A multicenter research trial is a
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
that involves more than one independent medical institutions in enrolling and following trial participants.
In multicenter trials the participant institutions follow a common treatment protocol and follow the same data collection guidelines, and there is a single
coordinating center that receives, processes and analyzes study data.
Benefits
An important benefit of multicenter trials is that they permit the enrollment of a larger number of participants at a faster rate, in comparison to a single-center trial, putting to use the sources of multiple institutions.
This is crucial when the anticipated benefit from a treatment will be relatively small, or an expected outcome is likely to be uncommon, making a larger
sample size
Sample size determination or estimation is the act of choosing the number of observations or replicates to include in a statistical sample. The sample size is an important feature of any empirical study in which the goal is to make inferences abo ...
necessary. Therefore, studies on preventive measures and therapies tend to be designed as multicenter trials. In studying novel pharmaceuticals,
Phase III trials
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phase ...
, which compare the new treatment to an established one, are usually multicenter ones. In contrast, Phase I trials, which test potential toxicity of the treatment, and Phase II trials, which establish some preliminary efficacy of the tested treatment, are usually single-center trials, as they require fewer participants.
The benefits of multicenter trials also include the potential for a more heterogenous sample of participants, from different geographic locations and a wider range of population groups, treated from physicians of different backgrounds, and the ability to compare results among centers, all of which increase the generalizability of the study. In many cases, efficacy will vary significantly between population groups with different genetic, environmental, and ethnic or cultural backgrounds ("demographic" factors); multicenter trials are better at evaluating these factors, by giving the opportunity for more
subgroup analyses. Heterogeneity in the sample means that the findings will be more generalizable. On the other hand, a more heterogeneous study population generally requires a larger sample size to detect a given difference.
References
External links
ClinicalTrials.govfrom US
National Library of Medicine
The United States National Library of Medicine (NLM), operated by the United States federal government, is the world's largest medical library.
Located in Bethesda, Maryland, the NLM is an institute within the National Institutes of Health. I ...
Role of ICH GCP and Recruitment Strategies Training of Clinical Sites Staff in Successful Patient Recruitment Rates By Marithea Goberville, Ph.D.IBPA Publications 2005
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Clinical research
Clinical trials