Benefits of Utilizing a Central IRB for Multi-site Clinical Trials

The Food and Drug Administration (FDA), the Office of Human Research Protections (OHRP), and the Department of Health and Human Services (DHHS) each support the use of a central institutional review board (IRB) to improve the efficiency of conducting multicenter clinical trials in the United States.¹

A centralized review process involves an agreement under which more than one site relies in whole or in part on the review of an IRB other than the local IRB affiliated with the individual research site.²

A central IRB, as opposed to a local IRB, exists to monitor research involving human subjects for all sites involved in a research trial. Central IRBs have the ability to operate in various capacities: for an institution exclusively, on the federal level, private operations, or even as an independent entity.³

Utilizing a central IRB provides a more consistent pathway for overall patient protection within a trial. Because this type of IRB collects the clinical trial information from all active sites, it is able to detect safety problems quickly and easily, which is not only helpful in further continuing the trial, but for all future pipeline studies for the same investigational product.⁴

In a multicenter clinical trial, it can become a very costly and time-consuming scenario if each institution is required to submit to its local IRB as per institutional guidelines. As a result, costly delays may follow delay the initiation of crucial study-related activities. Institutions have multiple studies in process at the same time, and being required to submit to both a local IRB and a central IRB in every aspect of study execution unnecessarily duplicates efforts, increases expenditures, and delays clinical trial conduct.⁴

Utilizing the centralized review process for multicenter trials saves time and expenditures, reduces further delays in enrollment, and reduces the workload of the institutional IRB. Thus, many institutions use their own local IRB specifically for internally funded, investigator-initiated clinical trials, but opt for central IRB services for externally funded clinical trials.⁴

Additionally, a central IRB typically allows for better costs savings as fewer regulatory submissions are needed in comparison to using numerous local IRBs. As a result, a central IRB provides a trial with consistent, high quality, and efficient review.³

Utilizing the centralized IRB review process for multicenter trials can save time and expenditures, reduce further delays in enrollment, and reduce the workload of the institutional IRB. Thus, many institutions use their own local IRB specifically for internally funded, investigator-initiated clinical trials, but opt for central IRB services for externally funded clinical trials.

Summary

Because the goal of the centralized process is to increase efficiency and decrease duplicative efforts that do not contribute to meaningful human subject protection, it will usually be preferable that a central IRB take responsibility for all aspects of IRB review at each site participating in a multicenter trial.²

There are many advantages of working with a central IRB opposed to relegating sites to use a local IRB. From the perspective of the sponsor, simplifying the review process helps streamline the regulatory effort required to conduct all trial-related activity and should not be burdensome to investigators and research teams.³

References

1. Flynn, K.E., Hahn, C.L., Kramer, J.M., Check, D.K., Dombek, C.B., Bang, S., Perlmutter, P., Khin-Maung-Gyi, F.A., & Weinfurt, K.P. (2013) Using Central IRBs for Multicenter Clinical Trials in the United States. PLoS ONE 8(1): e54999. doi:10.1371/journal.pone.0054999
2. US Food and Drug Administration. (2020). Using a Centralized IRB Review Process in Multicenter Clinical Trials. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/using-centralized-irb-review-process-multicenter-clinical-trials#_Toc128900328
3. The Advantages of Using a Central IRB. https://trialrunners.com/the-advantages-of-using-a-central-irb/
4. Central IRB vs. Institutional IRB-Advantages and Disadvantages for Multicenter Trials. https://acrpnet.org/2018/04/17/central-irb-vs-institutional-irb-advantages-disadvantages-multicenter-trials/

Jenna Brager, PhD, RN, MS, is the director of regulatory affairs at MyMD Pharmaceuticals^®. Prior to joining MyMD, Dr. Brager served as the Director of Clinical Research for LifeBridge Health and was a clinical investigator at Johns Hopkins Hospital. Dr. Brager received her B.S. in Nursing from the University of North Florida, graduating cum laude and received her Ph.D. from the Johns Hopkins University School of Nursing.

Dr. Brager welcomes comments, questions, and requests for future blog topics. Please email [email protected].

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