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Breaking news from the FDA! 

Breaking news from the FDA....see this article from the Washington Post. We are currently enrolling in trials evaluating this new cholesterol-lowering medication. Call to see how you can take part in this exciting research (904) 730-0166 

http://www.msn.com/en-us/news/us/new-drugs-could-cut-heart-attack-stroke-risks/ar-BBkQM2b

 

Posted by Amy Autry Bush Tuesday, June 9, 2015 1:04:00 PM Categories: Breakthroughs

Caution! 

Last month my husband and I took a camping trip up to Crooked River State Park near St. Mary’s  Georgia. We had never been there before and had heard good things about the area, so we took a chance. It was lovely! The weather was great and it was very quiet and peaceful – the perfect weekend get-away.

On Saturday morning we went for a bike ride, and passed by a local watering hole – the Bloody Bucket (I kid you not!) – where the marquee invited us in for a cold beer. As compelling as that sounded, it was only nine o’clock in the morning so the establishment wasn’t yet open. But we couldn’t resist taking a photo of the sign leading up the front steps, “Caution stay right”…..

Well of course this got me to thinking about the various meanings I could attach to this cryptic comment, and because I am always looking for a larger context, I naturally thought about ethics and what that means in clinical research.

There are many layers of safeguards in place that serve to ensure ethical conduct in clinical research beginning with the sponsor’s initial research plan, called a protocol. Each protocol is carefully reviewed for ethics and safety by the FDA, and eventually by a third party called an Institutional Review Board. When the protocol has final approval, the IRB panel and the sponsor will provide oversight of the research program the entire time it is being conducted at each research site. If errors occur, there are reporting requirements that are strictly enforced. Knowingly providing false data and failure to report errors or safety events can result in serious consequences, and in egregious cases, the forfeiture of medial licenses for the physicians and staff involved. In other words, the regulatory officials mean business.

All that being said, the most important link in this chain is the local research physician and study coordinator who are looking out for patient safety first and foremost. For those of you who have taken part in a clinical trial, you know how seriously we take your health and well-being. For those of you who have yet to venture into the research realm – come on the adventure with us – our motto will always be to “stay right”.

Posted by Amy Autry Bush Thursday, May 28, 2015 4:00:00 PM Categories: Musings
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