THE CAMBRIDGE STATISTICS DISCUSSION GROUP
Tuesday 1st February 2011 7:15 for 7:45
Department of Applied Mathematics and Theoretical Physics,
Centre for Mathematical Sciences,
Cambridge, CB3 0WB
What constitutes adequate strength of evidence?
Abstract: Adequately sized randomised controlled trials represent the gold standard for testing efficacy and safety of therapies, but they are not the only means of doing so. 'One size' doesn't fit all when designing trials across very diverse therapeutic areas. Evidence-based medicine is an ideal goal but does not automatically imply large randomised controlled trials. It is unacceptable to cut corners in study designs for no good reason, or where doing so will likely lead to uninterpretable results or misleading conclusions. Arguments will be presented why randomised controls (even very small trials) might be preferable to uncontrolled studies. Arguments in favour of 'nothing to lose' from trying new experimental therapies may not be sufficient and in some cases may be completely wrong. We need to identify the situations in which the certainty and course of disease is such that we can circumvent the need for traditional randomised controlled trials, and then match those situations with cases where practical and ethical constraints strongly encourage us to do so. Published examples of 'strength of evidence' and 'grades of recommendation' scales again indicate that one size does not fit all and acceptable grades of recommendation need to be context-specific.
Speaker: Simon has spent 25 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies. He currently works for Roche as a global statistical and regulatory consultant. He is a former president of the International Society for Clinical Biostatistics; he is an associate editor of Statistics in Medicine, on the editorial board of Pharmaceutical Statistics and joint editor of the Journal of the Royal Statistical Society. 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. He is chairman of the External Advisory Panel for the Department of Statistics at Oxford University; an external examiner at the London School of Hygiene and Tropical Medicine; and an Associate on the faculty at Johns Hopkins University in Baltimore. He also serves on the West London Research Ethics Committee in London.
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