prof Senn's success with students. The presenters discussed how statistics or biostatistics has changed in the world of clinical R&D to a position of becoming an integral player in R&D.
Also discussed was the use of Bayesian statistics especially as new tools in analysis methods to support innovative and dynamic trial design. Both speakers discussed how dynamic a tool Bayesian statistics can be, and how effectively it can be used in the conclusion section when making a decision about a drug. Prof Senn's book, Dicing with Death, is a great way to get more expertise on the subject and laugh at the same time.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
