K Arnold Chan, FISPE, Post-Marketing Safety Signal Detection and Refinement for Medical Products

54 Pages·2014·1.64 MB·English

Post-marketing safety signal
detection and refinement for
medical products
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產產產產 巿巿巿巿
陳建煒
K. Arnold Chan
臺大醫院醫學研究部
臺大醫學院
2014.10.24 ICPE 11
Potential conflict of interest
(cid:1) Faculty of a public university
(cid:1) Consultant to private companies
(cid:1) Fees go to an education and research account
2014.10.24 ICPE 2
Outline
(cid:1) Current view about regulation of medical
products
(cid:1) Safety surveillance
(cid:1) Methods
(cid:1) Examples
(cid:1) Q & A throughout
2014.10.24 ICPE 3
-
Benefit-Risk Assessment of a medical product
- Continuous assessment / monitoring throughout
a product’s life cycle
Improve public health
U
$$$ Blockbuster
Moderate benefit
Approval
threshold
$ Moderate return
on investment
Neutral
value
Public health disaster
A threshold for withdrawal?
New Indications and Risk Management
IND NDA
2014.10.24 ICPE 44
Why?
(cid:1) Some historical
examples
(cid:1) cisapride
(cid:1) troglitazone
(cid:1) rofecoxib
(cid:1) SSRIs use among
adolescents
(cid:1) aprotinin
(cid:1) rosiglitazone
2014.10.24 ICPE 5
Strom. JAMA 2006; 295: 2072-5, Figure
(cid:1)
2014.10.24 ICPE 6
FDA Amendment Act and The Sentinel Initiative
www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM124701.pdf
We are seeing the emergence of a science of
safety. This science combines the growing
understanding of disease and its origins at the
molecular level (including understanding of
adverse events resulting from treatment) with
new methods of signal detection, data mining,
and analysis, enabling researchers to generate
hypotheses about, and confirm the existence,
and causal factors, of safety problems in the
populations using the products.
2014.10.24 ICPE 77
FDA Amendment Act and The Sentinel Initiative
www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM124701.pdf
In addition, personalized medicine is generating
information about the unique genetic and
biologic features of each person that some day
will help determine how he or she responds to
treatment. Using these tools, FDA has
increasingly adopted a life-cycle approach to
product development and evaluation.
2014.10.24 ICPE 88
FDA Amendment Act and The Sentinel Initiative
www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM124701.pdf
This kind of approach should be used for all
medical products so that safety signals
generated at any point in the process can be
evaluated along with relevant benefit risk data
to inform treatment choices and regulatory
decision making. FDA regards improving risk
and benefit analysis to be one of the important
facets of the science of safety that urgently
requires additional development.
2014.10.24 ICPE 99
Some general concept
(cid:1) Public health practice vs. ivory tower
academic research
(cid:1) Safety should never be considered alone
(cid:1) Benefit-Risk evaluation
(cid:1) Continuous assessment
(cid:1) Product life cycle management
(cid:1) Surveillance within the therapeutic risk
management framework
(cid:1) Science of Efficacy and Science of Safety
2014.10.24 ICPE 10