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Entries in Government Shutdown (1)

Wednesday
Apr062011

The Impact of a Government Shutdown on NIH Clinical Trials

Comstock/Thinkstock(BETHESDA, Md.) -- Clinical trials involving new drugs to help cure diseases such as cancer, including cancer in children, will be stopped or slowed by any government shutdown, a spokesman for the National Institutes of Health said on Wednesday.

A shutdown would mean no new studies will be started at NIH, where everyone is a federal employee.

At the NIH Clinical Center there are currently seven new procedures, or protocols, scheduled to start next week that will not begin if the government shuts down over the weekend.

Ongoing studies at the NIH Clinical Center will not admit new patients, according to John Burklow, associate director for communications and public liaison at NIH, which “will delay the completion of all studies currently active at the Clinical Center.”

Burklow says there are approximately 640 clinical trials (and 1,443 variations, or protocols, within those clinical trials) at the Clinical Center that will stop admissions of new patients. Of the 640 clinical trials that will stop admitting new patients, 285 are for patients with cancer and 60 involve children with cancer.  

One new patient -- a child from a poor family with a rare disease -- was supposed to visit NIH on Monday to be added to a clinical trial, and had made special arrangements including traveling to NIH on a Miles for Kids program on Sunday. But none of this will happen if there’s a shutdown: no new patients, after all.

It’s unclear how a shutdown would impact other ongoing clinical trials outside the NIH campus, with NIH grants, since the doctors and other assistants are not federal employees.

But new trials will be stopped, including the phase III study of a promising new cancer drug -- Anti-CTLA4 -- at the Philadelphia’s Eastern Cooperative Oncology Group. That study will not be able to start on schedule if the government runs out of money, which will happen Friday night unless a deal is struck.

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