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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

NIH Clinical Trials Registry Accepts New Applications During Shutdown

October 11, 2013—The National Institutes of Health (NIH) Oct. 4 resumed processing new applications on ClinicalTrials.gov, the agency’s clinical trial registry, following a brief hiatus due to the government-wide shutdown.  The agency had stopped registering new trials starting Oct. 1, but later received permission to recall federal employees that had been furloughed.

Representative William Keating (D-Mass.) is credited with drawing attention to the problem after constituents were unable to enroll in new clinical trials at the Dana-Farber Cancer Institute.  Rep. Keating approached NIH Director Francis Collins, M.D., Ph.D., to address the issue.

A posting on the NIH registry website now reads, “ClinicalTrials.gov is open, however it is being maintained with minimal staffing due to the lapse in government funding. Information will be updated to the extent possible, with priority given to processing registrations of new trials and critical updates to existing entries, such as trial status and contact information for enrollment. The agency will attempt to respond to urgent operational inquiries.”

Many teaching hospitals require patients receiving experimental drugs to be formally enrolled in a clinical trial registered on ClinicalTrials.gov.  With the site reopened, clinical trials have resumed as scheduled after the delay.  However, patients hoping to join trials at the NIH hospital will still have to wait until the government shutdown ends.  According to the HHS contingency plan, in the event of a shutdown, “NIH would not admit new patients (unless deemed medically necessary by the NIH Director).”

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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org