med dev webinar 27052015 total
TRANSCRIPT
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Finding the right
Medical Device
information in Embase
Presented by Sherry Winter and Ivan Krstic
May 27, 2015
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How Embase delivers critical information needed for successful
regulatory submissions (Clinical Evaluations and Post-Market
Surveillance)
• Device performance
• Device safety – finding Device Adverse Reactions
• Comparison of device with existing devices
Agenda
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Webinar control panel:
• ‘Ask a question’ for
questions and comments
• Option for full screen view
• Q&A at the end
Need to Know
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• Adverse device effects
• Information on competitors
• Comparisons between 2 or more devices
• Quality of Life/benefit studies
• I don’t search Embase for Medical Device information
Poll – What Medical Device information do you look for
in Embase?
How does
Embase support
Medical Device
research?
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Clinical Evaluations –
Gather information for successful regulatory submissions
Scientific literature lets you:
Potentially relevant
literature identified
Literature excluded,
with reasons
Literature excluded from clinical
evaluation, with reasons
Literature retrieved for
more detailed assessment
Literature with relevant useable data
Included in the clinical evaluation by outcome: • Device performance
• Device safety
• Device comparability (if applicable)
Have more successful reg.
submissions/ acquire CE mark
Lower development costs by
avoiding a clinical trial
Find all important information on
AE’s for similar devices
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Post-market surveillance –
Companies face growing regulatory pressure
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Post-market surveillance –
Avoid missing critical information
Conduct post-market surveillance • Have you identified all adverse effects for
your device? • Are there emerging adverse-event trends in
your device or similar devices that will influence your risk management strategy?
Comply with regulatory requirements • Do you have an effective literature
monitoring solution to ensure regulatory compliance?
Medical Device adverse event reporting rising rapidly. Device Matters. 2013. http://www.devicematters.com/article/medical-device-adverse-event-reporting-rising-rapidly
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Post-market surveillance/Device Safety
With thorough monitoring of
scientific literature, you are more likely
to identify critical AE’s, preventing:
Why Embase?
• Deep indexing - >3000 med dev terms
• Adverse device effect subheadings
• Comprehensive, current
• Search for classes of drugs/devices
• Weekly alerts
• Automate content delivery – API
• Literature monitoring solution with
QUOSA
Possible fines due to non-compliance
Damage to company reputation
Likelihood of review by governmental body
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Embase and Medical Devices
Medical device-specific indexing will help preparing for a clinical evaluation or doing post-market
surveillance to run more precise searches on the coverage of medical devices in the literature.
Device Search form
Device field limits
Device subheadings
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Track adverse effects and leverage comparison data
that’s unique to Embase
Subheadings let you search for a particular product, device type or class in relation to an adverse effect, a comparison, device economics or the mention of a clinical trial
Overlap with PubMed/MEDLINE quickly shows unique content
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Indexing and filters support comparison/competitive
analysis
Identify and group literature by class of devices and device types.
View all manufacturers and trade-names associated to that device class or type.
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Let’s take a look in
Embase…
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Indexing medical device items
1. All medical devices for which device-related information is given in the item are
indexed. To find medical devices, the whole record is read, including “materials
and methods”.
2. A medical device is indexed using the most specific term available in Emtree to
cover the device.
3. If an appropriate specific term to index the medical device is missing from
Emtree a new term (candidate term) is proposed/used.
4. Device trade names are index.
5. Device manufacturer names and country codes are indexed.
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Indexing medical device items (cont’)
device term medical device link linked disease term
hip prosthesis adverse device effect prosthesis loosening
hip prosthesis adverse device effect prosthesis infection
6. The appropriate medical device subheadings are indexed:
• Adverse device effect
• Device comparison
• Device economics
• Clinical trial
7. If medical device links are relevant, the appropriate device (triple) link/s are
indexed (triple-indexing).
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Indexing shows what’s relevant and what might be
missing…
Manufacturer Embase Not in MEDLINE
Abbott 6,503 1,283
Beckmann 9 2
Boston Scientific 10,212 1,854
Clearstream 7 1
Heartsine 7 1
Oceana Therapeutics 7 3
Merit 155 37
Sandoz 35 11
Siemens 24,046 3,583
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Clinical Evaluations –
Gather information for successful regulatory submissions
Potentially relevant
literature identified
Literature excluded,
with reasons
Literature excluded from clinical
evaluation, with reasons
Literature retrieved for
more detailed assessment
Literature with relevant useable data
included in the clinical evaluation: Device performance
Device safety
Device comparability
(if applicable)
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Scenario: device manufacturer wants to market a new vascular stent
Goal: Find critical information needed for successful regulatory
submissions (Clinical Evaluations and Post-Market Surveillance) that
includes:
• Device Performance
• Comparison of device with existing devices
• Device Safety – finding Adverse Device Effects
Demo
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Number of records on medical
devices indexed in Embase
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Clinical performance data
('vascular stent'/exp OR 'vascular stent‘ OR 'artery stent' OR
'endovascular stent' OR 'genesis stent' OR 'aortic aneurysm
endovascular graft' OR 'arterial stent' OR 'bioresorbable vascular
stent' OR 'stent retriever‘)
AND
([cochrane review]/lim OR [systematic review]/lim OR [controlled
clinical trial]/lim OR [randomized controlled trial]/lim OR [meta
analysis]/lim)
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Device comparison (subheading)
'vascular stent'/exp/dv_dc
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Safety data
'vascular stent'/exp/dv_am OR
(('vascular stent'/exp OR 'vascular stent‘ OR 'artery stent' OR
'endovascular stent' OR 'genesis stent' OR 'aortic aneurysm endovascular
graft' OR 'arterial stent' OR 'bioresorbable vascular stent' OR 'stent
retriever‘) AND ('adverse device effect'/lnk OR 'complication'/lnk OR
'postoperative complication'/exp OR (postoperative NEXT/2
complication*) OR (complicat* or 'risk'/exp or risks) OR ‘side effect’/exp
OR (adverse OR side OR undesirable OR lack) NEXT/2 effect*))
Quick search using subheadings:
'vascular stent'/exp/dv_am
Comprehensive search using subheadings and generic terms:
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In Conclusion
Feature Embase
Search for drug/device trade name
/manufacturer name
Search using Drug or Device Search form or use results filters
Subheadings: Adverse device effect,
Device comparison, Device economics,
Clinical Trial
Select these subheadings from the Device search form
Indexing Embase has more index terms (e.g., >102K records are indexed
with stent, and it includes several narrower terms)
Triple Indexing Only on Embase.com – For example, if search for Device
comparison, the medical devices being compared are shown. Same
with Adverse device effect (not relevant for economics or clinical
trials)
Medical device manufactures rely on scientific literature to:
• Design a unique product that meets key needs
• Inform reimbursement strategies
• Comply with pre- and post-market regulations
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• Q&A will be sent to you by email and for more information and
questions please contact your regional office
• Our next Embase webinar will take place June 24, 2015 and will
focus on how Embase and QUOSA are used in pharmacovigilance
as a literature monitoring solution.
• Please click on at Embase.com for Embase training materials,
including recordings of all archived webinars from 2014 and 2015
Thank you!
Please fill out the survey that appears on your
screen after leaving the webinar.
Thank you!
Contact:
Sherry Winter, PhD
Solution Marketing Manager
Ivan Krstic, PhD
Product Development Manager