Responses to NIH-Specific Recommendations (Extracted from: America Living with AIDS)

#2 The Secretary of Health and Human Services should direct the
National Institutes of Health, the Health Care Financing
Administration, and the Health Resources and Services
Administration to work together to develop a series of
recommendations to address the obstacles that keep many
people from participating in HIV-related clinical trials, as
well as the variables that force some people to seek
participation in trials because they have no other health
care options.
The NIH is committed to addressing barriers to participation
in clinical trials, as evidenced in the activities described
under the response to C-1. A specific component of the
interagency agreement between NIH and HRSA and planned for
the collaboration under Title IV is to jointly sponsor
regional meetings to bring together representatives of
respective grantees to identify, discuss, and solve problems
associated with barriers to the participation in clinical
trials.
The NIH is also concerned about those HIV-infected
individuals who participate in clinical trials in order to
obtain health care. For any disease, clinical trials are
not an adequate substitute for primary health care, since
care under a protocol is only related to the protocol and
once the protocol is completed, the individual is left
without primary health care. This is even more problematic
for HIV-related clinical trials because of.the complex
nature of HIV infection and its sequelae. For example, if a
patient participating in a trial for a therapeutic for an
opportunistic infection (OI) experiences problems unrelated
to the protocol or the OI under study, treatment for the
unrelated conditions would require using valuable research
funds for provision of health care.
The NIH is collaborating with AHCPR to collect health
services utilization data as part of the conduct of natural
history studies. This effort should provide information
relevant to these issues.