Relationships in any business are a vital part of establishing success in the field of ophthalmic clinical trials. Among those relationships, a CRO must have a working arrangement with an Institutional Review Board, or IRB. An IRB, the team or committee that is tasked with the responsibility of enacting and ensuring the safety of patients participating in a clinical trial, have broad responsibilities that include protocol study, documentation review, and informed consent participation to ensure no conflict of interest associated with the trial. 1 This responsibility, in the field of clinical trials, and of course the field of ophthalmology, has been streamlined in the form of utilizing a central IRB. No matter the size of the study, the sponsor must gain approval from an IRB before they can start up a study. 1
Clinical research in the current configuration have certain regulations to oversee procedure and were implemented back in a time when a single institution were maintaining FDA compliance and patient safety via local IRBs, a network of Institutional Review Boards that are adjacent to the appropriate site. Industry trends when the regulations were put in place dictate that local IRBs were utilized for studies. Using multiple local IRBs can be ineffectual and not efficient so that is where the central IRB enters the picture. 2
A Central IRB, opposed to a Local IRB, exists to monitor research involving human subjects for all sites involved in a research study. Central IRBs operate for an institution exclusively, on the federal level, private operations, or even as an independent entity. 1 In addition, large university and hospitals are actually required to use local IRBs but that challenge is roundly understood in the industry. There are many advantages to utilizing a central IRB over using a network of local IRBs.
As noted in the graph above, not only does a central IRB provide a more centralized, cohesive avenue for streamlined patient protection with a study, but a central IRB has the distinct advantage of saving costs opposed to utilizing numerous local IRBs. The use of a central IRB, especially for a multi-site study, is a cost effective solution to the troubles associated with using local IRBs. A central IRB provides a study with consistent, high quality, efficient review. Sponsor and sites work with a central IRB to improve subject safety and the quality of the research. 2
When approaching a multi-site clinical trial, the advantages of working with a central IRB opposed to relegating sites to use a local IRB far outweigh in favor of the former. From the perspective of the sponsor, simplifying the most important aspects of clinical research will pay off in the long run if they want to get a drug approved.
1. What's a Central IRB? http://altarum.org/health-policy-blog/what%E2%80%99s-a-central-irb
2. Benefits of Working With a Central IRB. http://www.sairb.com/IRBForms/Benefits_of_Working_with_a_Central_IRB.pdf