America Living With AIDS

C H A P T E R FIVE
CLINICAL TRIALS
AND TREATMENTRELATED RESEARCH
he following chapter deals exclusively with clinical trials and related issues of drug development. Such focus should not
be construed as an indirect statement about the relative importance of various other
research endeavors. In fact, the Commission recognizes and appreciates the importance of the larger biomedical research enterprise and the enormous contributions it
has made to all diseases, particularly HIV disease. This chapter focuses particularly
on the extensive attention and input on clinical trials and drug development that
occurred during months of Commission hearings and discussions with people living
with HIV disease and their caregivers. Clearly, other areas of research are of critical
importance (particularly vaccine studies and behavioral and social science research),
and the Commission will be focusing attention on these areas in the coming year.
OVERVIEW
The lack of primary health care services for many people with HIV disease has forced
them to look to clinical trials for basic primary care, as well as for access to experimental treatments. Although the Commission firmly believes access to experimental
treatments is an essential component of health care services for all people with HIV
disease, the Commission also believes that obstacles to receiving primary care outside
the clinical trial setting must be addressed so that the research setting is not the only
place of access for experimental treatments. The Secretary of Health and Human
Services should direct the National Institutes of Health (NIH), the Health Care
Financing Administration (HCFA), and the Health Resources and Services Administration (HRSA) to work together to develop a series of recommendations to address
the obstacles that keep many people from participating in HIV-related clinical trials,