Using Oracles Empirica Topics to Document YourSignal Management Process                          November 01, 2012        ...
Agenda• Summary of Signal Management  CIOMS VIII Suggestions  Definitions• Signal Management using Oracle Empirica Produ...
Detailed Signal Management Process          Signal          Detection                                                Signa...
Signal Management•   The process of identifying, prioritizing and evaluating    determined signals in a data population   ...
Signal Detection•   The act of looking for and/or identifying signals using event    data from any source. (CIOMS, 2010 p....
What the Industry Seeks• A systematic approach to signal  management   Ability to identify potential issues in clinical a...
Accel-Tracker —Using the Empirica Suite (e-Signal and e-Topics) tool as the basic software,  BioPharm has created an accel...
Signal Detection•       The Empirica Suite contains the same signal detection tool (used        by the FDA) to identify po...
Signal Detection Example•   Assuming we are the marketing authorization holder for    the US-marketed product Risedronate ...
Signal Detection Example                           • In this                             example, we                      ...
Signal Prioritization•   The rapid review of SOC data from FDA/AERS seems to    indicate that we may have a signal for som...
Signal Prioritization•   Prioritization of signals is a critical aspect of signal    management when mining large reposito...
Signal Management Challenge: Where do we begin?• No real standard in the prioritization process (Waller, 2010, p.  50) —Th...
Accel-Tracker —Using the e-Topics tool as the basic software, BioPharm has created an  accelerator that allows a company t...
Accel-Tracker                PREVIOUS   NEXT
Accel-Tracker —Once the signal is placed into the initial Signal Prioritization step, the  Accel-Tracker system allows the...
Accel-Tracker                PREVIOUS   NEXT
Accel-Tracker —Additional  external  documentation  can also be  attached to the  topic to  support the  prioritization of...
Accel-Tracker                —Signals prioritized as                 High or Medium are                 moved into the Sig...
Accel-Tracker—Actions can be created and assigned to other users in the company—In this example, an action to review the c...
Accel-Tracker —Using e-Signal, we can drill  down into the case series  that makes up the signal of  interest             ...
Accel-Tracker —Additional  external  documentati  on can also  be attached  to the topic  to support  the  evaluation  of ...
Accel-Tracker —After research on the signal is collected, Accel-Tracker can document  the results of evaluation through th...
Accel-Tracker —Using the default abilities of e-Topics, we can run reports documenting  our signal management process at t...
Accel-Tracker —Complete auditing of the topic case                                        PREVIOUS   NEXT
Summary —Using existing literature and Empirica Suite, configured with the Accel-  Tracker settings, we can provide a syst...
Ways to Engage…• For those not quite ready… • Collaborate on requirements• For those in the midst of an e-Topics implement...
References•   Bennett Levitan, B., Yee, C. L., Russo,L., Bayney, R., Thomas, A. P. and Klincewicz, S.    L.. (2008). A Mod...
Questions & Answers                                 Rodney L. Lemery MPH, PhD                                 Vice Pres. S...
