Ludwig A. Hothorn (Leibniz University Hannover, Germany)
Dr. Bernd-Wolfgang Igl (Bayer AG)
Dose-response analysis is a central part in statistical evaluation of toxicological bioassays. Two approaches are used: simultaneous testing of order-restricted multiple contrasts and regression-based modeling. The first one considers the DOSE qualitatively, i.e. as randomized factor whereas the second assumes DOSE as quantitative covariate (in bioassays commonly for grouped dose levels). Both approaches are demonstrated by means of real data examples where robustness, e.g. against downturn effects is discussed. Moreover, a new approach is explained, where DOSE is jointly considered both quali- and quantitatively.
The recent p-value controversy is discussed from the perspective of regulatory toxicology where first confidence intervals for specific selected effect sizes are recommended. Secondly, the inclusion of individual data points within or without a prediction interval is proposed as an alternative to common-used null-hypothesis significance tests. The prediction intervals are defined for any single future value of a group with sample size n_i using the controls of multiple historical bioassays. The within- and between assay variance is considered by a mixed effect model.
Finally, the question will be discussed why the proof of safety („be safe in negative results“) is not widely used in routine up to now.
The “third main set” of statistics is: software must be available. And therefore all methods are demonstrated using //R-//CRAN packages.
This webinar will take place from 14:00 - 15:00 and is free to attend.
Registration has now closed.
PSI EIWG Webinar: PIONEERing estimands in Clinical Research (Session 2)
Bringing estimands to life through a real case study. Members of the estimands Implementation Working Group (EIWG) will describe the background and study objectives, intercurrent events of interest and chosen estimands in the PIONEER study.
Our annual PSI Medical Statistics Careers Event, will be held online using the Career Fair Plus app on Wednesday 3rd March 2021. The event will include a live online panel discussion and a virtual exhibition session.
Discover your extraordinary potential by working as a Covance AD, Biostatistics / Senior Principal Biostatistician. You will consult in the design of complex and innovative studies & clinical trial programs as well as Leading DMC/DSMB processes.
By joining our company, in this role you will apply your skills and experience in support of developing scientifically based arguments aiming to provide fair accessibility to our company’s drugs and vaccines making a real difference in patient’s lives.
Senior Principal / Principal Biostatistician (Oncology) – FSP
Join our team as a Covance FSP Senior Principal or Principal Biostatistician. You will be assigned to one Sponsor working on Phase I and II oncology studies. Previous Lead experience essential. Office or home-based anywhere in Europe or South Africa.