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A METHOD FOR DETERMINING THE SIZE OF INTERNAL PILOT STUDIES

✍ Scribed by LEIV SANDVIK; JAN ERIKSSEN; PETTER MOWINCKEL; EINAR ANDREAS RØDLAND

Publisher
John Wiley and Sons
Year
1996
Tongue
English
Weight
266 KB
Volume
15
Category
Article
ISSN
0277-6715

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✦ Synopsis

The assessment of sample size in clinical trials comparing population means requires a variance estimate of the main efficacy variable. When this variance estimate has a low precision, it may be appropriate to use the data from the first patients entered in the trial ('internal pilot study') to estimate the sample size. We suggest a method for determining the size of internal pilot studies, which aims at ensuring that this size is as large as possible, but not larger than 'the optimal size' of the planned study. Advantages and limitations of the method are discussed.

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