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Dr. Simon Day

Statistical and Regulatory Consultant, Clinical Trials Consulting & Training Limited

Dr. Simon Day has spent 30 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies. He now works as a statistical and regulatory consultant to pharmaceutical and biotechnology companies around the world. He is particularly well known for his work in the area of developing treatments for rare diseases.

He is a former president of the International Society for Clinical Biostatistics. He is joint editor of Statistics in Medicine, on the editorial board of Translational Sciences of Rare Diseases, and previously joint editor of the Journal of the Royal Statistical Society; he has also served on editorial boards on many other journals, including Pharmaceutical Statistics, Controlled Clinical Trials and British Journal of Clinical Pharmacology.

He is chairman of the External Advisory Panel for the Department of Statistics at Oxford University and an Associate on the faculty at Johns Hopkins University in Baltimore. He formerly served as vice-Chairman of the West London Research Ethics Committee. In 2012 he was elected a Fellow of the Society for Clinical Trials. He has published widely in statistical and medical journals, is author of one book "Dictionary for Clinical Trials" and is joint editor of the "Textbook of Clinical Trials", both published by Wiley.

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Clinical Trials and Evidence-Based Medicine in Rare Disease

This talk challenges apparently simple notions of when to do (or not to do) randomised controlled clinical trials.