White Paper

How Institutions Gain Research Trial Opportunities

Source: Quorum Review
Business Meeting Presentation

When the Food and Drug Administration (FDA) first authorized a framework for independent IRBs in 1981, it enabled the development of a central institutional review board (IRB) review model for multisite studies. Independent IRBs formed first to provide ethical and regulatory oversight of unaffiliated (aka community) investigators. But in the decades since 1981, the role of independent IRBs has expanded and industry sponsors and clinical research organizations (CROs) now urge research institutions to use a central IRB of record for multisite studies rather than an institution’s internal IRB. Industry sponsors have good reasons to use research institutions as investigative sites, and industry-funded research may present opportunities to an institution’s research programs, but longer timelines at institutions often discourage sponsors and CROs.

Academic Medical Centers (AMCs) across the U.S. are attempting to win more industry-sponsored research trials, and one strategy is to partner with the multiple external IRBs that sponsors and CROs designate as central IRBs. Three case studies illustrate how and why leading institutions have made the decision to switch from reliance on just one external IRB to partnering with multiple independent IRBs.

A representative from a CRO specializing in oncology research said that she values an AMC’s facilities and depth of knowledge for her trials. “For these first-in-human studies, we always want that expertise,” she says. But the CRO representative adds that these same AMCs can slow research down when they rely on their own IRBs, “even when alternatives exist.”