Yasuyuki_Sahara
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MHLW’s Measures to Ensure
the Reliability of Investigator-Initiated
Clinical Trials
Ministry
of
Health,
Labour
and
Welfare
For
people,
for
life,
for
the
future
Yasuyuki
Sahara
(MD,
MPH)
Director,
Research
and
Development
Division,
Health
Policy
Bureau
Ministry
of
Health,
Labour
and
Welfare,
JAPAN
28
February
-‐1
March,
2013,
Tokyo,
Japan
Health
Research
Overview
of
Japanese
Regula3ons
on
Health
Research
IntervenOonal
studies
intended
for
applicaOon
for
markeOng
approval
of
drugs
and
medical
devices;
under
PharmaceuOcal
Affairs
Law
(PAL)
• IntervenOonal
studies
• ObservaOonal
studies
• Human
Genome/Gene
Analysis
Registration Purpose
Academic Purpose (other than Registration)
Clinical
Trials
InvesOgator-‐iniOated
Health
Research
Investigator-
initiated
CTs
Company-
initiated
CTs
Clinical
Trials
under
PAL
2
J-‐GCP*
based
on
ICH-‐GCP
Major
Guidelines
for
Health
Research
in
Japan
Is
the
purpose
collecOng
data
for
the
applicaOon
of
markeOng
approval
of
drugs
or
medical
devices?
Clinical
Research
outside
of
PAL
Clinical
Trials
under
PharmaceuOcal
Affairs
Law
(PAL)
Human
Stem
Cell
Clinical
Trials
Yes
No
Gene
Therapy
Clinical
Trials
Epidemiol
ogical
Research
Other
Clinical
Research
Guidelines
on
Clinical
Trials
Using
Human
Stem
Cells
Guidelines
for
Gene
Therapy
Clinical
Trials
Ethical
Guidelines
for
Epidemiol
ogical
Studies
Ethical
Guidelines
for
Clinical
Studies
Genome/
Gene
Analysis
Ethical
Guidelines
for
Human
Genome/
Gene
Analysis
*GCP:
Guideline
for
Good
Clinical
PracOce
4
J-‐GCP
based
on
ICH-‐GCP
Clinical
Research
outside
of
PAL
Clinical
Trials
under
PharmaceuOcal
Affairs
Law
(PAL)
Human
Stem
Cell
Clinical
Trials
Gene
Therapy
Clinical
Trials
Epidemiol
ogical
Research
Other
Clinical
Research
Guidelines
on
Clinical
Trials
Using
Human
Stem
Cells
Guidelines
for
Gene
Therapy
Clinical
Trials
Ethical
Guidelines
for
Epidemiol
ogical
Studies
Ethical
Guidelines
for
Clinical
Studies
Genome/
Gene
Analysis
Ethical
Guidelines
for
Human
Genome/
Gene
Analysis
4
InsOtuOonal
Review
Board/Ethics
Review
Commi]ee
review
by
MoH
review
by
MoH
start
of
study
Main
Provisions
in
GCP
Main
Provisions
in
Ethical
GLs
Standards
for
Preparing
CTs
l
OperaOng
Procedures
l
Protocol
l
InvesOgator’s
Brochure
l
CompensaOon
to
Subjects
Standards
for
CT
Management
l
InvesOgaOonal
Product
Control
l
InformaOon
on
ADRs
etc.
l
Monitoring
l
Audit
-‐
l
Clinical
Trial
Reports
l
Record
Keeping
l
OperaOng
Procedures
l Protocol
X
l
CompensaOon
to
Subjects
X
l
Handling
of
Adverse
Events
X
X
l
Self-‐inspecOon
(if
necessary)
l
Report
of
result
summary
X
Comparison
between
Japanese
GCP
and
Ethical
Guidelines
for
Clinical
Studies
X : no specific provisions in the Ethical Guidelines
Main
Provisions
in
GCP
Main
Provisions
in
Ethical
GLs
Standards
for
ConducOng
CTs
(1)
InsOtuOonal
Review
Board
l
Establishment
and
Review
l
InformaOon
Disclosure
l
Record
Keeping
(2)
Medical
InsOtuOon
l
ResponsibiliOes
of
Head
l
Clinical
Trial
Office
l
Record
Keeping
(3)
InvesOgator
l
ResponsibiliOes
of
InvesOgator
l
PreparaOon
of
CRF
(4)
Informed
Consent
of
Subjects
l
Wri]en
Informed
Consent
(1)
Ethics
Commi]ee
l
Establishment
and
Review
l
InformaOon
Disclosure
X
l
ResponsibiliOes
of
Head
X
X
l
ResponsibiliOes
of
InvesOgator
X
l
Wri]en
Informed
Consent
Comparison
between
Japanese
GCP
and
Ethical
Guidelines
for
Clinical
Studies
X
:
no
specific
provisions
in
the
Ethical
Guidelines
Agenda for Revision of the Ethical Guidelines for
Clinical Studies (by summer 2013)
The Issues raised in the Subcommittee
for the Ethical Guidelines for Clinical Studies
u System for Improving Quality of the Examination of the
Ethics Committee
u Assurance of Quality of the Clinical Research
－ e.g. Confirmation of the Reliability of Data
u Method of the Informed Consent
－ especially for the scope and method of general consent etc.
7
Improvement
in
ethics
and
quality
of
clinical
research
Thank
you
for
your
a]enOon.
8
Ministry
of
Health,
Labour
and
Welfare
For
people,
for
life,
for
the
future