Transcript The Role of Community Advisory Boards (CABs) in Resolving

The Role of Community Advisory Boards
(CABs) in Resolving Ethical Issues
by
Michael Marco
Clinical Study CAB & Treatment Action Group
Solid Organ Transplantation and
People with HIV Ethics & Policy Conference
Washington, D.C. -- 28 July 2001
Storming the NIH!
AIDS Coalition to Unleash Power (ACT UP)
May 1990
The Denver Principles (1983)
• “We are people LIVING with AIDS.”
• “We are not victims.”
• “We have the right to die – AND TO LIVE –
with dignity.”
• “We have the right to participate equally in
all organizations dealing with AIDS policy,
care, services, research & treatment.”
NIH/NIAID RFA: AI-98-013
ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM FOR AIDS
The awardees will have the capacity to conduct all phases of
clinical trials in patients with early infection to advanced [HIV]
disease. $95 million for all Group[s].
• Terms and Conditions of Award:
 GROUP: 14) Community Representation - The Group will develop and
implement a plan for community representation in Group activities. The plan
should address how the representatives' inclusion will make a substantive
contribution to the overall success of the Group .
 SITES: 7) Community Advisory Boards (CAB) - All units must establish a
CAB representative of the HIV infected community of the catchment area. The
unit should have plans that demonstrate how the CAB will be included in the
activities to substantively contribute to the success of the unit. Funds requested
in the application must be made available to the CAB for reimbursement of
reasonable expenses including representation at the annual Group meeting(s).
Adult Clinical Trials Group (ACTG)
Group
Leader
Operations
Center
Executive
Committee
Site Evaluation
Subcommittee
Statistical/Dat
a
Center
ACTUs
CABs
Scientific
Committees
Resource
Committees
Community Constituency
Group (CCG)
Research Agenda
Committees
----------------------Laboratories
ACTG CAB Mission Statement (Dec. 1997)
• The mission of the Community Advisory Boards (CABs) of the AIDS Clinical
Trials Group (ACTG) is to integrate community involvement in the AIDS Clinical
Trials Units (ACTUs) in order to advance HIV/AIDS research.
– CAB’s provide an opportunity for affected communities, especially clinical
trials participants to:
– understand the clinical research process;
– voice concerns regarding specific clinical studies, their development,
implementation and outcomes;
– give assistance concerning issues related to the accrual and retention of trial
participants;
– give clinical trial participants necessary advocacy;
– forge a viable partnership that will lead to improved knowledge of HIV/AIDS disease;
give a means to address grievance issues; and
– promote ethical research purposes and practices.
Phase III Data Monitoring Committee in
the Eastern Cooperative Oncology Group (ECOG)
• Membership
 At the December 1999 meeting, the spot designated for
the ethicist was officially given to a cancer
survivor/community representative.
 The ECOG DMC will consist of nine voting members
and seven non-voting members. All voting members are
appointed by the ECOG Group Chair. At least 5 of the
voting members will be from outside ECOG and will
have no other affiliation with the Group. At least one
outside member will be a biostatistician, and at least
one member will be a cancer survivor. The other
voting members will be selected to provide expertise in
medical oncology, hematology, cancer therapy
modalities, and biostatistics.
HIV Liver Transplant Clinical Study CAB
 Mike Donelly, Positive Health Partner/UCSF (SF)
 Alan Franciscis, HCV Advocate (SF)
 Jeff Getty (SF)
 Brian Klein, Hepatitis C Action & Advocacy Coalition (HAAC/SF)
 Brenda Lein, Project Inform (SF)
 Jules Levin, NATAP (NYC)
 Michael Marco, Treatment Action Group (NYC)
 Bruce Mirkin (SF)
 Mike Shriver, UCSF CAPS (SF)
Ins and Outs of Setting Up a CAB
• Should there be one national CAB run out of UCSF, or should we try
for independent CABs at each site? What about a national CAB and at
least one liaison per site?
• Will the surgeon, nurse and study coordinator find the time to attend
the CAB meetings? Should they be required?
