Delays during IRB review are a growing concern in the trials sector according to Christine Grady of the US National Institutes of Health’s (NIH) department of Bioethics.
Institutional review boards (IRB) are at the heart of the US clinical research sector’s patient protection efforts and are intended to provide an independent appraisal of data, free of the commercial pressures that weigh on drugmakers.
However, as Dr Grady told Outsourcing-pharma, the growing complexity of their work is starting to become a bottle neck that is causing some in the trial industry to question the overall efficacy of the IRB approach.
She explained that: “[Although] significant resources and efforts are directed towards IRBs…some investigators and others express frustration with the time it takes for IRB approval and the stipulations that IRBs require.”
Grady also said there is a need for research into IRB efficacy, explaining that: “Any evidence-based conclusion about IRB effectiveness could help ensure or improve effectiveness and could guide efforts to make IRBs more efficient without negatively impacting effectiveness.”
This latter point touches on concerns Grady raised in the current issue of the American Medical Association (JAMA), when she said that “no published study of I which I am aware has evaluated the effectiveness of IRBs.”
In the JAMA article she highlights the increasing number of multisite clinical trials and growing regulatory demands as having a significant impact on IRB efficiency.
Grady concludes that “serious efforts” to address these concerns are required, suggesting that greater degree of regulatory guidance coupled with a broader role for accrediting bodies are critical steps in the process.