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 course is aimed at clinical trial statisticians who are new to or with limited experience of machine learning. Attendees will learn about a range of topics in machine learning, including practical sessions in R.
This webinar will explore two different approaches to Correlates of Protection in vaccine development.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.
