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Feds looking to fund clinical studies on comparative effectiveness of devices

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The federal Patient-Centered Outcomes Research Institute added three medical device-related topics to its list of priority research areas that are eligible for enhanced funding under the Pragmatic Clinical Studies initiative.

In the initiative's third funding round opened on Aug. 18, comparative trials studying cardiology, hip fracture and surgical mesh are invited to apply. Letters of intent are due by Oct. 1. The $90 million program will fund selected studies for a maximum of $10 million over 5 years. Specifically, the three new topic areas whose trials will surely involve devices are:

  • Comparative effectiveness of medical treatments versus invasive procedures for patients with asymptomatic carotid artery disease;

  • Comparative effectiveness of different surgical options for hip fracture in older patients; and

  • Comparative effectiveness of different types of surgical mesh as well as the use versus nonuse of mesh in repair of pelvic floor dysfunction.

Comparative trials often prove influential in guiding clinical decisionmaking. The well-publicized results of the Courage trial in 2007 shifted heart failure therapy away from procedures like stenting and toward medication. Courage found that patients who received a bare-metal stent and medication performed similarly to those on medication alone.

"The clinical trial results definitely did affect physicians' perceptions of stenting," GlobalData research analyst Priya Madhavan told FierceMedicalDevices. "Prior to that time you definitely had overstenting as an issue, with physicians implanting drug-eluting stents in cases where aggressive medical therapy can also be a viable treatment."

The latter two areas involve notable cases of device failure. Manufacturers of vaginal mesh and metal-on-metal hips are embroiled in lawsuits after both products were found to be deficient and to cause issues such as urinary problems, pain during sexual intercourse and the release of metal ions into the bloodstream. But conventional hip replacements continue to sell well. And a host of nonsurgical products are being developed that facilitate patients' exercise of the pelvic floor muscles. Some involve interactive video games and are being funded on the crowdsourcing site Kickstarter.

PCORI Executive Director Joe Selby--Courtesy of PCORI

The three new priority areas push the list of research topics of interest to PCORI past 20 items. Other topics include the reduction of cardiovascular disease in underserved populations and the comparison of pharmacologic and nonpharmacologic strategies for the treatment of migraines. Funded studies can involve randomization of patients or simply large-scale observation.

"We're excited about this latest step in our continuing efforts to support research that will address key unanswered health questions that affect millions of people," PCORI Executive Director Dr. Joe Selby said in a statement. "The findings from the trials we'll fund through this initiative have great potential to provide information that can be directly adopted by healthcare providers because the studies will focus on practical questions and be conducted in typical care settings, rather than specialized research settings."

- read the release
- see the program's website
- get more on the winter 2015 funding cycle and the list of priority research areas (PDF)

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