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Compliance In Focus
Posted by Stephani Hulec on Thu, Oct 31, 2013

FDA Shutdown - How Have Clinical Trials Been Affected?

In our recent blog , we discussed the backlog of clinical trial submissions the FDA now faces,FDA Shutdown  How Have Clinical Trials Been Affected which was caused by the temporary government shutdown.  The articles cited in that blog focused on the impact of new FDA submissions, and particularly on the detrimental effects to start-up companies.  However, how have ongoing clinical trials been affected during this time period?  More importantly, how have the lives of the patients on the other side of that experimental drug or device been affected?

In short, there has been a hugely negative impact to many clinical trials, especially those funded government agencies, such as the National Institutes of Health (NIH).  There have been many articles, such as this, over the past few weeks that discuss the repercussions of our government shutdown, as many clinical trials were forced to place their enrollment on hold.  In addition, there have also been several poignant news stories covering how the shutdown has affected specific clinical trial patients, such as here and here.

In fact, many would agree with the writer of this article, who states that this is the “saddest paragraph you’ll read about the government shutdown today”:  “At the National Institutes of Health, nearly three-quarters of the staff was furloughed.  One result:   director Francis Collins said about 200 patients who otherwise would be admitted to the NIH Clinical Center into clinical trials each week will be turned away. This includes about 30 children, most of them cancer patients, he said”.

This MedCityNews article nicely summarized several major areas in healthcare that have been negatively impacted.  Although the shutdown has been officially lifted, how are the patients who were turned away from enrolling in clinical trials, or had to wait to receive treatments?   How will the FDA manage to catch up on all new clinical trial submissions?

What can our government learn from this instance, to ensure that these patients can still receive the treatments they so desperately need and will not be placed in harm’s away, in the very likely event that a shutdown occurs again?

Photo Credit:bcostin


Topics: Government Shutdown, National Institute of Health, FDA


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