The clinical research environment stands on the cusp of a dramatic change. 
 
Anticipated FDA regulation mandating multisite trials to use a single, centralized institutional review board (sIRB) – expected by May 2025 – will be a stark departure from a decentralized model using many different local IRBs for a single trial.  
 
The sIRB mandate will transfer power to select the IRB from sites to sponsors, as sponsors will likely have final say over IRB-of-record selection. It also affords sponsors greater leverage to control study timelines. For example, when institutions no longer have the option to retain local IRB oversight for multisite trials, and all trial sites use the same sIRB for a given trial, the administrative redundancies associated with multiple local IRB review that often extend study timelines will decrease significantly. One sIRB of record for all sites not only reduces administrative burden but also eliminates disparate feedback from multiple local IRBs to promote consistent study conduct and provide uniform information to patients across sites. 
 
At a time when both the number and complexity of clinical trials have ballooned – with a 6% increase in the average number of trial endpoints since 2003 – the centralized sIRB approach helps trim the fat by increasing speed-to-approval and eliminating duplicative costs. In one multisite trial of an influenza vaccine, the NIH compared the sIRB model to a local IRB approach and found the mean time to approval was “substantially faster,” 81 versus 121 days. Time to first enrollment was also faster (126 vs. 149 days, and faster compared with published averages of 169 days). Getting a product approved more than a month sooner using sIRB can equate to millions of dollars saved.
 
But that is just the beginning. The anticipated sIRB mandate also affords clinical trial sponsors with an unprecedented opportunity to reassess trial site partners. 
 
Soul-Searching: Reassess Sites to Drive Consistency Across the Enterprise
Since the proposed FDA rule will transfer more leverage to sponsors, the changeover presents an opportunity for sponsors to re-assess commonly used trial sites and analyze their performance based on key and standardized indicators (such as study startup time, enrollment diversity, and participant retention rates) versus selecting sites based on perceived reputation of key opinion leaders and other less-quantifiable criteria.
 
Using consistent metrics, sponsors can make objective comparisons of sites – not just relying on institutional reputation or name recognition – to understand which sites are contributing best to efficient and compliant clinical research. For example, sponsors that routinely select the same cancer center because that’s what they’ve always done could inadvertently be causing unnecessary administrative delays. A well-recognized cancer center may still be the right choice, but now sponsors have an opportunity to objectively re-evaluate that choice based on empirical evidence.
  
“Organizations naturally tend to work with the same, familiar trial sites that they have had historically positive experiences with over time,” explained Aaron Sanford, senior director, study start up at Linical, a global CRO for full-service drug development. “However, working with the ‘same old same old’ could cause companies to inadvertently miss out on opportunities to improve trial operational performance, patient recruitment success and speed, patient population representation (diversity), and efficiency.” 
 
Review by a single IRB will allow sponsors and CROs to evaluate study activation timelines on a level playing field absent disparate performance from the local IRB and reveal sites that are faster or more efficient. As the industry continues to evolve, sites with longer study activation timelines even when using the more efficient sIRB model will face increased scrutiny and may drop off sponsors’ preferred site list, while those activating studies quickly and consistently could be rewarded with early opportunities to work on new studies.
 
By disentangling the IRB review responsibilities from pure site-startup responsibilities, sponsors have a chance to do some internal soul-searching on sites – especially institutional sites such as academic medical centers. Don’t just keep using Acme University, for instance, because they employ Dr. Smith Genius. This is a big opportunity for sponsors to improve study efficiency. 
 
Top 5 Site Characteristics to Look For 
Advarra’s latest benchmarking data shows the characteristics of the top 10 most efficient and effective sites from an sIRB review perspective, offering sponsors and CROs a data-driven performance checklist to guide re-evaluation of sites. For example, institutions that require an informed consent form sign-off and institutions with two-step ceding processes have longer turnaround times. The most efficient sites tend to have no additional administrative processing requirements other than some very basic needs.
 
Most common characteristics of efficient sites:

• They have already disentangled local institution administrative reviews from IRB review, ensuring those local activities happen before, or in parallel, with IRB review, so the process is not delayed.
• If they require local review/approvals before submitting to the sIRB, they have simple processes to reduce the burden on research teams.
• They don’t wordsmith the ICF and generally accept the study-level template language agreed to between the sponsor and the sIRB.
• They require the sIRB to receive a coversheet indicating the study is cleared by the local administration, and this communication is straightforward for the sIRB to process.
• Their local system integrates with the sIRB’s technology, making status tracking and documentation simpler and less error prone.

Common characteristics of less efficient sites:

• Their IRB or HRPP office conducts a “shadow IRB review” on top of the sIRB review. The sIRB mandate will not prohibit this practice of doing a duplicate review, however shadow reviews are not binding and can add unnecessary burden.
• They pause the sIRB review process (once or multiple times) to accommodate internal/local administrative review committee activities (e.g., feasibility committees, department signoffs, pharmacy committee, scientific review committee, etc.) rather than moving in parallel or eliminating committees altogether where possible.
• Their budget and contract negotiations are long (i.e., Medicare coverage analysis can take four weeks or longer per study), delaying submission to sIRB or delivery of approval documents. 
• They require an IRB reliance agreement per study (rather than having a global one with the sIRB), which often gets held up in legal review.
• They submit to the sIRB for review with institution-specific consent language which has not yet been approved by the sponsor (so these changes need approval by the sponsor before IRB can finalize/release documents). This practice results in multiple rounds of back and forth between sponsor, sIRB, and institution on language which could have been negotiated directly between the site and sponsor prior to sIRB review.

Turning Lemons into Lemonade
Sponsors’ current view into institutional processes is not always clear, but the upcoming sIRB mandate should create newfound transparency. Like separating an egg yolk from its white, the sIRB mandate will essentially allow sponsors to detach traditional IRB review processes from site activation processes where these practices have been historically blended and making it nearly impossible to distinguish between the two. As a result, sponsors have struggled to accurately evaluate them each on their own. 
 
This is about to change. Even as the transition to an sIRB model will bring its own set of challenges, the change is good. Sponsors should seize the opportunity to turn change management lemons into lemonade and improve clinical trial efficiency across their enterprise portfolio.