the difficulties for IRs wanting to do randomized trials

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

the difficulties for IRs wanting to do randomized trials

Postby Cece » Thu Mar 07, 2013 11:03 am

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3058757/
The lack of randomized, controlled trials (RCT) for interventional radiology (IR) is one of the major problems of IR, which has been discussed for many years (SIR Dotter—lecture 2008). The reasons for this are simple but difficult to overcome. IR does not control the patients, so they often do not control the trials. Second, performing a RCT is expensive and funding for device trials is very difficult, because there is still no regulatory need to produce RCT data for registration of a device. Finally, the IR market is small compared with, for example, interventional cardiology, and the industry is not willing to invest large sums, which are needed for a RCT. That is why we always see these small, underpowered, one-arm studies in IR, never reaching any level of evidence.

What does, "IR does not control the patients, so they often do not control the trials" mean? Patients are sent by primary doctors to IRs for one-time treatment, and then go back to the primary doctors for future care? In CCSVI, this is where we might see neurologist-controlled trials? Because the neurologists control us as MS patients...

The next two reasons have to do with funding. The device manufacturers don't need to fund a trial because there's no requirement that they do before the device gets approved for use. The IR market is small -- does 600,000 people with MS in the US change that or is that still small? -- and so the industry is not willing to invest large sums.

How did other researchers wanting to do interventional radiology randomized controlled trials overcome these obstacles? The link above discusses an ASTRAL trial about renal artery stenting. Where did their funding come from?
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Re: the difficulties for IRs wanting to do randomized trials

Postby HappyPoet » Thu Mar 07, 2013 2:40 pm

Maybe they applied for and received a grant from somewhere?
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Re: the difficulties for IRs wanting to do randomized trials

Postby Cece » Thu Mar 07, 2013 3:18 pm

Grants would be helpful!
Here's an interventional radiology study called PIVOT that received $10 million from the National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI). http://www.sirweb.org/news/newsPDF/ATTRACT.pdf

Here are SIR foundation grants: http://www.sirfoundation.org/grants-awards/

Here's a renal denervation study funded by the catheter and specific generator manufacturer: http://esciencenews.com/articles/2011/0 ... sults.last

Basically we need NIH and their $10 million.
:sad:
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Re: the difficulties for IRs wanting to do randomized trials

Postby Cece » Fri Mar 15, 2013 12:47 pm

The study was funded by Kaleida Health, UB, the Direct MS Foundation (Canada), Volcano Corp, ev3 Corp and many individuals who have a personal stake in MS research.

Sources of funding for the PREMiSe trial.
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