<ul><li>Signal Detection with Oracle Products </li></ul><ul><li>Presented By  </li></ul><ul><li>Dipti Kadam </li></ul><ul>...
<ul><li>My sincere thanks to Oracle Team for the information provided on the Oracle products </li></ul><ul><li>Organizers ...
Assumptions/Scope/Disclaimer <ul><li>Scope: Context is within the Oracle ARGUS Perceptive/ARGUS Insight </li></ul><ul><li>...
Agenda <ul><li>Background: What is Signal Detection? </li></ul><ul><li>Oracle Products for signal detection </li></ul><ul>...
Background: What is Signal Detection?  <ul><li>A process for identifying trends and correlations between Adverse Events an...
<ul><li>Usually, comparisons are made between existing known AEs and drug interactions, to determine if the AEs currently ...
What is Signal Detection? (3) <ul><li>To determine whether or not a Signal is valid, a threshold must be defined.  This is...
What is Signal Detection? (4) <ul><li>There are many types of statistical models which are used in Signal Detection analys...
Status of Signal Detection in Past, Today and Future ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Proh...
Oracle Products for Signal Detection ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
Overview of Argus Perceptive <ul><li>Assessor’s workflow separate from case processing </li></ul><ul><li>Automated Signal ...
Overview of Argus Perceptive <ul><li>Dynamic Workflow </li></ul><ul><ul><li>Flexible enough to fit any risk management bus...
Overview of Argus Perceptive <ul><li>Insight Linkage </li></ul><ul><ul><li>Passing the event level details to Insight in p...
Overview of Argus Perceptive ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited <ul><li>Where do ...
Overview of Argus Perceptive <ul><li>Where do alerts come from? </li></ul><ul><li>Primary alerts based on- </li></ul><ul><...
Overview of Argus Perceptive ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited <ul><li>Analytica...
Overview of Argus Perceptive ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited <ul><li>The Role ...
Signal Detection workflow ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Cases received Alert...
Overview of Argus Insight <ul><li>Oracle Argus Perceptive when integrated with Argus Insight, builds on a comprehensive sa...
Overview of Argus Insight 6 ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited <ul><li>Query Capa...
Conceptual Overview of Argus Insight ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
ARGUS Insight - Query abilities ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
ARGUS Insignt – Case series ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
ARGUS Insight –  Reports Library : Management ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
ARGUS Insight –  Reports Library : Pharmacovigilance ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Proh...
ARGUS Insight –  Reports Library : Pharmacovigilance ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Proh...
ARGUS Insight –  Reports Library : Compliance ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
Argus Insight –  Reports Library : Compliance ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
Argus Insight - Dashboards ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
<ul><li>Questions? </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
<ul><ul><ul><ul><ul><li>Thank you </li></ul></ul></ul></ul></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is St...
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Signal Detection With Oracle Products by Dipti Kadam, DBMS Consulting

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  • ©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited CTMS – Managing Site Data and Visit Tracking
  • ©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
  • ©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
  • ©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
  • ©2009 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
  • Transcript of "Signal Detection With Oracle Products by Dipti Kadam, DBMS Consulting"

    1. 1. <ul><li>Signal Detection with Oracle Products </li></ul><ul><li>Presented By </li></ul><ul><li>Dipti Kadam </li></ul><ul><li>[email_address] </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    2. 2. <ul><li>My sincere thanks to Oracle Team for the information provided on the Oracle products </li></ul><ul><li>Organizers for this opportunity </li></ul><ul><li>Thanks to the audience members for attending. </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Acknowledgements
