Drug Safety Strengthened by Technology and Data Integrity
Drug Safety Strengthened by Technology and Data Integrity Lisa Olson, SEC Associates, Inc. FDA Regulatory & Compliance Symposium Cambridge, August 26, 2005 © 2005 SEC
Agenda? • • • What's Going on Now? Some Problem Areas What's Changing? How is Risk Manifested? Important Focus Business Value of Accurate Systems © 2005 SEC Associates, Inc. 2
What's Going On Now? © 2005 SEC Associates, Inc. 3
Current Environment • Product problems • Need to see early signals • Increasing interactions – Multiple chronic conditions – Insurance promoting the "quick fix" (drug) • Physicians are rushed © 2005 SEC Associates, Inc. 4
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 © 2005 SEC Associates, Inc. 5
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) © 2005 SEC Associates, Inc. 6
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) © 2005 SEC Associates, Inc. 7
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!! © 2005 SEC Associates, Inc. 8
Some Problem Areas © 2005 SEC Associates, Inc. 9
Problem Areas • • Wide variety of "solutions" Systems don't talk to each other Increased outsourcing More information coming from multiple parties © 2005 SEC Associates, Inc. 10
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? © 2005 SEC Associates, Inc. 11
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 © 2005 SEC Associates, Inc. 12
What's Changing? © 2005 SEC Associates, Inc. 13
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 © 2005 SEC Associates, Inc. 14
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? © 2005 SEC Associates, Inc. 15
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! © 2005 SEC Associates, Inc. 16
How is Risk Manifested? © 2005 SEC Associates, Inc. 17
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 © 2005 SEC Associates, Inc. 18
Risk To Patient? Or risk of getting caught? © 2005 SEC Associates, Inc. 19
Important Focus © 2005 SEC Associates, Inc. 20
Realize Impact of: • • • Inaccurate software Incorrect use Control over changes Integrity controls Security © 2005 SEC Associates, Inc. 21
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 © 2005 SEC Associates, Inc. 22
Business Value of Accurate Systems © 2005 SEC Associates, Inc. 23
The "V" Word What does "validation" mean? Simply, is it working correctly? (And can you prove it? ) Why is this a bad thing? © 2005 SEC Associates, Inc. 24
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" © 2005 SEC Associates, Inc. 25
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 © 2005 SEC Associates, Inc. 26
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 © 2005 SEC Associates, Inc. 27
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 © 2005 SEC Associates, Inc. 28
In Summary © 2005 SEC Associates, Inc. 29
In Summary • For safety, remember the importance of: – Accurate data – The right data – Availability / timeliness • Use technology, but make sure it's right! © 2005 SEC Associates, Inc. 30
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 lolson@SECAssociates. com © 2005 SEC Associates, Inc. 31
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