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October 2009
Vol. 19 No. 10
Patient Care and Science
NIAID Considers Revamp to Clinical Trials Infrastructure, Works to Address Research Barriers

Officials with the National Institute of Allergy and Infectious Diseases (NIAID) are examining the possibility of expanding the purview of NIAID’s clinical trials networks to include a focus on tuberculosis, hepatitis C, influenza, and possibly antimicrobial resistance. IDSA supported this proposal in an October letter to NIAID Director Anthony S. Fauci, MD, and urged an additional focus on drug-resistant bacterial infections. 

An NIAID working group is exploring what the infrastructure for these new networks might look like and what funding models would be best employed, according to a recent article in NIAID News. The working group was one of eight created following a July NIAID consultation on the clinical trials infrastructure that brought together outside ID researchers, including IDSA’s representative, William Burman, MD, and NIAID officials. During the consultation, Dr. Burman discussed an IDSA policy statement published in Clinical Infectious Diseases in August, which identified and provided solutions to regulatory barriers that slow important ID research.

Authored by Dr. Burman and Robert Daum, MD, and developed with IDSA’s Research Committee, the statement focused on the impact of the Health Insurance Portability and Accountability Act (HIPAA), redundancy in the adverse event reporting process, barriers related to local review of multicenter studies and pediatric research, and the role of institutional review boards (IRBs) in quality improvement projects (see IDSA News article).

An NIAID working group will consider several recommendations that flowed from the July consultation, including: the creation of a centralized IRB at NIAID, the development of an appropriate definition for “adequate” oversight and monitoring, and the simplification of the adverse event reporting system, among other steps.
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