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| home > epc > autumn 2004 > revolutionising sleep studies: making the most of multi-centre clinical trials |
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European Pharmaceutical Contractor
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There is an increasing trend in the field of sleep medicine to conduct clinical trials as multi-centre trials. The reason for this is that a larger number of patients with a particular diagnosis can be enrolled in a shorter timeframe, thus fulfilling the inclusion criteria required for a specific trial. This, in turn, leads to a significant reduction in time to market. However, multi-centre trials do pose certain challenges. Much effort has to be invested into site co-ordination and the implementation of harmonised standard operating procedures (SOPs) for accurate data collection and handling. This is of the highest importance because data acquired under even slightly different protocols cannot be directly compared.
The most comprehensive diagnostic system for sleep-related disturbances next to ICD-10 and DSM-IV, the International Classification of Sleep Disorders (ICSD), lists 88 distinct sleep disorders and corresponding diagnostic criteria. In most cases, each criterion requires a patient's objective evaluation in a specialised sleep laboratory (polysomnography). Consequently, all-night polysomnography, that is the simultaneous recording of biosignals during a period of several nights - which typically includes an adaptation night, a baseline night, followed by acute and chronically drug-treatment nights, as well as acute and chronically wash-out nights - is the core element in clinical trials that are devoted to the study of sleep. During multi-centre trials, care has to be taken that data recording is accomplished under exactly the same conditions each time.
The problem of harmonisation becomes even more relevant when it comes to data analysis. In sleep research, visual data analysis by human experts is still the scientific standard, although the variability due to subjective interpretation of the scoring rules, even between experienced experts, has proven to be a considerable source of inconsistency. For that reason, extensive resources need to be devoted to assuring quality in sleep-related multi-centre trials, for example the quality control of recorded biosignals.
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