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FDA Regulatory & Compliance Symposium Cambridge, August 26, 2005

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Drug Safety Strengthened by Technology and Data Integrity Lisa Olson, SEC Associates, Inc. FDA Regulatory & Compliance Symposium Cambridge, August 26, 2005. Agenda?. What\'s Going on Now? Some Problem Areas What\'s Changing? How is Risk Manifested? Important Focus

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Drug Safety Strengthened by Technology and Data Integrity

Lisa Olson, SEC Associates, Inc.

FDA Regulatory & Compliance Symposium

Cambridge, August 26, 2005

  • What\'s Going on Now?
  • Some Problem Areas
  • What\'s Changing?
  • How is Risk Manifested?
  • Important Focus
  • Business Value of Accurate Systems
current environment
Current Environment
  • Product problems
  • Need to see early signals
  • Increasing interactions
    • Multiple chronic conditions
    • Insurance promoting the "quick fix" (drug)
  • Physicians are rushed
current environment1
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
current environment2
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)
current environment3
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)
current environment4
Current Environment


  • Reduce risks or deal with appropriately throughout life cycle of the product
  • Want to be able to look at data cross-program
  • Increased interest in quick solutions
problem areas
Problem Areas
  • Wide variety of "solutions"
  • Systems don\'t talk to each other
  • Increased outsourcing
  • More information coming from multiple parties
problem areas in research
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?
problem areas1
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

critical path
Critical Path
  • 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
what s different
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?
what s different1
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!
  • Wrong decisions based on bad data
  • Data being changed inappropriately
  • Misrepresented results (not necessarily an error message!)
  • Unavailability of data/records
    • Technology issues
    • Training

To Patient?

Or risk of getting caught?

realize impact of
Realize Impact of:
  • Inaccurate software
  • Incorrect use
  • Control over changes
  • Integrity controls
  • Security
what else is important
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
the v word
The "V" Word

What does "validation" mean?

Simply, is it working correctly? (And can you prove it?)

Why is this a bad thing?

  • 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"
a contradiction
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
  • 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
  • "Hidden" costs
    • Company reputation
    • Staff confidence
  • Partner with suppliers – get better products
  • Minimize risks – appropriate mitigation
  • React vs. prevent
  • Not an add-on; just part of your business
in summary
In Summary
  • For safety, remember the importance of:
    • Accurate data
    • The right data
    • Availability / timeliness
  • Use technology, but make sure it\'s right!

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]