    3. 3. Assumptions/Scope/Disclaimer <ul><li>Scope: Context is within the Oracle ARGUS Perceptive/ARGUS Insight </li></ul><ul><li>Assumption: audience is familiar with ARGUS SAFETY and its basic functionality </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    4. 4. Agenda <ul><li>Background: What is Signal Detection? </li></ul><ul><li>Oracle Products for signal detection </li></ul><ul><li>Signal Detection in past, today and future </li></ul><ul><li>Overview of ARGUS Perceptive </li></ul><ul><li>Overview of ARGUS Insight </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    5. 5. Background: What is Signal Detection? <ul><li>A process for identifying trends and correlations between Adverse Events and Drugs causing these AEs. </li></ul><ul><li>The concept is to monitor AEs which occur coincidentally and those which are actually related to the treatment or medication being provided. </li></ul><ul><li>WHO defines a pharmacovigilance signal as “reported information on a possible causal association between an adverse event and a drug, the relationship being unclear or incompletely documented previously”.   </li></ul><ul><li>A Safety signal refers to a concern about an apparent excess of adverse events compared to what would be expected. </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    6. 6. <ul><li>Usually, comparisons are made between existing known AEs and drug interactions, to determine if the AEs currently being reported are statistically significant </li></ul><ul><ul><li>Well known databases of AE to Drug interactions are kept by the FDA, WHO and several other EU countries. </li></ul></ul><ul><ul><li>These databases are generally made available for research and for Signal Detection purposes. </li></ul></ul><ul><li>As Signals are discovered, they must be analyzed to determine whether it represents a potential safety risk. This analysis can include: </li></ul><ul><ul><li>Causality </li></ul></ul><ul><ul><li>Frequency </li></ul></ul><ul><ul><li>Specificity vs. Sensitivity </li></ul></ul>Background: What is Signal Detection? (2) ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    7. 7. What is Signal Detection? (3) <ul><li>To determine whether or not a Signal is valid, a threshold must be defined. This is a mathematical formula to determine whether or not an AE should be counted as part of a Signal. </li></ul><ul><li>The analysis of the AE data and its comparison to other known comparative AE groups, along with the application of the threshold criteria is a sophisticated statistical modeling exercise </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    8. 8. What is Signal Detection? (4) <ul><li>There are many types of statistical models which are used in Signal Detection analysis, but three of the most common are: </li></ul><ul><li>Due to the numbers of Adverse Event reports and the volume of the comparison reference data, some analytical method is required. Manual comparison is not feasible. </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    9. 9. Status of Signal Detection in Past, Today and Future ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    10. 10. Oracle Products for Signal Detection ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    11. 11. Overview of Argus Perceptive <ul><li>Assessor’s workflow separate from case processing </li></ul><ul><li>Automated Signal Detection </li></ul><ul><li>Analytical tools for signaling, hypothesis testing & strengthening. </li></ul><ul><li>Searchable knowledgebase & repository </li></ul><ul><li>Event watch list management </li></ul><ul><li>Signal workup document preparation environment </li></ul><ul><li>Multiple levels of escalation & notifications </li></ul><ul><li>Management monitoring tools & reports </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    12. 12. Overview of Argus Perceptive <ul><li>Dynamic Workflow </li></ul><ul><ul><li>Flexible enough to fit any risk management business process </li></ul></ul><ul><li>Enhanced algorithms- more choice for alerting </li></ul><ul><ul><li>PRR </li></ul></ul><ul><ul><li>Chi square </li></ul></ul><ul><ul><li>Case scoring </li></ul></ul><ul><li>Worklists </li></ul><ul><ul><li>Easier differentiation of active/archive & watchlisted alerts </li></ul></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    13. 13. Overview of Argus Perceptive <ul><li>Insight Linkage </li></ul><ul><ul><li>Passing the event level details to Insight in preparation for more event driven reporting & querying </li></ul></ul><ul><li>Primary / Secondary separation </li></ul><ul><ul><li>Monitored / Ad hoc vs. mined </li></ul></ul><ul><li>Linked alerts </li></ul><ul><li>Support for Signal W orkup D ocument- regulatory reporting </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    14. 14. Overview of Argus Perceptive ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited <ul><li>Where do alerts come from? </li></ul><ul><li>Argus perspective </li></ul><ul><ul><li>Primary Alerts </li></ul></ul><ul><ul><li>Secondary Alerts </li></ul></ul>
