S6-2 Borovecki DoH Vatican

23/01/2024
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POST-TRIAL OBLIGATIONS
Ana Borovecki
Andrija Stampar School of Public Health, School of
Medicine, University of Zagreb, Croatia
PAV
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POST-TRIAL OBLIGATIONS
1.1.Towards individual agents
1.1.1Obligations of access to care after research
a) Obligations of access to an intervention
identified as beneficial in a study
b)Obligation of access to other appropriate care
1.1.2.Obligations of access to information after
research
*Mastroleo I. Developing World of Bioethics, 2015.
1.2.Towards collective agents
1.2.1Obligations of access to care after research
a) Obligations of access to an intervention
identified as beneficial in a study
b) Obligation of access to other appropriate care
1.2.2.Obligations of access to information after
research
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HELSINKI DECLARATION
2000. 2008. 2013.
Article 30.
At the conclusion of the
study, every participant
entered into the study
should be assured of access
to the best proven
prophylactic, diagnostic and
therapeutic methods
inedited by the study.
Article 33.
At the conclusion of the
study, patients entered into
the study are entitled to be
informed about the
outcome of the study and
to share any benefits that
result from it, for example
access to interventions
identified as beneficial in
the study or other
appropriate care or
benefits.
Article 34.
In advance of a clinical trial,
sponsors, researchers and
host country governments
should make provisions for
post-trial access for all
participants who still need
an intervention identified
as beneficial in the trial.
This information must also
be disclosed to participants
during the informed
consent process.
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HELSINKI DECLARATION
2000. 2008. 2013.
– beneficial- by sound clinical
evaluation, evidence of safety
and efficacy
What level of evidence is
needed?
Access to essential healthcare/
other appropriate care?
Access to information?
2004 clarification
-during study planning
identified -described in the
study protocol for RECs
consideration
– participants entitled to be
informed of the outcome of
the study
– other appropriate care
– benefit sharing?
Not specified for example
beneficial intervention may
be other things other care
– negotiated by the
participants, sponsors and
community (Emanuel et al.)
– no more benefit sharing
– information disclosure to
participants in informed
consent
– RECs responsibility?
Responsible for assurance
of post trial access-
sponsors, researchers,
governments
– no other appropriate
care- because of the
inducement of local leaders
to pressure people to
participate in studies
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FUTURE CONSIDERATIONS
• 1.1.Towards individual agents
1.1.1Obligations of access to care after research
– part of the protocol and explained in the informed consent
– REC should evaluate it and decide if there are provisos whether to continue or not
– responsible for assurance of post trial access- sponsors, researchers, governments
• a) Obligations of access to an intervention identified as beneficial in a study
– beneficial- by sound clinical evaluation, evidence of safety and efficacy
• b)Obligation of access to other appropriate care
– must be provided together with access to an intervention
• 1.1.2.Obligations of access to information after research
– must be provided
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FUTURE CONSIDERATIONS
• 1.2.Towards collective agents
1.2.1Obligations of access to care after research
-part of the protocol and explained in the informed consent
– REC should evaluate it and decide if there are provisos whether to continue or not
– responsible for assurance of post trial access- sponsors, researchers, governments
• a) Obligations of access to an intervention identified as beneficial in a study
-beneficial- by sound clinical evaluation, evidence of safety and efficacy
• b) Obligation of access to other appropriate care
– must be provided together with access to an intervention
• 1.2.2.Obligations of access to information after research
– must be provided
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FUTURE CONSIDERATIONS
• Role of REC-s
– methodology of the research
-benefit risk ratio
– quality of informed consent
BENEFICENCE- post-trial access is a part of beneficence risk ratio
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FUTURE CONSIDERATIONS
• SPONSORS- obligations of provisions
• COUNTRIES- importance of national regulation of this
area
• INTRENATIONAL bodies- importance of reaffirmation of
these obligations – global justice
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R E F L E C T I O N PA P E R O N E T H I C A L A N D G C P A S P E C T S O F
C L I N I C A L T R I A L S O F M E D I C I N A L P RO D U C T S F O R H U M A N
U S E C O N D U C T E D
O U T S I D E O F T H E E U / E E A A N D S U B M I T T E D I N M A R K E T I N G
AU T H O R I Z AT I O N A P P L I C AT I O N S TO T H E E U R E G U L ATO RY
AU T H O R I T I E S , E M A
• Regulatory action/action plan:
• 1.The applicant for a marketing application authorization should provide EU Regulatory
Authorities with a description of the situation of trial participants with regard to post trial
access to treatment and medical care depending on their localization and the national or
regional health care system.The applicant should describe the provisions made for post trial
access to treatment and medical care for study participants depending on their localization and
the treatment and medical care otherwise available.This information can form part of the
clinical study report section on ethical considerations.
• 2.EU RegulatoryAuthorities should identify those studies that may give rise to special ethical
concern regarding access to treatment post trial and where applicable to seek additional
assurance that the solution was appropriate and ethically acceptable.
• 3.EU RegulatoryAuthorities will summarize this information in the PublicAssessment report.
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R E F L E C T I O N PA P E R O N E T H I C A L A N D G C P A S P E C T S O F
C L I N I C A L T R I A L S O F M E D I C I N A L P RO D U C T S F O R H U M A N
U S E C O N D U C T E D
O U T S I D E O F T H E E U / E E A A N D S U B M I T T E D I N M A R K E T I N G
AU T H O R I Z AT I O N A P P L I C AT I O N S TO T H E E U R E G U L ATO RY
AU T H O R I T I E S , E M A
• Regulatory action/action plan
• 1. EU Regulatory Authorities should develop a clear and detailed system for
regulatory actions in case of non compliance with ethical and GCP
requirements.
• 2.Where clear serious concerns are identify the EU Regulatory Authority
should communicate these concerns to the National Regulatory Authority of
the Country(ies) concerned.
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R E F L E C T I O N PA P E R O N E T H I C A L A N D G C P A S P E C T S O F
C L I N I C A L T R I A L S O F M E D I C I N A L P RO D U C T S F O R H U M A N
U S E C O N D U C T E D
O U T S I D E O F T H E E U / E E A A N D S U B M I T T E D I N M A R K E T I N G
AU T H O R I Z AT I O N A P P L I C AT I O N S TO T H E E U R E G U L ATO RY
AU T H O R I T I E S , E M A
• Information and possible action by regulators of countries outside EU/EE
• Request for additional information or action by the sponsor
• Inspection or re-inspection
• Rejection of data/exclusion of trial/negative opinion
• Education and Facilitation
• Warning
• Transparency regarding clinical trial conduct and compliance including non-compliant
Marketing
Authorizations
• Suspension of the MarketingAuthorization/Urgent Safety restriction /Revocation of
the MarketingAuthorization
• Penalties
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DISCOURS ANALYISIS
• actors and participants of the discourse- sponsors,researchers,
regulatory agencies,world organizations,governments,scientists
(bioethicists)
• the energy that drives the discourse – rules and regulations,consensus,
appeasement,issues of global justice
• attractors – world organizations,regulatory agencies,sponsors
• interpretative level of public discourse –ethical issues ,legal issues,
finical issues
• What did the community gain from the emergence and development of
public discourse?
• debate sometimes solutions for implementation and consensus but on
the level of individual societies not on a global level
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