Below are various active surveillance resources. If you would like to add a resource or event, please contact OMOP.
WEBSITE LINKS
• Food and Drug Administration Amendments Act (FDAAA)
• Mini-Sentinel
• FDA Sentinel Initiative
• Vaccine Safety Datalink (VSD)
• Exploring & Understanding Adverse Drug Reactions (EU-ADR)
• Drug Safety and Effectiveness Network (DSEN)
• Innovative Medicines Initiative - Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (IMI-PROTECT)
• Brookings activities on active medical product surveillance. Washington, DC: Brookings Institution.
PUBLICATIONS & PRESENTATIONS OF INTEREST
Behrman RE, Benner JS, Brown JS, McClellan M, Woodcock J, Platt R. Developing the Sentinel System - A national resource for evidence development. N Engl J Med 2011;364:498-499
Coloma PM, Schuemie MJ, Trifiro G. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiology and Drug Safety 2011; 20: 1-11
Brookhart, M.A., Sturmer, T., Glynn, R.J., Rassen, J., and Schneeweiss, S. (2010). Confounding control in healthcare database research: challenges and potential approaches. Medical Care, 48, S114-S120.
Brown JS, Holmes JH, Shah K, Hall K, Lazarus R, Platt R. Distributed health data networks: a practical and preferred approach to multi-institutional evaluations of comparative effectiveness, safety, and quality of care. Med Care 2010;48:Suppl:S45-S51
Caster, O., Noren, G. N., Madigan, D., and Bate, A. (2010). Large-Scale Regression-Based Pattern Discovery: The Example of Screening the WHO Global Drug Safety Database. Statistical Anaysis and Data Mining, 3, 197-208.
Brown, J. S., M. Kulldor , et al. (2009). Early adverse drug event signal detection within population-based health networks using sequential methods: key methodologic considerations. Pharmacoepidemiology and Drug Safety DOI: 10.1002/pds.1706.
Li, L. (2009). A conditional sequential sampling procedure for drug safety surveillance. Statistics in Medicine. DOI:10.1002/sim.3689
Platt R, Wilson M, Chan KA, Benner JS, Marchibroda J, McClellan M. The new Sentinel Network -- improving the evidence of medical-product safety. N Engl J Med 2009;361:645-647
Curtis JR, Cheng H, Delzell E, Fram D, Kilgore M, Saag K, Yun H and DuMouchel W. (2008). Adaptation of Bayesian data mining algorithms to longitudinal claims data. Medical Care, 46, 969-975.
Jin, H., Chen, J., He, H., Williams, G.J., Kelman, C., and O Keefe, C.M. (2008). Mining unexpected temporal associations: Applications in detecting adverse drug reactions. IEEE Transactions on Information Technology in Biomedicine, 12, 488-500.
Noren, G. N., Bate, A., Hopstadius, J., Star, K., and Edwards, I. R. (2008). Temporal pattern discovery for trends and transient e ects: its application to patient records. In: Proceedings of the Fourteenth International Conference on Knowledge Discovery and Data Mining SIGKDD 2008, 963-971.
Lieu TA, Kulldor M, Davis RL, Lewis EM, Weintraub E, Yih K, Yin R, Brown JS, and Platt R. (2007). Real-time vaccine safety surveillance for the early detection of adverse events. Medical Care, 45, S89-95.
UPCOMING EVENTS
April 2012
• ISPE Mid-Year - April 21-23, 2012, Eden Rock Hotel Miami Beach, FL
June 2012
• DIA 48th Annual Meeting - June 24-28, 2012, Philadelphia, PA