IMPACT-AFib Shares Successes and Lessons Learned from Use of Single IRB

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:

• In a multi-center trial, each site has unique requirements, which must be taken into account by study leadership when identifying an sIRB that all sites will find acceptable. Selecting an sIRB that has national experience and is accustomed to dealing with different regulations across states is helpful. In addition, choosing an sIRB that many or all sites have used in the past expedites reliance agreements required between each site and the sIRB.
• Certain approaches can increase the efficiency of the sIRB approval process and reduce administrative burden for sites. For example, the team behind IMPACT-AFib expedited the process by submitting the initial protocol application to the sIRB that applied to all five sites. They then provided each site a template for the site submissions, noting items that might need to be adjusted according to site-specific considerations.
• Specific considerations around trial design, such as pragmatic studies leveraging claims data, should be taken into account when submitting to an sIRB. For example, sites for this study are virtual – with patient contact via mailings from their health plans – rather than contacting potential participants in-person at traditional clinical trial sites such as clinics or hospitals.
• Using an sIRB expedites the amendment process because only one submission is required, which is reviewed and approved for all sites.

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.