FDA Regulatory & Compliance SymposiumCambridge, August 26, 2005

Drug Safety Strengthened by Technology and Data Integrity

Lisa Olson, SEC Associates, Inc.

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Agenda?

• 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 cross-program

• Increased interest in quick solutions

AGHGHG!!

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Some Problem Areas

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Problem Areas

• 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

• 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:

• 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

• 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! Thank You!

Lisa OlsonPrincipal ConsultantSEC Associates, Inc.

2100 Gateway Centre Blvd., Suite 150Morrisville, NC 27560

Phone: (919) 532-1241 Fax: (919) 467-1109

lolson@SECAssociates.com