Slow study start-ups tied to local IRB use, expert says

30-Mar-2015 - Last updated on 01-Apr-2015 at 13:19 GMT

As CROs (contract research organizations) and sponsors look to shave off time from their clinical trial start-up phase, which is where delays occur most frequently, companies may want to look away from local IRBs (institutional review boards), an expert told us.

A lot of academic sites that sponsors and CROs typically go to first for support in a clinical trial often rely on local IRBs for protocol reviews, where study start-up can take as long as four to six months, Dr Lindsay McNair, Chief Medical Officer and President of Consulting Services at WIRB-Copernicus Group (WCG), told Outsourcing-Pharma.com. She noted that in that same amount of time, other sites using independent or centralized IRBs have already completed enrollment.

And with comparable pricing, it would make sense that more research sites would have their protocol review work done by independent IRBs.

However, it may not always be that simple. According to CRO PPD, if a trial site uses a central or independent IRB and a local one exists, the site may be required to justify the decision or seek approval from the local IRB to use the other IRB.

In addition some see other benefits to using a local IRB. A survey from 2011 found that local IRBs can often provide "local knowledge" of subjects and principal investigators (PIs), and PIs may interact more effectively with local IRBs. Overall, interviewees said they were wary of centralized and independent IRBs, which they saw as “varying widely in quality,” though that perception may have changed as these IRBs have become more familiar over the years.

Other Trends

McNair told us that in addition to the trend of CROs and sponsors looking to save time, they also are interested in using fewer vendors, which plays to the advantage of WIRB-Copernicus, which brings together site identification and selection services, as well as IRB services.

“The people running studies want to work with partners rather than vendors…and bring in expertise to help with multiple parts of the studies,” McNair said.

Another trend McNair noted is that WCG is seeing a shift in terms of the type of products coming into development, noting that around 40% of all new research is in oncology. WCG offers three different IRBs related to oncology trials and they’re boards filled with experts who “understand the science, and can focus on the protocol” without asking the sponsor or CRO questions about the science of a particular trial, she added.

McNair also said WCG is seeing more adaptive clinical trials, which “can mean anything from interim analysis and reassessing the sample size, to a randomization scheme that varies subject to subject…which would be a much more complex adaptive design.” Although she also noted that WCG has yet to see an adaptive trial for a company intending to get a drug approved as the FDA has yet to approve any drug based on a pivotal study with an adaptive design.