ACTG Highlights

ISSUES AND ANSWERS

What is Being Done to Increase Enrollment of Underrepresented Populations in ACTG
Clinical Trials?
The ACTG has made substantial efforts to increase the numbers of minorities, women,
intravenous drug users (IVDUs), and children enrolled in ACTG clinical trials. Between 1987
and 1989, the percentage of minorities (Hispanics and blacks) in ACTG trials increased from 18
to 28 percent; the percentage of women rose from 5 to 11 percent; and the percentage of
IVDUs has remained fairly stable at 11 percent.
A total of 417 infants and children have been enrolled in ACTG studies. During the past 18
months, NIAID increased from 2 to 15 the number of ACTUs devoted exclusively to pediatric
research. In addition, supplemental support is being provided to existing ACTUs to allow for
increased enrollment of children in ACTG studies. A collaborative arrangement with the
National Institute of Child Health and Human Development (NICHD) enables NICHD clinical
trials sites and investigators to participate fully in ACTG studies. Current research priorities
also include greater emphasis on pediatric studies.
New initiatives will make AIDS clinical trials even more accessible to all of these groups.
MAID has budgeted a total of $9 million to be awarded in FY 1990 for the following:
(1) minority institutions not currently involved in the ACTG will receive cooperative
agreement awards through the the AIDS Clinical Trials Infrastructure for Minority
Institutions;
(2) competitive supplements will be awarded to some existing ACTG sites to expand
the enrollment of currently underserved populations; this initiative is a
collaboration with the National Institute on Drug Abuse, which is providing an
additional $2 million for sites making a major effort to recruit IVDUs. This
collaborative effort will also establish linkages between ACTUs and NIDAfunded Treatment Research Units and Centers to combine their respective efforts
to reach the IVDU population.
(3) supplemental funds will be awarded to existing ACTG units to increase
enrollment of children and pregnant women.
What is NIAID's Position on the Use of Placebos in Clinical Trials?
The purpose of placebo controls in clinical trials is to allow direct estimation of the effects of
the experimental treatment on the natural history of the disease. With potentially fatal
conditions, placebos are appropriate only when there is no known effective treatment. Even
then, the appropriateness of placebo controls depends on many other factors such as the
seriousness of the condition and standard community practice. When there is a known effective
treatment for a serious condition, that agent is used as the control arm--e.g., AZT is the control
arm for ongoing evaluations of ddl. Placebo controls may be appropriate and optimal in studies
of prophylaxis of some Ols where only a small proportion of the patients are likely to develop
the 01 during the course of the investigation.

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