America Living With AIDS

The double-blind, placebo-controlled, randomized clinical trial has
long been considered the most reliable
method for evaluating new medical
interventions. It has often been
regarded as the "gold standard" for the
establishment of efficacy of proposed
new medical treatments. In ideal circumstances, efficacy protocols would
include strict entry criteria defining a
subject's stage of disease, age, and
health status, and would be designed
to minimize the number of confounding variables posed by other disease
conditions or drug interactions. Many
scientists believe such study designs
offer the most rapid answers to the
question of how well a therapy works.
The HIV epidemic, however, has
prompted a reassessment of the methods of clinical research and the use of
placebo controls. It has brought a new
sense of urgency and concern about
the appropriate balance between the
need to bring new, safe, and effective
drugs to market for treating lifethreatening illnesses and the need to
protect the welfare of experimental
subjects, many of whom see access to
these unproven therapies as their only
hope. Some consider this access to
experimental therapies a right. The
HIV epidemic has also brought a
recognition that the validity of the scientific process itself depends upon the
ability to translate scientific findings
to the real world.
The strict entry criteria traditionally associated with the controlled clini
cal trial have excluded many who wish
to participate in HIV-related trials.
Women, drug users, people with
hemophilia, and children, among others, were initially excluded from HIVrelated trials because they did not
meet the strict entry criteria for participation.
Such criteria made access
to experimental therapies
virtually impossible for a w(
whole communities of
people with HIV disease.
(Later in this chapter the
Commission identifies Rei
obstacles to participation no
in trials that still exist for
people of color, women,
children, drug users, people with hemophilia, and
prisoners.) The appropriate medical management
of people with HIV disease often involves the use of many
different drugs at one time. Each new
complication of HIV disease and its
prevention or treatment makes entry
into a classically designed clinical trial
difficult since the classically designed
protocol would attempt to minimize
the number of variables posed by
other disease conditions or drug interactions.
Efforts have been made to address
the concerns expressed by many about
the strict entry criteria for participation in controlled clinical trials. The
Commission believes these efforts
should continue and be expanded,
since greater participation by traditionally excluded groups will not only
provide increased access to experimental therapies for many people with

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