Resources for Active Surveillance

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

The Sentinel Initiative: Access to Electronic Healthcare Data for More than 25 Million Lives, Achieving FDAAA Section 905 Goal One, July 2010

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.

The Sentinel Initiative: National Strategy for Monitoring Medical Product Safety. Silver Spring, MD: Food and Drug Administration, May 2008

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