Using Oracle Empirica Topics to Document Your Signal Management Process
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This document discusses using Oracle's Empirica Topics software to document a company's signal management process. It describes how Empirica can be used for signal detection, prioritization, and evaluation. It also introduces the Accel-Tracker system, which configures Empirica with predefined workflows and questions to standardize the signal management process according to industry guidelines. Using Accel-Tracker allows automated documentation of a company's due diligence for auditing purposes.
Using Oracle Empirica Topics to Document Your Signal Management Process
- 1. Using Oracle's Empirica Topics to Document Your Signal Management Process November 01, 2012 Rodney Lemery, MPH, PhD Vice President, Safety and Pharmacovigilance BioPharm Systems, Inc. PREVIOUS PREVIOUS NEXT NEXT
- 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. Detailed Signal Management Process Signal Detection Signal Prioritization Signal Evaluation PREVIOUS 3 NEXT
- 4. Signal Management • The process of identifying, prioritizing and evaluating determined signals in a data population PREVIOUS NEXT
- 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. 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. 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. 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. 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. Signal Detection Example • In this example, we see an EBGM of ~9.7 in an interesting SOC PREVIOUS NEXT
- 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. 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. 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. 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. Accel-Tracker PREVIOUS NEXT
- 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. Accel-Tracker PREVIOUS NEXT
- 18. Accel-Tracker —Additional external documentation can also be attached to the topic to support the prioritization of the signal PREVIOUS NEXT
- 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. 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. 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. Accel-Tracker —Additional external documentati on can also be attached to the topic to support the evaluation of the signal PREVIOUS NEXT
- 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. 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. Accel-Tracker —Complete auditing of the topic case PREVIOUS NEXT
- 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. 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. 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. 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