Multi-center clinical trials can provide high-quality, statistically-sound evidence to answer medical questions. Earlier this year, the Clinical Trials Transformation Initiative (CTTI) launched a new tool and provided recommendations to improve the efficiency and quality of multi-center clinical trials.
Typically, each participating center submits the study protocol to its institutional review board (IRB). Thus in a multi-center trial, the same protocol is submitted to as many IRBs as there are sites. The process of multiple reviews can lead to significant study delays; furthermore, patients may be treated differently at different sites as a result.
Historically, the Food and Drug Administration (FDA), the Office of Human Research Protections (OHRP), and the Department of Health and Human Services (DHHS) have recommended using central IRBs, but many research institutions have been reluctant to do so. Part of this reluctance seems to have stemmed from confusion about the role and responsibility of the institution when a central IRB is involved. CTTI developed a guide to support communication between research institutions and central IRBs as they develop an agreement regarding roles for multi-site trials.
Jerry Menikoff, M.D., J.D., director of OHRP said, “The conduct of today’s science increasingly would benefit from the use of a single IRB to review multi-site studies. This issue was a focus of the July 2011 Advance Notice of Proposed Rulemaking, the next steps to which are now under consideration by HHS. The work by CTTI to identify major concerns about the use of this type of IRB review, and to spell out suggestions to address those concerns, could help to smooth the ongoing transition to more centralized review.”
CTTI also identified lack of experience with central IRBs as another barrier to their use. Thus, CTTI recommends that sponsors in a position to do so require the use of central IRB review for multisite trials, to allow stakeholders to gain experience that may foster greater comfort and trust with that model.
The ultimate goal of central IRBs is to benefit patients by streamlining the clinical research process and delivering effective treatments and cures.
“IRBs play a critical role in protecting clinical trial participants,” said Jeff Allen, PhD, Executive Director of Friends of Cancer Research. “However, it’s important to periodically review the processes used to ensure that research is not being inappropriately slowed. The use of central IRBs can continue to provide the necessary patient protection while streamlining the clinical research process, both of which are essential for the development of promising new therapies.”
Established by Duke University and the FDA as a public-private partnership in 2007, CTTI includes more than 60 member organizations working to identify practices that will improve the quality and efficiency of clinical trials.
The tool and their recommendations are highlighted in an article – Using Central IRB’s for Multicenter Clinical Trials in the United States – published in the January 30, 2013 issue of the journal PLOS ONE.