Transcript olson_6

Drug Safety Strengthened by
Technology and Data Integrity
Lisa Olson, SEC Associates, Inc.
FDA Regulatory & Compliance Symposium
Cambridge, August 26, 2005
Agenda?
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What's Going on Now?
Some Problem Areas
What's Changing?
How is Risk Manifested?
Important Focus
Business Value of Accurate Systems
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What's Going On Now?
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Current Environment
• Product problems
• Need to see early signals
• Increasing interactions
– Multiple chronic conditions
– Insurance promoting the "quick fix" (drug)
• Physicians are rushed
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Current Environment
• Pressures
– Congress
– Patient
– Industry
– Various organizations (trade, patient advocacy,
disease research)
• Need/want to look at safety from research
through to manufacturing and use
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Current Environment
• FDA
– Wants to partner with industry
– Pressure to get drugs to market quickly
– Yet, under scrutiny for not protecting the public
• Industry
– Economic and competitive pressures
– Bad press
– Changing the way we approach therapies
(more individualized)
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Current Environment
• Move towards electronic health records
• Almost too much information to analyze –
large amount of data
• Computer usage increasing – storage,
capture, analysis
• Reliance on automation is increasing
• Safety measures change and may be
electronic (ECGs, specialty labs)
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Current Environment
• Reduce risks or deal with appropriately
throughout life cycle of the product
• Want to be able to look at data crossprogram
• Increased interest in quick solutions
AGHGHG!!
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Some Problem Areas
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Problem Areas
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Wide variety of "solutions"
Systems don't talk to each other
Increased outsourcing
More information coming from multiple
parties
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Problem Areas in Research
• Separation of drug safety data from clinical
data management (reconciliation task)
• We do QA of CDM – what about SAEs, PVG?
– What checks are done on the data?
– What about coding – is it accurate?
– Versions of dictionaries?
• Any check that periodic safety reports are
correct?
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Problem Areas
• We focus on accuracy of collection – what
about the analysis?
• Need to ensure availability of data
These problems are solvable, but
you do need to address them
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What's Changing?
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Critical Path
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FDA's Critical Path Initiative
Make right decisions based on reliable data
Need better assessment of safety early on
Use new technology, but take care with it
Look at data cross-company (need for
standards)
• Want to be able to analyze data quickly, but
watch out for bias which could invalidate
study
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What's Different
• Data mining will be critical
– Ability to slice and dice
– Ability to quickly aggregate
– But must be accurate
– Hard to mine, if in multiple places
• Health (medical) records vs. clinical trial
records – can they be the same?
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What's Different
• Importance of PAT – finding a process or
measurement problem that might cross
products
• Consider infrastructure that is needed
– Staff roles changing
– QA staff vs. scientists
– Computer security
– Analysis tools – training!
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How is Risk Manifested?
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Risk
• Wrong decisions based on bad data
• Data being changed inappropriately
• Misrepresented results (not necessarily an
error message!)
• Unavailability of data/records
– Technology issues
– Training
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Risk
To Patient?
Or risk of
getting
caught?
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Important Focus
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Realize Impact of:
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Inaccurate software
Incorrect use
Control over changes
Integrity controls
Security
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What Else Is Important
• Employing the right skills
• Auditing/verifying suppliers – know what
you're buying!
• Compliance (this is implied, but maybe
shouldn't be)
– Clinical investigators
• Compliance is everyone's responsibility
– All uses
– All analyses
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Business Value of
Accurate Systems
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The "V" Word
What does "validation" mean?
Simply, is it working correctly?
(And can you prove it?)
Why is this a bad thing?
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Validation
• Arguments:
– "It takes too long – let's just put it in and fix it
later"
– "I'm buying it – the vendor should ensure it's
correct"
– "Nobody else is doing this"
– "We won't get inspected"
– "We'll know if it's not working"
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A Contradiction
• We are tending to trust computers more at
a time when:
– Impact of software bugs is greater
– Timelines are too short to build in quality
– We are trying to link incompatible things
together
– Security exposures are increasing
– We are using other companies (and their
systems) to do our processes, without
adequate investigation
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Value
• Get things right the first time (more
expensive to fix and patch)
• Decrease overall costs of system
deployments
• Avoid making wrong decisions based on
incorrect data
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Value
• "Hidden" costs
– Company reputation
– Staff confidence
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Partner with suppliers – get better products
Minimize risks – appropriate mitigation
React vs. prevent
Not an add-on; just part of your business
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In Summary
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In Summary
• For safety, remember the importance of:
– Accurate data
– The right data
– Availability / timeliness
• Use technology, but make sure it's right!
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Thank You!
Lisa Olson
Principal Consultant
SEC Associates, Inc.
2100 Gateway Centre Blvd., Suite 150
Morrisville, NC 27560
Phone: (919) 532-1241
Fax: (919) 467-1109
[email protected]
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