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Using Oracle Empirica Topics to Document Your Signal Management Process

  1. 1. Using Oracles Empirica Topics to Document YourSignal Management Process November 01, 2012 Rodney Lemery, MPH, PhD Vice President, Safety and Pharmacovigilance BioPharm Systems, Inc. PREVIOUS PREVIOUS NEXT NEXT
  2. 2. Agenda• Summary of Signal Management  CIOMS VIII Suggestions  Definitions• Signal Management using Oracle Empirica Products  Detection  Use of e-Signal for data mining  Prioritization  Accel-Tracker (Prioritization Workflow)  Evaluation  Accel-Tracker (Evaluation Workflow) PREVIOUS NEXT
  3. 3. Detailed Signal Management Process Signal Detection Signal Prioritization Signal Evaluation PREVIOUS 3 NEXT
  4. 4. Signal Management• The process of identifying, prioritizing and evaluating determined signals in a data population PREVIOUS NEXT
  5. 5. Signal Detection• The act of looking for and/or identifying signals using event data from any source. (CIOMS, 2010 p.116)Signal Prioritization• The controversial act of applying plausibility criteria to identified signals in order to place the signals in context and apply appropriate resources. (Waller, 2010 p.50)Signal Evaluation• The act of formally gathering additional data to evaluate the identified signal for the purpose of risk management. (Waller, 2010 p. 50,51) PREVIOUS NEXT
  6. 6. What the Industry Seeks• A systematic approach to signal management  Ability to identify potential issues in clinical and post- marketing data  Standard prioritization questions  Standard evaluation methods to feed risk management  Pre-defined workflow for these processes• A system to collect and track this approach  Standard system to document the identification, prioritization and evaluation of signals  Capability to report this process for audit answering and justification or risk methods (document due diligence) PREVIOUS NEXT
  7. 7. Accel-Tracker —Using the Empirica Suite (e-Signal and e-Topics) tool as the basic software, BioPharm has created an accelerator that allows a company to document the formal signal prioritization and evaluation methods suggested by the CIOMS VIII working group and a series of decision support articles from the literature —The following slides will walk us through a practical example of signal management, starting with signal identification and followed by signal prioritization and signal evaluation, resulting in risk identification/mitigation PREVIOUS NEXT
  8. 8. Signal Detection• The Empirica Suite contains the same signal detection tool (used by the FDA) to identify potential signals based on disproportionality reporting ratios• As we’ve seen above, the CIOMS VIII group recommends that signal management begins with signal detection • This can be either data mining large repositories or identification of cases or case series in traditional individual case safety review• While the process begins with signal detection of individual case safety reports, eventually the collected ICSRs become large enough for data mining techniques; the prioritization of the signals becomes an important aspect of signal management (Waller, 2010, p.50) 1. Ensures focus on appropriate signals – “Hay in a hay stack” 2. Focuses appropriate resource allocation time/energy/money PREVIOUS NEXT
  9. 9. Signal Detection Example• Assuming we are the marketing authorization holder for the US-marketed product Risedronate (Risedronic Acid) ▫ This is a bisphosphonate used in the treatment of degenerative bone disease. Its mode of action is the strengthening of bone as well as the inhibition of bone reabsorbtion. ▫ It was approved on March 27th, 1998 under the trade name “Actonel”• We can establish FDA/AERS queries in the e-Signal tool to identify “hot-spots” of the MedDRA dictionary levels PREVIOUS NEXT
  10. 10. Signal Detection Example • In this example, we see an EBGM of ~9.7 in an interesting SOC PREVIOUS NEXT
  11. 11. Signal Prioritization• The rapid review of SOC data from FDA/AERS seems to indicate that we may have a signal for some kind of degradation of the oral cavity warranting tooth extraction to correct. This signal may warrant further investigation, but we do not want to waste resources on the following:• Known issues with the product already well documented (expected events or well-established safety profiles)• Co-morbidities or complications due to natural disease progression - Disease states epidemiologically related to the treatment population without regard to product exposure (confounding by indication) PREVIOUS NEXT
  12. 12. Signal Prioritization• Prioritization of signals is a critical aspect of signal management when mining large repositories of data (Waller, 2010, p.50) 1. Simplifies the often daunting task of signal management 2. Focuses appropriate resource allocation time/energy/money PREVIOUS NEXT
