ISCB Course 2016

Statistical Issues in Drug Development

Budapest, 14-15 October 2016.


This course is based on Stephen Senn's well-known book Statistical Issues in Drug Development, (Wiley, 1997, second edition 2007) which has been universally recognised as a comprehensive, thought-provoking and readable guide. No punches are pulled and important issues will be frankly discussed whether they concern matters on which there is general consensus or those that attract controversy.

Mathematical detail will be avoided but the value of statistics as a form of advanced common sense and a guide to rational decision-making will be stressed. The emphasis will be on practical philosophy rather than abstract algebra.

Day one provides an overview of statistics in drug development from several perspectives and is suitable for all who work in drug development and have an interest in statistics. Amongst matters covered are the value of control, randomisation and blinding in clinical trials, sources of bias, including regression to the mean and some aspects of sample size determination. Day two is more technical and is aimed more specifically at statisticians, epidemiologists and others with a more quantitative background and provides perspectives on the use of baselines, measurement of outcomes, design and analysis of more complex trials and the challenges of personalised medicine.

The overall aim is to provide new slants on some familiar material as well as covering some more advanced topics, as a contribution towards improving discussion, debate and communication in drug development.


Stephen Senn has held chairs in statistics at Glasgow University and University College London but has also worked in the NHS and the pharmaceutical industry. He is head of the Competence Center for Methodology and Statistics at LIH. He is the recipient of the Bradford Hill medal of the Royal Statistical Society (2009) and the George C Challis prize for biostatistics of the University of Florida (2001).