IMPACT-AFib (IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation) is a nationwide pragmatic clinical trial launched in 2017 by collaborators including CTTI. IMPACT-AFib is the first trial conducted under FDA-Catalyst, which incorporates the infrastructure of the FDA’s Sentinel System and enables direct contact with health plan members and providers. To help facilitate large-scale interventional research more efficiently, the collaborators followed CTTI’s recommendations of using a single institutional review board (sIRB).
The study team shared that the use of an sIRB had many positive results, including reducing study start-up time and alleviating administrative burden and costs on sites.
The study team also shared lessons that were learned through the process of using an sIRB:
Historically, each site’s local IRB has reviewed a trial’s protocol separately in multi-center trials, which results in lengthy approval processes, duplicative work, and differing protocol or informed consent changes among sites. The use of sIRBs can improve the quality and efficiency of multi-center trials by improving oversight and streamlining the review process.
Understanding of sIRB implementation has recently become even more critical; in 2018, the NIH began to require the use of an sIRB for all multi-center trials funded by the NIH, and by 2020, all U.S. institutions involved in U.S.-based cooperative research will be required to use an sIRB.
CTTI has championed the adoption of sIRB review for nearly a decade, developing recommendations and resources to address barriers and assist in the implementation of sIRBs. CTTI is also supporting an NIH workgroup to develop a comprehensive plan for assessing the NIH’s new sIRB policy.
Learn more about the IMPACT-AFib trial on ClinicalTrials.gov.