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the free encyclopedia
Multicenter research trial.
A
clinical trial that's
conducted at more than one medical
center or clinic. Most large
clinical trials are conducted at
several
clinical research centers. The
benefits of multicenter trials
include a larger number of
participants, different geographic
locations, various ethnic groups
and the ability to compare results
among centers, all of which
increase the generalizability of
the study.
Competitive Enrollment
Enrolment should be
competitive. If the subject
recruitment rate is lower than
expected at one centre and higher
than expected at another, planned
allocation numbers should be
transferred from the centre with
low subject recruitment to a
centre with high recruitment where
subject inclusion is expected to
be completed earlier than planned.
This will be done to help ensure
that subject enrolment is
completed as planned.
Set up costs
The low set up costs should be
negotiated in order to enable to
sign agreements with larger number
of sites.
Expected subject recruitment
rate
Expected subject recruitment
rate should be evaluated. Subject
enrolment ends when the planned
number of subjects is reached. The
recruitment rates estimate should
be based on retrospective data
provided by the investigator(s)
from previous studies, i.e., on
the number of subjects who would
have satisfied the proposed
inclusion/exclusion criteria in
the past.
The investigator(s) should make
every effort to ensure that the
planned accrual rate is
maintained, that CRF’s are
completed promptly and completely,
and that data quality is
maintained at all times. The
investigator(s) should discuss
with the monitor any anticipated
problems with recruitment or
delays in study completion.
Number of sites for the study depends on estimated recruitment rates.
Although, without outside
assistance, the typical site may
recruit as few as one-fifth of the
patients it promised to deliver
originally. Some may recruit none,
taking their setup money and
contributing nothing more, or
recruit only one patient so that
there is no offsetting control.
