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Conducting Multicenter Clinical Trials: New Recommendations and Tool for Research

A collaborative research team established by the Clinical Trials Transformation Initiative (CTTI) created a new tool and recommendations to improve the efficiency and quality of multi-center clinical trials.

That tool and their recommendations, included in the article "Using Central IRB's for Multicenter Clinical Trials in the United States", are published in the January 30, 2013 issue of the journal PLOS ONE http://dx.plos.org/10.1371/journal.pone.0054999.

Multi-center clinical trials are conducted to provide high-quality, statistically sound evidence to answer medical questions.  Typically, each participating center submits the study protocol to its individual institutional review board (IRB). The process of multiple reviews can lead to significant study delays; furthermore, patients may be treated differently at different sites as a result, leading to confusion. Read more...

SPIRIT 2013 protocol checklist released

An international group has produced comprehensive protocol guidelines, called SPIRIT 2013, or Standard Protocol Items: Recommendations for Interventional Trials, which were recently published in Annals of Internal Medicine. SPIRIT 2013 describes 33 items that should be included in a clinical trial protocol, which is the written plan for a clinical trial. A variety of stakeholders including trial investigators, physicians, statisticians, medical journal editors, and others have worked together since 2007 on the project. The group has also published a paper in BMJ that explains each item on the checklist and offers detailed examples.  Read more...

Funding and other support

 

CTTI receives financial and in-kind support from many groups committed to improving clinical trials. Member organizations pay an annual fee which supports CTTI infrastructure expenses and projects.  The Executive Committee oversees the use of these funds.  In addition, individuals from many member organizations, and some non-member organizations, contribute time and other resources to make CTTI projects successful.  The sources of support for each project can be found on the respective project pages of the website.

Duke University, as the host of CTTI, has also received a cooperative agreement from the U.S. Food and Drug Administration (grant U19 FD003800) which provides some support for all current projects.