The Division of AIDS (DAIDS) Working Group on AIDS Clinical Trials Group Organization has developed several strategies designed to improve upon the existing strengths of the ACTG, the comprehensive clinical trials network sponsored by the National Institute of Allergy and Infectious Diseases.
The Working Group, established by NIAID Director Dr. Anthony S. Fauci in April 1993, was part of a comprehensive assessment of the ACTG that also included an external review of the scientific accomplishments and future directions of the ACTG. The charge of the Working Group was to review the mission of the ACTG, including the scope and structure, and to develop proposals designed to improve the management and efficiency of the ACTG. The strategies for organizational change address many of the important points raised during the scientific review, since the management and organizational structure must support the research agenda and scientific priorities of the ACTG.
The ACTG has 57 sites at U.S. academic medical centers conducting studies of promising therapies for HIV infections and related illnesses in adults and children. Since it began as the AIDS Treatment Evaluation Units in June 1986, the ACTG has conducted some 192 trials in more than 23,000 patients.
The Working Group on ACTG Organization presented the following strategies for organizational change at the national ACTG meeting held December 5-8 in Washington, DC.
* Separate the pediatric and adult components of the existing ACTG into two distinct entities, each with its own scientific agenda, administrative structure and resources.
* Grant governing authority and power to the leadership of both the adult and pediatric research efforts. Clarify the roles and responsibilities of DAIDS staff and their relationship to the leadership of both research networks.
* Change the process of ACTG peer review. Conduct a detailed assessment of the overall productivity and scientific plans of each cooperative group at the time of competing renewal; base decisions concerning the scope and magnitude of support for the group on the results of this review. The applications for individual institutional funding will then undergo peer review in the context of the overall group review, focusing on the institution's record and/or potential for contribution to the entire group effort.
The separation of the adult and pediatric ACTG and the implementation of these changes will address many of the concerns identified during the assessment process, while maintaining the breadth of scientific expertise and clinical trials capabilities.
DAIDS will continue to coordinate the overall ACTG strategy and allocate resources among NIAID's clinical trials programs. The ACTG leadership will set the Group's research agenda, establish operational procedures, monitor performance and recommend resource distribution among sites.
During the assessment, the Working Group conducted more than 60 interviews with ACTG participants, non-ACTG investigators, people with HIV, treatment research advocates, pharmaceutical company representatives and others. The Working Group also convened an ad hoc advisory group to obtain additional input from 25 ACTG participant and several clinical trials experts not directly connected to the ACTG. For additional ideas and guidance, the Working Group shared the findings and preliminary recommendations with the ACTG leadership during the ACTG Leadership Retreat in July 1993, the ad hoc ACTG Scientific Review Panel in August 1993, and the AIDS Research Advisory Committee in September 1993.
Many of the strategies developed by the Working Group will be pursued immediately. Implementation of others will occur at the time of the competitive renewal of the adult sites in 1996. The impact of these changes will be carefully monitored and evaluated during the next several years and additional changes will be pursued as needed to further enhance the scientific productivity of the ACTG.
NIAID, a component of the National Institutes of Health supports research on AIDS, tuberculosis, other infectious diseases, allergies and immunology. NIH is an agency of the U.S. Public Health Service, U.S. Department of Health and Human Services.
Copies of both reports "ACTG Assessment: Organization and Management" and "ACTG: Ad Hoc Scientific Review" are available from the NIAID Office of Communications, Building 31, Room 7A50, NIH, 9000 Rockville Pike, Bethesda, MD 20892.
Prepared by the Office of Communications National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda, Maryland 20892