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How the Government Shutdown will Affect Clinical Trials and Biomedical Research

Trials will stop enrolling new patients and work at the National Institutes of Health will come to a halt.
April 8, 2011

If the federal government does shut down this weekend, clinical trials will stop enrolling new patients and researchers at the National Institutes of Health (NIH) will have to put their studies on hold. Internal research at the agency involves thousands of scientists and hundreds of lab and animal facilities and consumes about ten percent of the NIH’s $31 billion budget. Whether the involuntary hiatus will prove to be an inconvenient blip or a serious impediment to clinical research will depend on just how long the standstill lasts. Federally funded scientists working outside of NIH are unlikely to be greatly affected by a short shutdown.

But patients with fast-progressing diseases, such as some types of cancer, who had hoped to enter new clinical trials don’t have says to spare. According to a blog from ABC news, there are currently seven new procedures scheduled to start next week at the NIH Clinical Center 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.

NIH is quietly preparing for the shutdown by designating employees who will be allowed to come to the facility to care for animals or protect ongoing research, such as tissue cultures, from damage.

According to an article on ScienceNow;

NIH Deputy Director for Intramural Research Michael Gottesman e-mailed ScienceInsider yesterday that each of NIH’s 27 institutes and centers is identifying people who would be “excepted” from the shutdown. That includes clinical staff; fire, security, and animal care personnel; and a few employees “who are protecting research investments.”

But the details are sketchy. Any public discussion of the contingency plans is forbidden “for political reasons,” says one high-level official, explaining that the government can’t look like it’s preparing for a shutdown. Even internal e-mails are now verboten, this source said; instead, planning has been done the old-fashioned way, by word of mouth.

That said, “there seems to be a coherent plan,” a lab chief said. A few months ago, PIs submitted lists of essential personnel, including most physicians, animal caretakers, and others who will maintain experiments or cell lines that can’t be shut down. The numbers ScienceInsider heard ranged from 50% of a group that does nonprimate work and clinical trials to just 10% of one institute’s entire intramural program. But there’s no word whether those lists have been approved.

The uncertainty is stressful, says one PI, who was allowed to designate only himself and one other lab member to maintain lab animals and cell cultures for a pause of indefinite length. “A great deal of treasure will be lost if this shutdown happens” because experiments may be damaged, he predicted.

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