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Functions and organization of coordinating centers for multicenter studies. / Blumenstein, Brent A.; James, Kenneth E.; Lind, Bonnie K. et al.In: Controlled Clinical Trials, Vol. 16, No. 2 SUPPL., 04.1995, p. 4-29.
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TY - JOUR
T1 - Functions and organization of coordinating centers for multicenter studies
AU - Blumenstein, Brent A.
AU - James, Kenneth E.
AU - Lind, Bonnie K.
AU - Mitchell, Herman E.
N1 - Funding Information: Examples of coordinating centers that manage multiple studies in multiple diseases include the pharmaceutical industry clinical study departments, the commercial clinical research organizations that specialize in managing multicenter studies, university-based clinical research units, the United States Veteran Affairs Cooperative Studies Program (VACSP) coordinating centers, and the Medical Research Council (MRC) based in the United Kingdom. Many of the considerations discussed in the previous section apply, with the added complexity of multiple diseases. Unlike the relatively homogeneous cooperative group field sites, different field sites may be engaged in each study. Coordination of multiple studies of multiple diseases increases the need for coordinating center personnel familiar with different diseases, multiplies the number of unique data collection forms, expands the number and type of quality assurance mechanisms required, and increases the multiplicity and complexity of computer software and systems developed by coordinating center personnel. The degree to which commonalities between studies are recognized and exploited governs the simplicity of organization and efficiency of operations that can be achieved. Funding Information: Coordinating centers for multicenter studies typically follow several models. The most recognizable model is an organization created specifically to coordinate a single clinical trial, e.g., one sponsored by the United States National Institutes of Health (NIH), such as the Hypertension Detection and Follow-up Program (HDFP) [l]o r the Multiple Risk Factor Intervention Trial (MRFIT) . In the pharmaceutical industry, coordination functions for multicenter studies usually are dispersed within the larger enterprise; the coordinating center may not be a readily identifiable entity because there are separate units for biostatistics, programming, and data management, each making a contribution to the coordination of multiple studies. Coordinating centers for large cooperative research groups, such as the cancer and AIDS groups, follow yet another model. Coordinating centers engaged in multiple studies often are based in universities or government agencies or are housed in commercial clinical research organizations (CROs).
PY - 1995/4
Y1 - 1995/4
UR - http://www.scopus.com/inward/record.url?scp=0028903649&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0028903649&partnerID=8YFLogxK
U2 - 10.1016/0197-2456(95)00092-U
DO - 10.1016/0197-2456(95)00092-U
M3 - Article
C2 - 7789143
AN - SCOPUS:0028903649
VL - 16
SP - 4
EP - 29
JO - Controlled Clinical Trials
JF - Controlled Clinical Trials
SN - 0197-2456
IS - 2 SUPPL.