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| home > epc > spring 2003 > alternative statistical methods for conducting clinical trials - a personal regulatory insight |
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European Pharmaceutical Contractor
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Recent concerns about increasing research costs and long approval times have placed a renewed emphasis on the methodological aspects and design of clinical trials. However, it should be stated that these are not the only areas for concern. Many ethical considerations, from the constant demand to reduce the amount of recruited individuals, to the controversial views on the use of placebo groups, provide a wide forum for debate. 'Alternative' clinical trial models increasingly challenge the industry and the regulators but if regulatory awareness is increasing, the active role of the ethics committees is still in question.
There are three main groups of alternative approaches: specific designs; unusual statistical techniques; and the use of surrogate endpoints. When implementing alternative trial design a couple of important factors must be considered. Firstly the development of statistical techniques can be advantageous and create opportunities.
Secondly the 'classical' approach is often, if not always, inappropriate for trials involving medicinal products designated for the regulatory status of orphan drugs (1) or medication for rare diseases, thus posing problems for trials conducted in small populations and trials in paediatrics (2). Lastly, with particular reference to the assessment of efficacy, a higher number of new medicinal products' marketing authorisations are being granted predominantly (if not solely) on the basis of clinical surrogate endpoints. This situation also requires ongoing regulatory consideration.
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