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Multicenter RCT
Overview
| Definition
of a Multicenter RCT
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A multicenter
RCT can be defined as a formally constituted collaborative
effort involving at least two non-affiliated institutions--clinical
research centers, hospitals, medical or dental schools,
etc-who each recruit, and enroll subjects in a clinical
trial using consensually agreed upon protocols and then
following up cohorts of patients with common outcome measures.
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The number of multicenter
RCTs has increased dramatically in the past decade, many funded
by NIH and many funded in whole or in part by the biomedical industry,
especially pharmaceutical manufacturers. However, there have been
virtually no true multicenter RCTs conducted investigating TMD,
despite the already alluded to plethora of clinical research in
the field.
The major reason for
conducting multicenter trials is to recruit and enroll adequate
numbers of patients to allow a realistic test of experimental
hypotheses. This is especially true when investigating treatments
for more rarely occurring conditions; however, even with more
prevalent disorders, large trials provide the most secure scientific
data, all other things being equal; large trials mean many participants,
which, in turn means involving many clinical centers.
Prevalence estimates
are low for some TMD subtypes, of the order of 1-8% of TMD cases,
for many forms of TMD involving disk disorders or degenerative
conditions of the TMJ as the sole disorder. RCTs requiring hundreds
of participants cannot be accomplished at a single center, and
an important reason our knowledge of TMD remains limited in several
spheres has been the lack of effort to mount multicenter trials
that can accumulate sufficient sample sizes for experimental hypothesis
testing.
Two additional related
reasons for supporting multicenter trials are:
- The opportunity
afforded to investigate, with adequate sample sizes, the effect
of a planned intervention on more than one target population,
distinguished by ethnicity, geography, psychosocial or lifestyle
levels of function, and/or socioeconomic status. For example,
are all ethnic groups equally affected by the experimental treatment;
do rural and urban centers yield comparable results, etc.
- Multicenter trials
afford the opportunity to investigate multiple treatments in
the case where each clinical site is assured of securing a sample
size large enough to evaluate one type of treatment, but unable
to adequately investigate two or more treatment interventions.
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