Clinical research units for the treatment of patients with HIV disease: operational issues and components needed to conduct clinical trials

Article Abstract:

Primary care clinics may be one of the best places for AIDS research to be conducted both for the patient's benefit and for the benefit of learning more about earlier intervention in the course of the disease. Patients may benefit from continuity of care if they do not have to travel to different sites and meet with different practitioners in order to be enrolled in clinical trials. Primary care sites also have the advantage of enrolling potentially large numbers of participants. There may be differences between treatment and research. Bringing research into the patient's primary care setting will ensure that communication between the primary physician and the research team works in the patient's interest. Personnel considerations involve issues of management and definition of roles of study coordinators and study managers. Physical space considerations and laboratory needs are also discussed.

Research, Management, Medical research, AIDS (Disease), AIDS research

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Clinical trials and rare diseases

Article Abstract:

A study of itraconazole in preventing fungal infections in people with chronic granulomatous disease illustrates the difficulty of doing research on rare diseases. Because this disease is rare, it took 10 years just to enroll 39 patients. So the researchers had to follow a different procedure for doing the study. Doctors may have to accept this because these studies could not be done otherwise.

Editorial, Methods, Evaluation, Prevention, Clinical trials, Drug therapy, Itraconazole, Mycoses, Chronic granulomatous disease

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