Drug Safety Strengthened by Technology and Data Integrity
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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]