    15. 15. Overview of Argus Perceptive <ul><li>Where do alerts come from? </li></ul><ul><li>Primary alerts based on- </li></ul><ul><ul><li>Designated Medical Events ( DME ) </li></ul></ul><ul><ul><li>Product Important Event ( PIE ) </li></ul></ul><ul><ul><li>Always Expeditable Events ( EXP ) </li></ul></ul><ul><ul><li>Serious Unlisted Events ( SUL ) </li></ul></ul><ul><ul><li>User Defined Alert type </li></ul></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    16. 16. Overview of Argus Perceptive ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited <ul><li>Analytical engines- Automatically invoked secondary alerts </li></ul><ul><ul><li>SAS stored processes ( e.g. PRR ) </li></ul></ul><ul><ul><li>Qscan </li></ul></ul><ul><ul><ul><li>Global view, Profiler </li></ul></ul></ul><ul><ul><ul><li>Logistic regression, Proportional analysis </li></ul></ul></ul><ul><ul><ul><li>Corelator, Comparator </li></ul></ul></ul><ul><ul><li>“ Native” capability </li></ul></ul><ul><li>Manually created alert via </li></ul><ul><ul><li>Argus safety </li></ul></ul><ul><ul><li>Argus insight </li></ul></ul><ul><ul><li>Qscan/SAS/Lincoln or other complimentary applications </li></ul></ul>
    17. 17. Overview of Argus Perceptive ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited <ul><li>The Role of Secondary Alerts </li></ul><ul><li>Directed Research and Hypothesis Generation </li></ul><ul><li>- Comparison to Expected Rates (e.g. disproportionality) </li></ul><ul><li>- Comparison of analytical measures across time </li></ul><ul><li>- Correlation with covariates (e.g. Drug-drug interaction) </li></ul><ul><li>- Comparison to other drug in drug class (e. g. FOI data) </li></ul><ul><li>- Comparison to pre-marketing data (Clinical trials data) </li></ul><ul><li>Data Mining </li></ul><ul><li>Generate a Case Series to process in Argus Perceptive </li></ul><ul><li>Generate Output (reports, Charts) for signal workups </li></ul>
    18. 18. Signal Detection workflow ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited Cases received Alert Triggered Surveillance scientist across worklist Surveillance scientist monitors alert and case series Surveillance scientist continues monitoring alert and no confirmed risk Escalation to Global safety scientist Global scientist access worklist Global scientist monitor alert/case series Push to Insight for analysis Take actions
    19. 19. Overview of Argus Insight <ul><li>Oracle Argus Perceptive when integrated with Argus Insight, builds on a comprehensive safety knowledge base can provide a proactive approach to risk management. </li></ul><ul><li>The analytical tools enable a real-time, auditable means for automated signal detection and further analysis and documentation. </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    20. 20. Overview of Argus Insight 6 ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited <ul><li>Query Capabilities </li></ul><ul><li>QBE </li></ul><ul><li>Filters </li></ul><ul><li>Advance Queries </li></ul><ul><li>Query Libraries </li></ul><ul><li>Report Writer </li></ul><ul><li>Ad hoc report output </li></ul><ul><li>Case Series </li></ul><ul><li>Report generation </li></ul><ul><li>Data Export </li></ul><ul><li>Can be saved for future use </li></ul><ul><li>Standard Reports </li></ul><ul><li>Pharmacovigilance </li></ul><ul><li>Management </li></ul><ul><li>Compliance </li></ul><ul><li>Configuration </li></ul><ul><li>CIOMS/Medwatch </li></ul><ul><li>Dashboard Indicators </li></ul><ul><li>Quick overview of certain key indicators </li></ul><ul><li>Cubes </li></ul><ul><li>Multidimential analysis tool with drill down capabilities </li></ul>
    21. 21. Conceptual Overview of Argus Insight ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    22. 22. ARGUS Insight - Query abilities ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    23. 23. ARGUS Insignt – Case series ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    24. 24. ARGUS Insight – Reports Library : Management ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    25. 25. ARGUS Insight – Reports Library : Pharmacovigilance ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    26. 26. ARGUS Insight – Reports Library : Pharmacovigilance ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    27. 27. ARGUS Insight – Reports Library : Compliance ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    28. 28. Argus Insight – Reports Library : Compliance ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    29. 29. Argus Insight - Dashboards ©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    30. 30. <ul><li>Questions? </li></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited
    31. 31. <ul><ul><ul><ul><ul><li>Thank you </li></ul></ul></ul></ul></ul>©2010 DBMS Consulting, Inc. Unauthorized Duplication is Strictly Prohibited

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