07.11.2018 – 08.11.2018
You do not necessarily want to become a Biostatistician but you always wanted to understand a bit better the concepts and principles of biostatistics in clinical trials. If this is true, this workshop is the right place for you – and biostatistics is definitely more than randomization and sample size calculation…
This workshop will give an overview on statistically relevant aspects of data structures, principles of descriptive statistics, basic concepts of hypothesis testing, sample size estimation and statistical implications of study designs in Phase I trials. That is, you will learn more about statistical aspects of typical Phase I trials like bioequivalence trials including adaptive design and replicate administrations for highly variable drugs but also First in Human and other dose escalation trials. Thereby you will get a better understanding of the contribution of biostatistics to trial designs and evaluation of clinical data.
This workshop has been developed for investigators, project leaders and other relevantly involved functions in pharmaceutical industry, CROs and hospitals, who are responsible for Clinical Pharmacology trials. But also for scientists at regulatory authorities, ethics committees or universities being involved in early clinical trials this workshop will provide excellent insight into biostatistics and hands-on experience. Practical examples will perfectly complete the scientific presentations. The knowledge and understanding obtained in this course will help you to facilitate the communication with your Biostatistical colleagues, in the generation of scientifically sound trial concepts and enable you to evaluate and interpret the obtained clinical data in a professional way.