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European Biopharmaceutical Review

Bay of Promise

HOW ARE CLINICAL TRIAL DATA ANALYSED?

Clinical trial data are often analysed using ‘frequentist’ methodology; that is, p-values (and confidence intervals) are calculated and then used as the principal means of assessing and reporting results. This methodology is based on the idea that if you repeat the same experiment many times, then your 95 per cent confidence interval describes the range of results that you will see in 95 out of 100 repetitions.

An alternative approach is to use Bayesian methods, where data can be continually used to update the probability that a scientific hypothesis may be true. As data accumulates, the degree of belief in the hypothesis changes. With increasing amounts of data, the probability often becomes very high or very low. The term ‘Bayesian’ comes from the use of ‘Bayes’ theorem’ in the inference process, which was derived from the work of the Reverend Thomas Bayes.


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Alan Phillips is Senior Director Biostatistics, Europe and Rest of the World, at ICON Clinical Research. Prior to joining ICON, Alan worked at Wyeth Pharmaceuticals. His last position within Wyeth was Senior Director – Biostatistics at Wyeth Research’s worldwide headquarters in the US. Alan’s statistical interests include biostatistical guidelines for regulatory submissions, clinical trials and adaptive designs. He was a member of PSI’s (Statisticians in the Pharmaceutical Industry) main committee from 1993 to 1996, the scientific sub-committee from 1995 to 1996 and the training sub-committee from 1991 to 1994. He has been a member of the PSI Regulatory Sub-Commitee since 1988.
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