Q-Notes T March?, 1998 T PAGE3
NC-based drug company developing new resources for the war on HIV
by Doug Stokke
Special to Q-Notes
RESEARCH TRIANGLE PARK—Phar
maceutical industry giant Glaxo Wellcome has
unveiled plans for two new programs to assist
people living with HIV.
They are tesdng a data collection system in
a few sites around the country that should pro
vide the best picture thus far of the health, so
cial and ecomomic impact HIV has on infected
individuals.
The other programT being evaluated is an all-
emcompassing 11-part course designed to em
power and educate infected individuals and
their care-givers in a host of HIV-related areas.
Controlled studies on the effectiveness of the
course are currendy being conducted with a
dozen medical agencies across the nadon, one
of them in Durham.
Just the fiicts
A computerized database system which will
— for the first dme — produce important ob-
servadonal informadon on clinical, economi
cal, humanisdc and epidemiological outcomes
in patients with HIV or AIDS has been
launched. Healthcare professionals at four clini
cal sites across the US are in the process of en
tering a variety of informadon into the data
base from padents with HIV or AIDS who have
volunteered to pardcipate.
The CHORUS (Collaboration in HIV
Outcomes Research — US) database program
will ultimately enroll approximately 8000 de-
mogtaphically representadve padents with HIV
or AIDS and is expected to become the pre
mier disease management data source for HIV/
AIDS. CHORUS will provide the most com
prehensive informadon of any such HIV data
base available and will include data on such
parameters as clinical outcomes of patients,
economic/healthcare utilizadon, quality of life,
epidemiology and patient satisfaction with
healthcare.
Housing of data and database management
will be provided independendy by Research
Triangle Insdtute (RTI) of Research Triangle
Park, NC. Data review, analysis, publicadon
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and presentadon vnll be the responsibility of
an independent database advisory board which
includes national thought leaders in HIV re
search and treatment, as well as representatives
from the HIV community. Study questions
addressed to the database, whether clinical,
pharmacoeconomic or otherwise, will be de
termined and prioritized by the database advi
sory board. The CHORUS database program
was conceived and created by the Care Man
agement Division at Glaxo Wellcome. The first
analyses of data from CHORUS are expected
to be presented at scientifrc meedngs as early
as the summer of 1998..
“CHORUS offers the first ‘real-time’ obser
vational smdy of HIV that has the capacity and
power to study the clinical and nonclinical as
pects of HIV disease,” said Stephen Becker,
MD, co-chair of the CHORUS scientific advi
sory board. “Many important questions facing
clinicians, patients and policy makers can be
answered only through this type of longimdi-
nal and multidimensional smdy. The retrospec
tive and prospective elements of CHORUS are
likely to provide a robust and generalizable data
source for research of the complex and interac-
uve elements of HIV.”
Through the use of the HealthPoints ACS
computerized medical record system, CHO
RUS collects patient data at the point of care
and thus enables real-time data collection. At
the end of each day, data which have been made
anonymous are capmred and transmitted to a
central information repository at RTI. In addi
tion, healthcare utilization, quality of life and
satisfaction with healthcare will be documented
in writing and provided to RTI for data entry.
Extensive quality assurance and systems vali
dation programs have been put in place to en
sure the accuracy, security and integrity of data
entered into the CHORUS database.
“Due to the large demographically diverse
population expected to be enrolled, and as more
antiretrovirals and other drugs become avail
able, CHORUS has the potential to answer
some very important scientific questions that
are not appropriately addressed by traditional
clinical trials,” said Kevin Frost, director of clini
cal research and information for the American
Foundation for AIDS Research (AMFAR).
Patient participation is completely voluntary
and individual confidentiality is protected. Pa
tients must sign a consent form before any of
their data are collected and they may withdraw
from the database at any time. The CHORUS
study has been reviewed and approved by in
stitutional review boards.
“CHORUS is a unique collaboration be
tween the HIV treating, research and patient
communities and representatives of the phar-
itiaceutical industry, created to provide a cen
tralized, credible source for the most compre
hensive HIV data available,” said Gary Slatko,
MD, MBA, vice president of the Care Man
agement Division at Glaxo Wellcome. “It is the
only resource that combines clinical, economic
and patient-perceived outcomes on a national
level with the goal of making possible new effi
ciencies in diiucal trial and research design, and
to stimulate improvements in HIV disease
management.”
The four sites and principal investigators
who will be entering data into the CHORUS
database program are Pacific Horizon Medical
Group, San Francisco, CA (Stephen Becker,
MD); Pacific Oaks Medical Group, Beverly
Hills, CA (Anthony Scarsella, MD); Compre
hensive Care Center, Nashville, TN (Stephen
Rafianti, MD); and Liberty Medical, New York,
NY (Douglas Dietrich, MD).
Better equipping and empowering persons
living with HIV and AIDS to make informed
health decisions at a time of unprecedented
advances in the treatment of the disease is the
principle behind an innovative new program
aurently being piloted in several sites through
out the country.
THE (Tools for Health and Empowerment)
Course is an 11-week, interaaive, educational
care management program for persons living
See WM on page 22
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