Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=26092476
&cmd=llinks): Failed to open stream: HTTP request failed! HTTP/1.1 429 Too Many Requests
in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 215
Estimating the sample size for a pilot randomised trial to minimise the overall
trial sample size for the external pilot and main trial for a continuous outcome
variable
#MMPMID26092476
Whitehead AL
; Julious SA
; Cooper CL
; Campbell MJ
Stat Methods Med Res
2016[Jun]; 25
(3
): 1057-73
PMID26092476
show ga
Sample size justification is an important consideration when planning a clinical
trial, not only for the main trial but also for any preliminary pilot trial. When
the outcome is a continuous variable, the sample size calculation requires an
accurate estimate of the standard deviation of the outcome measure. A pilot trial
can be used to get an estimate of the standard deviation, which could then be
used to anticipate what may be observed in the main trial. However, an important
consideration is that pilot trials often estimate the standard deviation
parameter imprecisely. This paper looks at how we can choose an external pilot
trial sample size in order to minimise the sample size of the overall clinical
trial programme, that is, the pilot and the main trial together. We produce a
method of calculating the optimal solution to the required pilot trial sample
size when the standardised effect size for the main trial is known. However, as
it may not be possible to know the standardised effect size to be used prior to
the pilot trial, approximate rules are also presented. For a main trial designed
with 90% power and two-sided 5% significance, we recommend pilot trial sample
sizes per treatment arm of 75, 25, 15 and 10 for standardised effect sizes that
are extra small (?0.1), small (0.2), medium (0.5) or large (0.8), respectively.
|*Pilot Projects
[MESH]
|Humans
[MESH]
|Outcome Assessment, Health Care
[MESH]
|Randomized Controlled Trials as Topic/*methods
[MESH]