CLINICAL RESEARCH UNITS FOR THE TREATMENT OF PATIENTS WITH HIV DISEASE - OPERATIONAL ISSUES AND COMPONENTS NEEDED TO CONDUCT CLINICAL-TRIALS

Clinical trials are of paramount importance for the development and ev aluation of new therapies for patients with human immunodeficiency vir us (HIV) disease. The objective of an HIV clinical research unit is to conduct high quality clinical research with patients who have HIV dis ease. The conduct of these research studies requires accurate and comp lete data collection. Coordination of the patients' primary care must be complemented by a working knowledge of the relevant ethical issues. In addition, technical, managerial, and clinical expertise is needed for conducting the trials and collecting data. To accurately plan the research, personnel and resource allocation should be periodically ass essed. Clinicians, particularly those who have not previously conducte d clinical trials or who are considering the incorporation of a resear ch program into a primary care setting, must be familiar with these is sues in order to create and supervise this type of clinical research u nit. A smoothly running clinic observing a defined cohort of patients is attractive to government agencies and pharmaceutical sponsors for f unding of clinical trials and research projects.