May 26, 2006

In September 2005, the National Institute of Allergy and Infectious Diseases (NIAID) convened an independent working group under the NIAID National Advisory Allergy and Infectious Diseases Council. The ad hoc group was convened to carefully review the important regulatory activities of the Institute’s Division of AIDS (DAIDS) and to identify any areas for improvement.

Louis W. Sullivan, M.D., former Secretary of the U.S. Department of Health and Human Services and President Emeritus of Morehouse School of Medicine, chaired the working group. Members of the working group were chosen because of their expertise in regulatory activities; human clinical trials research (including international trials); distribution of therapeutics in resource-poor countries; and bioethics.

The working group conducted its evaluation between September 2005 and April 2006 and completed its report in May 2006. Its charge was to evaluate 

• The current organizational structure of DAIDS relating to regulatory matters
• The roles and responsibilities of individuals involved in regulatory processes, including those involved in decision-making
• Written and unwritten standard operating procedures for carrying out the regulatory work of DAIDS
• Formal and informal channels of communication for dealing with regulatory matters within DAIDS, and between DAIDS and DAIDS-supported investigators
• The timeliness of completing critical functions

In addition, the working group was to immediately inform the NIAID Director of any concerns regarding patient safety.

The working group used several strategies to gather information relevant to its charge, including interviews with DAIDS staff, DAIDS-funded investigators and other knowledgeable individuals. In addition, it reviewed “best practices” from relevant organizations such as private sector companies and other institutes at the National Institutes of Health.

The working group recently delivered its final report to the NIAID. Importantly, its review found no evidence of patient safety having been compromised. Other key findings of the group are as follows: 

• DAIDS personnel are highly motivated, committed and hard working.
• Rapid growth, complexity and international expansion have been major contributors to tensions and operating inefficiencies within DAIDS.
• There have been important deficiencies in key areas of DAIDS management.
• DAIDS trials in resource-poor countries face important regulatory and ethics challenges not fully under DAIDS control and common to all sponsors.
• Effective resolution of these issues is time-sensitive. Resolution of certain key issues requires urgent attention. 

The working group made five recommendations to meet the current challenges confronting DAIDS regulatory activities:

• Revise the organizational structure and authority for developing regulatory policies and overseeing regulatory activities
• Improve DAIDS and regulatory leadership
• Determine and achieve appropriate FTE levels and competencies for staff engaged in regulatory activities
• Facilitate the resolution of the common challenges of U.S. sponsors and funders conducting clinical trials in resource-poor countries
• Take action to assure timely and effective implementation of these recommendations

NIAID is committed to strengthening the conduct of regulatory activities within DAIDS and across the Institute and has initiated several activities to this end. For example, following discussions in the winter of 2005 (and predating the convening of the working group), NIAID began harmonizing the clinical trials processes throughout the Institute. This concerted effort to standardize clinical trials processes within DAIDS and across NIAID, which incorporates specific recommendations made by the Sullivan Working Group, will continue. H. Clifford Lane, M.D., director of NIAID’s Division of Clinical Research, leads this initiative, in collaboration with a subcommittee of the NIAID Executive Committee that includes representatives from all NIAID divisions involved in clinical research. In addition, NIAID will lead an international effort to address the challenges of conducting clinical trials outside the United States with an emphasis on trials in resource-poor countries, as identified by the Sullivan Working Group.

NIAID also has already begun addressing the working group’s specific recommendations regarding the leadership and organizational structure of DAIDS and its regulatory activities, and will take action on these recommendations in a timely manner. The NIAID leadership is committed to ensuring that an optimal organizational structure, good management practices and adequate resources are fostered in DAIDS to enable the staff to function most effectively.

NIAID appreciates the extraordinary work of Dr. Sullivan and this working group in helping the Institute identify these areas for improvement in the regulatory processes of the Division of AIDS.

More detailed information on the Sullivan Working Group and its findings can be found in the Sullivan Working Group Report and NIAID Q&A: Sullivan Working Group Report.

Media inquires can be directed to the NIAID News and Public Information Branch at 301-402-1663, niaidnews@niaid.nih.gov.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov

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