Monday, January 9, 2012

Dr. Tamara Norton Smith on the state of regulation and clinical trials

The 2011 Partnerships in Clinical Trials Executive Summary is a richly detailed document for any clinical trial industry professional.  In-depth notes taken directly from the 20th Annual Partnerships in Clinical Trials event are available at your fingertips.  This week, we highlight the portion reviewing Dr. Smith's keynote "Clinical Partnerships at a Crossroad – The Intersection of Quality and Oversight."  Take some time to look at last year's key takeaways and information as we gear up for the March Partnerships in Clinical Trials Event.

Download the executive summary here.

Here is a portion of this featured session from Dr. Norton Smith's presentation:

Norton Smith assured the audience that the FDA is working very closely with regulatory groups worldwide to develop a unified methodology for auditing and inspecting international trials, but stressed that “the FDA is dealing with many of the same strains that you’re facing in your own organizations.”
In fact, Norton Smith estimated the FDA currently inspects less than 1% of foreign trials, which in turn has put the onus on sponsors and their partners to keep an unusually tight grip on the reins of their international operations. 
Norton Smith pointed out that in 2008, roughly 200,000 subjects participated in trials at no fewer than 6,500 different sites. Such volume would be logistically impossible for the FDA to manage from here in the US, so the FDA has set up offices around the world to test various models in order to accommodate more than 68 countries involved in drug applications, and more than 39 different countries for biologics. (Editor’s note: Figures specific to medical devices were unavailable.)
Of particular note, the FDA is increasingly relying on memoranda of understanding (MOU) arrangements internationally: training these different countries’ officials and ensuring they understand FDA regulations and are well versed in policy.
“The agency has had a great deal of experience and success with the MOU model here in the US,” Norton Smith said. “There are certain tasks that the FDA will actually defer to the state governments to take care of for them; however, the FDA still has a responsibility to make sure the state is doing what they’re supposed to be doing under their federal MOUs.” Implicitly, the same would hold true in an international model.
Clearly, international MOUs alone will not provide the coverage or security FDA requires, and Norton Smith confirmed this to be the case. “Since I’m not an FDA representative anymore, I’m going to tell you the truth: That burden is going to shift from the US government to the sponsor,” she stated.

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