Abstract
Clinical studies are undertaken in order to reach some conclusion about a treatment regime, and it is generally intended that this conclusion should be widely applicable — at least, to a larger group of patients than that studied in the trial itself. The patients recruited into the study therefore constitute just a sample of all of the patients to whom the investigational treatment regime might eventually be applied. This raises two questions: firstly, how can this sample be selected so that it is in some sense representative of the larger group of patients, and secondly, how can the data from the sample be analysed in a way which will yield conclusions that might validly be applied to the larger group of patients?
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Further reading
Brunier, H. and Whitehead, J. (1993). PEST — Planning and Evaluation of Sequential Trials — Operating Manual.
Machin, D. and Campbell, M. J. (1993). Statistical tables for the design of clinical trials, 2nd ed. Oxford: Blackwell.
Pocock, S.J. (1983). Clinical trials: a practical approach. Chichester: John Wiley and Sons.
Whitehead, J. (1992). The design and analysis of sequential clinical trials. London: Ellis Horwood.
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© 1995 Springer Science+Business Media Dordrecht
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Cohen, A., Posner, J. (1995). Study design. In: Cohen, A., Posner, J. (eds) A Guide to Clinical Drug Research. Springer, Dordrecht. https://doi.org/10.1007/978-94-015-8463-0_7
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DOI: https://doi.org/10.1007/978-94-015-8463-0_7
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-015-8465-4
Online ISBN: 978-94-015-8463-0
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