Bayesian Methods for Clinical Trials [EL037]

Detailed information about this course:

Description

The course consists of two parts.
In Part I, the general principles of setting up and conducting clinical trials will be reviewed. A focus will be on randomized clinical trials. Both general interventions as well as drug developments will be treated. The Bayesian methodology will be introduced and the use of Bayesian software (JAGS) will be exemplified. Finally, the classical (frequentist) and the Bayesian approach will be contrasted.
In Part II, several topics in clinical trials will be discussed from a Bayesian perspective. The set up, conduct and analysis of (some of) the following types of clinical trials will be exemplified (in a Bayesian manner):
• Sample size & power calculations
• Monitoring a sequential trial and multiple testing issues
• Adaptive and platform trials
• Bridging studies
• Dose finding studies
• Studies in oncology
• Pharmacodynamic and pharmacokinetic studies
• The incorporation of historical information and real world data for the analysis of orphan studies
• Meta-analyses and network meta-analyses
In this part JAGS will be again used as Bayesian software, but in addition several dedicated R packages.
References (selection of)
1. Lesaffre, E. and Lawson, A., Bayesian Biostatistics, 2012, John Wiley & Sons, West Sussex, UK
2. Lesaffre, E,, Baio, G. and Boulanger, B. (eds), Bayesian Methods in Pharmaceutical Research, 2020, Chapman & Hall/CRC, Boca Raton, US
3. Yang, H. and Novick, S. J., Bayesian Analysis with R for Drug Development. Concepts, Algorithms and Case Studies, 2019, CRC Taylor & Francis Group, Boca Raton, US
4. Holmgren, E.B., Theory of Drug Development, 2014, CRC Taylor & Francis Group, Boca Raton, US

Assessment

Assignment(s), Attendance