Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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Designed to ensure the safety of clinical trial participants and an ethical approach to study design, Institutional Review Boards or IRBs play a critical role in reviewing research protocols and relevant materials. The primary challenge in designing and conducting an IRB trial is that multiple site-specific IRBs will conduct the same review-related tasks but in timeframes that may differ, as site operations and resources vary. This duplication in efforts can create unnecessary redundancy among site-related IRBs, adding time, cost and resources to achieve trial goals.
In September 2022, the U.S. Food and Drug Administration released a proposed rule, IRBs: Cooperative Research, to harmonize with the Department of Health and Human Services’ Common Rule, an existing federal policy implemented to protect participants. In the IRBs: Cooperative Research proposed rule that is currently under review, it would require the use of a single IRB for multi-site clinical trials within the U.S. to ideally help reduce the administrative burden for study teams and IRBs and allow for faster trial start-up while upholding safety standards for participants. This would parallel steps taken recently in Europe, where the EU Clinical Trial Regulation (implemented in 2022) requires a single decision on the ethical acceptability of a clinical trial application within each EU Member State.
Aiming to optimize efficiency in drug development while protecting patient safety, the proposed FDA rule may be beneficial to all key trial stakeholders, including sponsors, site teams and ultimately, patients. Let’s take a closer look at what the real-world impact could be for those involved.
Maintaining trial continuity through COVID-19, it became more apparent than ever how much site teams need support to allow staff to focus on quality patient care, while integrating trial components and technologies that help enhance patient engagement and more.
With the FDA’s current regulations encouraging the use of one IRB among multiple U.S.-based sites for joint review to avoid duplication, it is one way to help reduce site burden. This is especially true for independent investigator sites that do not have their own IRB, as they can make use of a commercial IRB, a “central IRB”, for approval of trials they conduct at their institution. Large academic institutions and hospitals typically have their own IRB (a “local IRB”) and must use their IRB for protocol review and approval at their institution. Under the new single IRB review process, both the independent Investigator sites as well as the academic institutions and hospitals would be obligated to accept the review/approval from an IRB that may not be their “usual” IRB. This may mean institutions with their own IRBs would have to accept review/approval from another institution that is designated as the sole IRB for the study.
While reducing duplicated efforts for sites and IRBs, there will be specific changes to business- as-usual processes that sponsors and sites must account for, including:
Sponsors, their CRO partners and study teams need to consider how to best address these sites and IRBs’ concerns as early as possible in the trial design phase.
In anticipating concerns and challenges to a single IRB strategy early in trial design, there are opportunities to maximize efficiency in steps for protocol review. As trials then rely on a single IRB’s review process, timelines can be accelerated and allow for sponsors and sites to begin participant enrollment activities sooner.
Though the FDA has not stated when the proposed rule may take effect, industry stakeholders should keep a close eye on what is to potentially come down the pike and how to best prepare and plan for shifting to the single IRB design. Currently, we do know the FDA is reviewing comments provided by stakeholders to determine how best to move forward with the rule. So far, there are three noted exceptions to the rule in requiring single IRB review:
As all stakeholders, including the FDA, are focused on keeping patient safety top of mind, while working to ensure much-needed treatments reach them as soon as possible, close monitoring the agency’s steps and updated guidance to help sponsors and sites optimize planning of trials involving IRB review will be a critical piece of the larger drug development puzzle.
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