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Compliance In Focus


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Posted by John Lehmann on Wed, Mar 04, 2015

Clinical Research - Does the Evidence Make Sense?

The New York Times published an article that poses an important question to researchers- Do new medical procedures, products, and drugs work better than the old practices that they commonly replace?  It is a similar question that consumers are faced with every time a new version of their favorite cell phone is released- it is new, but is it necessarily better?

Topics: New England Journal of Medicine, New York Times, Clinical Research

Posted by John Lehmann on Wed, Mar 04, 2015

The Cost-Saving Power of Study Evidence

There has been a downward trend in certain knee procedures for osteoarthritis. According to a recent study published , researchers from Emory University examined the trend in hopes of showing the effectiveness of study evidence and the positive impact it can have on study dollars. This is because the New England Journal of Medicine published many reports between 2002 and 2008 associated with changes in clinical practice patterns.

Topics: New England Journal of Medicine, Study Evidence, Cost-Savings

Posted by John Lehmann on Wed, Mar 04, 2015

Is the US Faster in Bringing High-Risk Devices to Market?

There has been a consistent criticism that it takes longer to have a high-risk medical device in the United States than in Europe.  This argument has been used to bolster an argument that the FDA should lower its standards for approving medical devices, which is denying Americans access to innovative technology. According to an article in the New England Journal of Medicine this might not be the case.  It points out that a review of data suggests it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the U.S. as it does in the four largest European markets (Germany, France, Italy and Britain).

Topics: High-Risk Devices, New England Journal of Medicine, United States

Clinical Research Training Requirements
Featured Resource

clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.