12:00 AM
Nov 25, 2013
 |  BioCentury  |  Product Development

Golden State IRB

California consortium aiming to create centralized IRB for clinical trials

The Partnership to Accelerate Clinical Trials is trying to eliminate the duplication of administration and regulation that can delay multicenter clinical trials by creating a centralized institutional review board and master clinical trial agreement recognized by research institutions across California.

The aim is to have at least five clinical trial sites across the state accept a common IRB and master clinical trial agreement by 2Q14 and have at least five clinical trials managed through the consortium's system by the end of next year.

The Partnership to Accelerate Clinical Trials (PACT) is the first project to come out of the Bay Area BioEconomy Initiative, which officially debuted this month with the goal of growing the San Francisco Bay Area bioeconomy.

Operators of clinical trial sites across the U.S. already can form their own IRB or designate an existing one to review and monitor studies being carried out at the site. While this helps ensure each institution has an IRB that is cognizant of local issues that trial sponsors need to address, it also makes setting up multicenter trials inefficient and prone to delays.

A sponsor looking to set up a multicenter trial in California may need to undergo an IRB review and negotiate a clinical trial contract agreement for each trial site, said Clay Johnston, who leads PACT and is director of the Clinical and Translational Science Institute and associate vice chancellor of research at the University of California, San Francisco.

"Each institution has its own regulations and contracting offices. It generally takes around 60 days for each IRB review, and contract negotiations usually take around 50 days but can sometimes take six...

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