I noticed that Outsourcing Pharma had a blip on Investigators’ frustrations with IRB review timelines. See below to a link to the full article:
http://www.outsourcing-pharma.com/Clinical-Development/IRB-delays-a-frustration-for-investigators
The thought that an IRB efficacy study was needed, gave me pause for another thought. AAHRPP publishes IRB stats on an annual basis; so I perused the 2009 numbers. Per their data, seventy five percent of organizations have their own IRB. This sounds reasonable to me. Fifty three percent of these IRBs rely on outside IRBs for additional support, again, seems reasonable. Now here is where it gets tricky – Seventy two percent of these IRBs outsource less than ten percent of their workload. I wonder why only ten percent? Then I looked at the workload. The average IRB oversees about 400 protocols. Mean time from submission to approval is 48.8 days, although mean time from submission to review is 25 days. It appears that many Investigators are not getting the IRBs what they need to approve the study? The part that amazed me was the IRB organization staffing. On average, each full time equivalent (fte) employee is managing 139.8 protocols. Doesn’t that sounds like an amazing amount of work? While almost all the organizations noted that the process was improving, 87.6% reported that the workload was increasing. One last note, it appears that as the number of protocols per organization increases, the number of deviations reported per protocol decreases. I’m not sure how that could make sense?
Sounds like too much to do with too little time for me. As the Pharma Industry increases their outsourcing, why don’t the IRBs?
AAHRPP 2009 report
http://www.aahrpp.org/www.aspx?PageID=354