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Med dev webinar 27052015 total

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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-M...

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Webinar control panel:
• ‘Ask a question’ for
questions and comments
• Option for full screen view
• Q&A at the end
Ne...

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Med dev webinar 27052015 total

  1. 1. 1 Finding the right Medical Device information in Embase Presented by Sherry Winter and Ivan Krstic May 27, 2015
  2. 2. | 2 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
  3. 3. | 3 Webinar control panel: • ‘Ask a question’ for questions and comments • Option for full screen view • Q&A at the end Need to Know
  4. 4. | 4 • 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?
  5. 5. How does Embase support Medical Device research?
  6. 6. 6 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
  7. 7. | 7 Post-market surveillance – Companies face growing regulatory pressure
  8. 8. | 8 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
  9. 9. | 9 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
  10. 10. | 10 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
  11. 11. | 11 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 1
  12. 12. 12 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.
  13. 13. 13 Let’s take a look in Embase…
  14. 14. 14 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.
  15. 15. 15 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).
  16. 16. 16 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
  17. 17. 17
  18. 18. 18 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)
  19. 19. 19 | 19 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
  20. 20. 20 Number of records on medical devices indexed in Embase
  21. 21. 21 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)
  22. 22. 22 Device comparison (subheading) 'vascular stent'/exp/dv_dc
  23. 23. 23 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:
  24. 24. | 24 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
  25. 25. | 25 • 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.
  26. 26. Thank you! Contact: Sherry Winter, PhD Solution Marketing Manager s.winter.1@elsevier.com Ivan Krstic, PhD Product Development Manager i.krstic@elsevier.com

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