Seminars

The role of statisticians in biomedical applications has traditionally
focused on assessment of therapeutic efficacy.  The statistical
literature is replete with work on clinical trial designs, sample size
determination, analytical methods, control of bias, interim monitoring of results, and many other topics, but very few statisticians have given attention to the messy and difficult problems of identifying and evaluating important safety issues, especially outside the clinical trials environment.  Given all the attention to and concern about the safety of pharmaceutical (and medical device) products over the past decade, it is essential that more statisticians to take up the challenge of methodological research aimed at  identifying risks of these products in a reliable and timely way.