An Introduction to the Theory and Practice of Clinical Trials


This course has its origins in one for life-scientists that I gave in the early 1990s while working as a medical statistician in Basle, Switzerland for CIBA-Geigy, an ancestor company of Novartis Around about the same time, I was asked to develop a course on medical statistics for the Diploma in Statistics run at the University of Neuchatel. I left CIBA-Geigy in 1995 and I stopped giving the course in Neuchatel in 2003, however, in the meantime (in 1997), ideas developed in both courses had appeared in book form in a monograph entitled Statistical Issues in Drug Development, now in its third edition(1). The course for life scientists, in particular, was also an inspiration for my attempt, in the book Dicing with Death (now in its second edition(2)), to explain to a lay public what it was that medical statisticians did.

The inspiration for both books was my experience in teaching on these two courses. The Neuchatel course for statisticians, who were nearly all mathematically trained, convinced me that statisticians were in danger of missing the fact that there were deep issues in the analysis and conduct of clinical trials that required them to listen to their non-statistical colleagues and think seriously ‘beyond the mathematics’. My experience working in CIBA-Geigy convinced me that we statisticians were in danger of missing fruitful collaboration with life-scientists by letting unnecessary (for our work together) algebraic or algorithmic complications distract from the discussions on difficult issues we needed to have. What I hope to achieve in this course is discuss concepts at a deep level, so that the fundamentals are understood but without (much) interference from mathematics. Some will see this as a weakness but they should be warned that I see it as a strength(3). The course will also discuss practical matters to the extent that is necessary to appreciate the constraints under which clinical trials operate.

If you are a life-scientist, I hope that the course will give you some appreciation of why statisticians think the way they do and also give you the means to challenge statisticians you work with to justify what they are doing. If you are a statistician I hope that the course will inspire you to think beyond the algebra you are used to and that the course will facilitate fruitful collaboration with non-statisticians.


1. Senn SJ. Statistical Issues in Drug Development. 3rd ed. Chichester: John Wiley & Sons; 2021.
2. Senn SJ. Dicing with Death. 2nd ed. Cambridge: Cambridge University Press; 2022.
3. Senn SJ. Mathematics: governess or handmaiden? Journal of the Royal Statistical Society Series D-The Statistician. 1998;47(2):251-9.

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