  13. 13. Signal Management Challenge: Where do we begin?• No real standard in the prioritization process (Waller, 2010, p. 50) —The WHO uses a method similar to Emergency Room triage processes in hospital settings to quickly evaluate the aspects of a case that make it critical for research while placing other cases on hold until a later investigation period —The MHRA uses an analytic methodology comprised of two mathematical scores contributing to a final score that will prioritize the case —Other articles exist in the literature suggesting valid decision support methods PREVIOUS NEXT
  14. 14. Accel-Tracker —Using the e-Topics tool as the basic software, BioPharm has created an accelerator that allows a company to document the formal signal prioritization and evaluation methods suggested by the CIOMS VIII working group and a series of decision support articles from the literature —Once a signal is identified, a topic is created in e-Topics and assigned to the appropriate work-group in a standard workflow within the system PREVIOUS NEXT
  15. 15. Accel-Tracker PREVIOUS NEXT
  16. 16. Accel-Tracker —Once the signal is placed into the initial Signal Prioritization step, the Accel-Tracker system allows the formal prioritization, according to the CIOMS VIII methodology and a series of decision support articles in the literature —This is a series of questions that allow the categorization of the signal according to signal strength (S), novelty (N), clinical importance (I), potential for prevention techniques (P) (CIOMS, 2010; Heeley, Waller & Moseley, 2005; Waller, 2010; Waller, Heeley & Moseley, 2005; Waller & Lee, 1999) PREVIOUS NEXT
  17. 17. Accel-Tracker PREVIOUS NEXT
  18. 18. Accel-Tracker —Additional external documentation can also be attached to the topic to support the prioritization of the signal PREVIOUS NEXT
  19. 19. Accel-Tracker —Signals prioritized as High or Medium are moved into the Signal Evaluation workflow step for further investigation and signal workup PREVIOUS NEXT
  20. 20. Accel-Tracker—Actions can be created and assigned to other users in the company—In this example, an action to review the case series is assigned PREVIOUS NEXT
  21. 21. Accel-Tracker —Using e-Signal, we can drill down into the case series that makes up the signal of interest —The case series can be attached to the topic of interest for historical identification PREVIOUS NEXT
  22. 22. Accel-Tracker —Additional external documentati on can also be attached to the topic to support the evaluation of the signal PREVIOUS NEXT
  23. 23. Accel-Tracker —After research on the signal is collected, Accel-Tracker can document the results of evaluation through the exposure of several custom questions designed to assist in the formal evaluation of signals —The signal can be classified and optionally elevated to a Potential or Identified Risk to begin the Risk Analysis and Mitigation process PREVIOUS NEXT
  24. 24. Accel-Tracker —Using the default abilities of e-Topics, we can run reports documenting our signal management process at the request of a regulatory authority or equivalent PREVIOUS NEXT
  25. 25. Accel-Tracker —Complete auditing of the topic case PREVIOUS NEXT
  26. 26. Summary —Using existing literature and Empirica Suite, configured with the Accel- Tracker settings, we can provide a systematic method for signal management in a single solution that accomplishes the following: —Ability to identify potential issues in clinical and post-marketing data —Standard prioritization questions —Standard evaluation methods to feed risk management —Pre-defined workflow for these processes —Capability to report this process for audit answering and justification or risk methods (document due diligence) PREVIOUS NEXT
  27. 27. Ways to Engage…• For those not quite ready… • Collaborate on requirements• For those in the midst of an e-Topics implementation • Refine your approach with Accel-Tracker• In-depth system demonstration of Accel-Tracker• On-site proof of concept• Looking to harmonize relevant business processes? PREVIOUS NEXT
  28. 28. References• Bennett Levitan, B., Yee, C. L., Russo,L., Bayney, R., Thomas, A. P. and Klincewicz, S. L.. (2008). A Model for Decision Support in Signal Triage. Drug Safety. 31 (9), pp. 727-735• Council for International Organizations of Medical Sciences (CIOMS). (2010). Practical Aspects of Signal Detection in Pharmacovigilance. Report of CIOMS Working Group VIII, Geneva .• Heeley E, Waller P, and Moseley J. (2005). Testing and implementing signal impact analysis in a regulatory setting: results of a pilot study. Drug Safety 28 (10), pp. 901-6• Waller P, Heeley E, and Moseley J. (2005). Impact analysis of signals detected from spontaneous adverse drug reaction reporting. Drug Safety 28 (1), pp. 843-50• Waller P, Lee E. (1999). Responding to drug safety issues. Pharmacoepidemiology and Drug Safety 8 (7), pp. 535-52• Waller, P. (2010). An Introduction to Pharmacovigilance. Wiley-Blackwell. Oxford, UK PREVIOUS NEXT
  29. 29. Questions & Answers Rodney L. Lemery MPH, PhD Vice Pres. Safety and PV 2000 Alameda de las Pulgas Suite 154 Tel (650) 292-5310 San Mateo, CA 94403-1270 Fax (650) 292-5301 www.biopharm.com rlemery@biopharm.com PREVIOUS NEXT

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