• Will there be funding for CAB member[s] to attend a national CAB
meeting[s]? What about funding for outreach & educational projects?
• Who is the CAB member accountable to? Should there be minimum
standards of conduct?
MAKING USE OF YOUR LOCAL ACTG CAB
SITE
ACTU?
PI
CAB CHAIR
Cornell
YES (Columbia) Roy “Trip” Gulick Tim Horn/Tracy Swan
Georgetown
YES (Pitt)
Mayo
NO
Sinai
Princy Kumar
Yvette Delph (TAG)
YES (NYU)
Jeffrey M.
Jacobson
Bill Bahlman
UCSF
YES
Mark Jacobson
Billy Pick
Maryland
NO
Minnesota
YES
Henry H. Balfour
Lois Crenshaw (WEB)
Penn
YES
Harvey Friedman
Bryan C. Cole Smith (WEB)
Pitt
YES
John W. Mellors
Barbara Rutecki
Virginia
NO
Sensitive & Ethical Issues Facing
an HIV+ Transplant CAB (1)
• Since the beginning of AIDS, the mantra of many AIDS activists was
“ACCESS to life-saving medications at any cost!” What do we say to
patients in desperate need of a transplant who are ineligible for this study?
• It will be our job to explain to patients why certain exclusion criteria exist.
• Whom do we advocate for? The patient? The success of the study?
• Knowing that CD4 cells decline in HIV+ patients with progressive
liver disease, how will we deal with the patient who becomes
ineligible (CD4 <100) while waiting for a liver?
• What about cheating?
Sensitive & Ethical Issues Facing
an HIV+ Transplant CAB (2)
• Should the CAB advocate for a patient when an HMO has denied to
pay for the transplant on grounds that it’s experimental?
• What about the protocol’s mandate for patients to have social support?
What are there standards? Who sets them? Are CAB members
expected to be “buddies?”
• How do we make sure that patients on protocol understands all facets
of the study (the risk & other options). Are we to serve as educators?
Should we walk a prospective patient through the informed consent?
• Is it fair that a patient can be refused entry into the study because
he/she is HIV RNA detectable when when a site in the next state only
has a CD4 cell requirement?
Future Directions: Education & Communication (1)
CAB members will need to gain a basic knowledge of
transplant medicine to be rational and truly effective.
Future Directions: Education & Communication (2)
Surgeons & others in the transplant community need to
know that the natural history of HIV disease has changed
dramatically over the the past 10 years. The clinical
management of HIV disease with the advent of HAART
has made HIV/AIDS a “chronic and manageable
disease.”
Impact of HAART on the Incidence of Opportunistic
Infections in the EuroSIDA Cohort
HAART
Incidence per 100 pt -yrs
140
120
PCP
100
MAC
80
60
CMV retinitis
40
Toxoplasmosis
20
1992
1993
1994
1995
Year
Mocroft, et al. 1999
1996
1997
24
CD4 T Cell Reconstitution on HAART
150
CD4
100
Memory cell expansion
Cells
50
Memory cell
recirculation
Naïve cell regeneration
0
Autran, el. 1999
3
6
9
12
18
Month
Future Directions: Education & Communication (3)
Discussion of HIV/HCV coinfection natural history [time
to cirrhosis] should be based on large cohort studies
which stratify for CD4 cell count and alcohol use. When
done, it appears that only those patients with CD4 cells
counts <200 have an increased rate of fibrosis.
Median Expected Time to Cirrhosis According to CD4 Cell
Counts and Alcohol Consumption in HIV+ Patients and HIV
Controls from French HCV DOSVIRC Cohort
45
40
35
30
(HIV+) <200 cells/µL and
(HIV+) >200 cells/µL and
(HIV+) <200 cells/µL and
(HIV+) >200 cells/µL and
(HIV-) >50 g/d alcohol
(HIV-) <50 g/d
Years 25
20
15
10
5
0
Benhamou et al. 1999
>50 g/d alcohol
>50 g/d
<50 g/d
<50 g/d
Future Directions: Education & Communication (4)
At all times, we must remember that we’re in it for the
same reasons: the advancement of science and the good
of the patients.