The working group was charged with evaluating the following:

• 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 for 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 asked to immediately inform the NIAID Director of any concern regarding patient safety.

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 group. Members represented expertise in human clinical trials research (including international trials); distribution of therapeutics in resource-poor countries; food and drug law and regulations; and bioethics. The membership was as follows: 

• John D. Arras, Ph.D., Porterfield Professor of Biomedical Ethics and Professor of Philosophy, University of Virginia
• Gail Cassell, Ph.D., Vice President for Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases at Eli Lilly and Company
• Susan S. Ellenberg, Ph.D., Professor of Biostatistics, University of Pennsylvania Center for Clinical Epidemiology and Biostatistics; Associate Dean for Clinical Research in the School of Medicine
• Maria Freire, Ph.D., Chief Executive Officer of the Global Alliance for TB Drug Development
• Peter Barton Hutt, LL.B., LL.M., Senior Counsel, Covington & Burling
• Gary Schoolnik, M.D., Professor of Medicine, Microbiology and Immunology, Stanford School of Medicine

The working group had a senior consultant, Michael Calhoun. Mr. Calhoun is former Chief of Staff under Dr. Sullivan at the U.S. Department of Health and Human Services. He is a senior healthcare executive with extensive experience in organizational leadership, strategic planning and execution for complex delivery systems. His broad experience encompasses domestic and international healthcare, government and public policy, and leadership in government, academia and the private sector.  Mr. Calhoun assisted the working group by

• Fact-finding for the panel, including the conduct of interviews
• Managing the agenda and facilitating working group meetings
• Assisting the working group with their deliberations
• Drafting the final report of the Sullivan Working Group

 The Working Group identified five general findings:

• DAIDS personnel are highly motivated, committed and hard working.
• Rapid program 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 of key issues requires urgent attention.

The working group provided five recommendations to help remediate their identified findings:

• 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 United States’ sponsors and funders conducting clinical trials in developing 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 already initiated several activities to achieve this goal.  For example, following discussions in the winter of 2005 (and predating the convening of the Sullivan Working Group), NIAID began harmonizing the clinical trials processes throughout the Institute. This effort to standardize clinical trials processes within DAIDS and across NIAID will continue, strengthened by the incorporation of the specific recommendations made by the Sullivan Working Group. H. Clifford Lane, M.D., director of NIAID’s Division of Clinical Research, leads this effort. This initiative has been facilitated by the establishment of a subcommittee of the NIAID Executive Committee charged with review of NIAID clinical research policies.  In addition, NIAID will lead a broad-based international effort to address the regulatory and ethical 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 has already begun addressing the working group’s specific recommendations regarding the leadership and organizational structure of DAIDS and its regulatory activities, and will act 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.