The Treatment Branch of the AIDS Program, NIAID is responsible for coordinating the U.S. Government's efforts to evaluate therapies for AIDS and its related infections. Clinical studies are performed at 35 separate clinical sites where new protocols are implemented. In addition to its responsibility for coordinating the AIDS Clinical trials effort, the Treatment Branch must conform to regulations and reporting requirements established by the Food and Drug Administration, oversee data collection and analysis by its Clinical Trials Coordinating Center, develop and track clinical protocols, and maintain a database containing up-to-date information on investigational drugs and preclinical drug development. Because of the complexity and volume of these tasks, the Treatment Branch has a need for research support services to augment their present effort. The contractor will first establish databases to track all concept sheets and protocols, Adverse Drug Reactions, IND applications, and drug distribution. They will then be responsible for generating reports from these databases on a regular basis. The contractor will also supply support in medical areas, including a major role in protocol writing and development, analysis of data from on-going clinical trials, and information retrieval for projects involving new agents for trialing AIDS. Finally, the contractor will provide logistical and technical support for the various committees involving Treatment Branch staff. These include the AIDS clinical Drug Development Committee, the Protocol Review Committee, and the various committees and of the AIDS Cooperative Group.
