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Encyclopedia > Multicenter trial

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. In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a research study. ... Using the knowledge gained in basic and applied research to conduct research (generally with humans) in treating disease or dysfunction in a new way. ...

Contents


Competitive Enrolment

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.


Additional reading

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


External links


  Results from FactBites:
 
Multicenter trial - Wikipedia, the free encyclopedia (386 words)
A clinical trial conducted at more than one medical center or clinic.
Most large clinical trials, particularly Phase III trials, are conducted at several clinical research centers.
The benefits of multicenter trials include a larger number of participants, different geographic locations, the possibility of inclusion of a wider range of population groups, and the ability to compare results among centers, all of which increase the generalizability of the study.
NIH Guide: MULTICENTER CLINICAL TRIAL OF FOCAL GLOMERULOSCLEROSIS IN CHILDREN AND YOUNG ADULTS (5839 words)
Details of the responsibilities, relationships, and governance of a clinical trial funded under a cooperative agreement are described under the section entitled “Terms and Conditions of Award.” The total project period for applications submitted in response to this RFA is five years.
The primary outcome of this clinical trial is a clinically significant reduction or remission of proteinuria.
An organizational structure for the trial should be set forth in the application, delineating lines of authority and responsibility for dealing with anticipated problems in all general areas as well as stated willingness to follow the commonly agreed- upon protocol.
  More results at FactBites »


 

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