Transcript Slide 1

“Standard of Care”
• The term “Standard of care” refers to the nature of
the prevention and/or care that will be provided to
participants in research
• It has been used variously to refer to:
– the general care and treatment that investigators agree
to provide all participants in clinical research
• And more specifically to:
– the quality of care that should be provided to people in
the control arm of a RCT – i.e. those that are not
receiving the experimental intervention
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The specific issues
• What standard of care should be
assured individuals who participate
in HIV prevention trials?
– Prevention package? (condoms, risk
reduction counseling, clean needles?)
– Care related to the disease under
study?
– Other ancillary care?
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The larger issues…
• Is it ethically necessary to improve
health care as we conduct research?
• Is it ethically permissible to do
research in the absence of adequate
health care?
• Is it ethically acceptable to do no
research if we are unable to improve
health care?
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The Standard of Care Debate
• Intense international discussion and debate
• Debate heated up around controversial HIV trials to
prevent mother to child transmission in the
developing world
• Commentators questioned the ethics of trials that
used a “placebo” when an existing regimen 076 had
been shown to reduce peri-natal transmission of HIV
in the United States
• Defenders argued that the 076 protocol was not
“relevant” to the health care needs or priorities of the
developing world, because it could not viably be
implemented
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What does ethics guidance say?
• Individuals in the control arm must receive:
– “An established effective intervention” (CIOMS)
– “The best current prophylactic, diagnostic and therapeutic
method” (Declaration of Helsinki, 2002)
– Ideal: “best proven therapy;” Minimum: “highest level of care
attainable in light of … the circumstances listed" (UNAIDS
vaccine guidance)
– Ideal: “best proven;” Minimum: “the best intervention
available for the disease as part of the national health
system” (Nuffield Council)
– “Highest achievable” standard should be the goal (Benatar &
Singer, BMJ, 2000)
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Does placebo debate apply to
vaccine & microbicide trials?
• No….vaccine and microbicides trials do not have
classic “no treatment arm”
• All participants receive standard prevention
package (e.g. condoms, counseling, STD treatment)
• Placebo is used to blind researchers and
participants to which group has experimental
product
• Issue is what should be part of “prevention
package”
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SOC Debate as Applied to
Microbicides
• What package of prevention services should
participants in the trial be provided?
– High standard HIV counseling, condoms, STD screening,
treatment, clean needles, methadone treatment?
Investigator’s Dilemma
The more effective your prevention package is, the more
difficult it becomes to determine whether the product works
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Standard of Care (continued)
• What other health care should be provided during
the trial?
– Pap tests? Family Planning? Malaria Rx?
• What HIV care should individuals who seroconvert
during the trial be provided?
– TB prophylaxis, nutrition counseling, support groups,
MTCT, ARVs?
• What care, if any is due women who are screened
out of the trial because they are already HIV+?
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List of Care Issues Debated in Microbicide Trials
Enrolled
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Basic HIV education re: transmission
Condom promotion/risk reduction
VCT – pre/post counseling
STI screening
STI treatment
Reliable contraception
Initial CD4 counts for HIV+
MTCT
Cervical cancer screening
Care for cervical dysplasia/cancer
Psycho-social support for HIV+ women
Prophylaxis for HIV Ois
TB/Malaria treatment/other care
ARVs
M
M
M
M
M
?
-?
M?
M?
?
M?
A
?
Screened
M
M
M
M
M
A
M?
A
A
M?
?
?
A
A
Community
?
?
?
?
?
?
A
A
A
A
A
A
A
A
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Working within unacceptable realities
• According to the 2003 Global HIV Prevention
Working group and UNAIDS:
– Only 1 in 10 people living with HIV have been
tested for the virus
– Only 5% of pregnant women in sub-Saharan
Africa have access to nevirapine to prevent
mother to child transmission
– In Latin America and the Caribbean only 14% of
risky sexual acts are protected with condoms
– Only 14% of people in current need of ARVs have
access to treatment
– In Eastern Europe, only 7.6% of IDUs have
access to programmes to help them stay
uninfected
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Standard of Care
How do we achieve new ideals?
• Heightened sensitivity to exploitation
• Aim for reasonable practical limits
• Ratchet the standard upwards
• Build capacity through real partnerships
• Follow the ‘spirit’ of Declarations
• Avoid ‘cook-book’ attitudes to ethics
• Consider: context / safety / logistics /
harm/benefit/sustainability
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Today’s deliberations are part of an
on-going conversation
•
South Africa Consultations – SAAVI and SMRI (Dec 2001,
August, Nov 2002)
•
Global Campaign/IAVI Treatment Consultation February, 2003
•
South African National Consultation April, 2003
•
WHO/UNAIDS Consultation on access to treatment, July, 2003
•
Global Campaign ethics consultation, October 2003
•
Ethical considerations in provision of care and treatment in
vaccine trials, June 2005 Brazil (follow up to Malawi, March
05)
•
UNAIDS consultations in Abuja, Bangkok, Durban & Geneva
•
The dialogue continues……
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