S5-2 Osuji DoH Vatican

23/01/2024
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PTA & DOH (PART A): POST-
CLINICAL TRIAL ACCESS IN
LOW-RESOURCE SOCIETIES
Session 5:
Peter I. Osuji, PhD
Center for Global Health Ethics, Duquesne University Pittsburgh, PA
osujip@duq.edu
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Intro.
u Conflict of Interest: None, except a member of LMIC
Importance of Post-Trial Access (PTA)
u Appreciation of the importance of the PTA clause.
u Unethical for a research/Protocol not to have it.
u REC should reject such protocol -Allen G.R. Ross
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Access to proven/effective
interventions beneficial to participants
u Complaints of Pharmaceutical companies after the 2000 DoH review.
2000, Art, 30: “At the conclusion of the study, every patient entered
into the study should be assured of access to the best proven
prophylactic, diagnostic, and therapeutic methods identified by the
study.”
u Impossible to guarantee post-trial access immediately at the
completion of the research because it takes time to make available
the proven intervention to the study participants “without regulatory
authorization prior to introduction into the public health system in
the host country.”
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Consequences
u PTA clause has been downgraded from an ethical obligation of the
researcher to an item to be described in the research protocol and
informed consent process. The revision committees favored “the
feasibility arguments over the ethical reasons.”
u The requirement of 2013 does not guarantee post-trial access, and it
is weaker than the 2000 version which demands.
u Current, 2012: “Prior to a clinical trial, sponsors, investigators, and host
country govts should make arrangements for post-study access.” This may
allow the ethics committee to review the scope of it.
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Access to post-trial proven effective
interventions as a right
Is Access to post-trial proven effective interventions a
right of participants?
u It is a right; participants are entitled to post-trial access/benefits,
Necessity to avoid exploitation of participants (of LMIC population)
u Human dignity makes it unthinkable that a research participant in a
precarious health situation could later be left to his own devices
because he or she is no longer ‘useful.’” (Andanda and Wathuta, Human
Dignity, 145.)
u acc. DoH 2013 Art. 34 it “must be disclosed to participants during the
informed consent process.”
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Dangers of refusal or Withdrawal of
PTA from participants …
u In a breast cancer trial, many participants were denied PTA to
lapatinib, though it was proven beneficial where other drugs had
failed to prove effectiveness. With the provision of PTA in such trials,
participants could have enjoyed longer lifespan or symptom-free
survival.” =Death (Trowbridge RL, Walker S. The FDA’s deadly track
record. Wall Street J 2007)
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Some Proposals
-a. Researchers & sponsors of a study must provide benefits to the
individual participants in the trial, “health-related resources to the host
community,” and assist with infrastructure development.
-b. the sole requirement for ethical research is that sponsors and
researchers must make sure that informed consent is given voluntarily by
participants and that they are provided fair benefits for their
participation.
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Some Proposals contd
-c. because carrying out clinical trials is expensive in
today’s economy, sponsors and investigators should not be
required to provide health-related resources and
infrastructure to the host community in which the trial is
being carried out.
Requiring additional or more posttrial services could
discourage sponsors. (Vinay Prasad, et al., 2016. Ethics of Clinical Trials in Low-
Resource Settings, p2)
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RESPONSE
u How about solidarity with the poor and vulnerable?
u The UN’s goal to provide healthcare for all.
u Sustainability of health outcomes by empowering
HCPs/Professionals or local researchers in the host
community?
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Access to interventions/proven
effective/beneficial to the broader
community
How about Providing PTA to the broader community/Globe?
u should be available to all who need it globally. (Kurihara et al., 227).
u i. Because health is a human right. (Constitution of the WHO. 22 Jul 1946.) and
derived from “human dignity.” (UN The Universal Declaration of Human Rights. 10
Dec 1948.)
u ii. Acc. to the UN’s Sustainable Development Goals (SD 2),
the provision of health care is a goal that must be achieved without leaving
anyone behind (Kurihara et al., 227).
u iii. Equitable access to HC must be seen as an ethical responsibility of researchers
involving humans. Hence, we should demand it.
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“Ancillary care”
u How far will researchers take responsibility for the care of non-target
diseases when conducting a trial in LRSs? E.g.,
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-Being a Scholar/researcher activist.
u Being a Scholar/researcher activist. Being confronted by
the metaphor of the margin
making our research an emancipatory study wherein the
purpose of going to the marginalized/poor communities will
also be to express marginalized voices and present their
experiences in authentic ways.
u That is pushing social justice a bit harder
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Who is Responsible for Funding/
Provision of PTA?
Who should pay, fund, or provide the PTA?
u Brazil: bases PTA on the constitutional right to health and contends that
researchers/sponsors are to provide them.
u Pharmaceutical companies vs. the state:
u “the state should not be compel to take over the sponsors’ responsibilities.” (Wang Wei, et al.,
2012)
u PTA Host country government must support PTA and devise policies
along with sponsors and investigators so that providing PTA
does not significantly burden any stakeholder.
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Who is Responsible for Funding/
Provision of PTA? Contd.
u Special aid may be provided by governments and funding agencies to
provide PTA in developing and resource-poor nations.
u Special research grants may be awarded to sponsors/investigators who
have invented new drugs/interventions that were subjected to PTA.
This will encourage further research activities, which may otherwise
get diluted due to a larger focus on patient care than on hard-core
research.
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Framework for Assessing Cost &
Benefits in LMISs
u -Human Dignity
u -Fair PTA
u -Patient/people-centered –not profit.
u -Cost effectiveness of people centered research
u -Does the intervention work in a real-life setting, and can the results
be generalized to everyday practice, support decision-making by
patients, providers, and health system leaders,
u -Sustainable trials, providing capacity, infrastructure health
education,
u -Contrast explanatory and pragmatic trials.
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CONCLUSION ­THANK YOU
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