A maximized sequential probability ratio test for drug and vaccine safety surveillance

Sequential Analysis

Volumn 30, Issue 1, 2011, Pages 58-78

  Kulldorff, Martin ^a   Davis, Robert L ^b   Kolczak, Margarette ^c   Lewis, Edwin ^d   Lieu, Tracy ^a   Platt, Richard ^a  

^a HARVARD PILGRIM HEALTH CARE   (United States)

^b KAISER PERMANENTE   (United States)

^c CENTERS FOR DIS CONTR AND PREV   (United States)

^d DIVISION OF RESEARCH   (United States)

Author keywords

Drug safety; Pharmacovigilance; Rapid cycle analysis; Sequential analysis; Surveillance

Indexed keywords

EID: 78751631255     PISSN: 07474946     EISSN: 15324176     Source Type: Journal    
DOI: 10.1080/07474946.2011.539924     Document Type: Article

References (40)

1. Abt, K. (1998). Poisson Sequential Sampling Modified Towards Maximal Safety in Adverse Event Monitoring, Biometrical Journal 40: 21-41.
2. Bangdiwala, S. I. (1982). A Sequential Likelihood Ratio Test for General Hypotheses, Sequential Analysis 1: 57-80.
3. Belongia, E. A., Irving, S. A., Shui, I. M., Kulldorff, M., Lewis, E., Yin, R., Lieu, T. A., Weintraub, E., Yih, W. K., Li, R., Baggs, J., and the Vaccine Safety Datalink Investigation Group (2010). Real-Time Surveillance to Assess Risk of Intussusception and Other Adverse Events after Pentavalent, Bovine-Derived Rotavirus Vaccine, Pediatric Infectious Disease Journal 29: 1-5.
4. Brown, J. S., Kulldorff, M., Chan, K. A., Davis, R. L., Graham, D., Pettus, P. T., Andrade, S. E., Raebel, M. A., Herrinton, L., Roblin, D., Boudreau, D., Smith, D., Gurwitz, J. H., Gunter, M. J., and Platt, R. (2007). Early Detection of Adverse Drug Events within Population-Based Health Networks: Application of Sequential Testing Methods, Pharmacoepidemiology and Drug Safety 16: 1275-1284.
5. Chen, R. T., Glasser, J. W., Rhodes, P. H., Davis, R. L., Barlow, W. E., Thompson, R. S., Mullooloy, J. P., Black, S. B., Shinefield, H. R., Vadheim, C. M., Marcy, S. M., Ward, J. I., Wise, R. P., Wassilak, S. G., Hadler, S. C., and the Vaccine Safety Datalink Team (1997). Vaccine Safety Datalink Project: A New Tool for Improving Vaccine Safety Monitoring in the United States, Pediatrics 99: 765-773.
6. Davis, R. L., Kolczak, M., Lewis, E., Nordin, J., Goodman, M., Shay, D. K., Platt, R., Black, S., Shinefield, H., and Chen, R. T. (2005). Active Surveillance of Vaccine Safety: A System to Detect Early Signs of Adverse Events, Epidemiology 16: 336-341.
7. DuMouchel, W. (1999). Bayesian Data Mining in Large Scale Frequency Tables, with an Application to the FDA Spontaneous Reporting System, American Statistician 53: 177-190.
8. Ghosh, B. K. (1965). Sequential Range Tests for Components of Variance, Journal of American Statistical Association 60: 826-836.
9. Ghosh, B. K. (1970). Sequential Tests for Statistical Hypothese, Reading, MA: Addison- Wesley.
10. Ghosh, M., Mukhopadhyay, N., and Sen, P. K. (1997). Sequential Estimation, New York: Wiley.
11. Govindarajulu, Z. (2004). Sequential Statistics, Singapore: World Scientific Publishing Company.
12. Hoel, D. G., Weiss, G. H., and Simon, R. (1976). Sequential Tests for Composite Hypotheses with Two Binomial Populations, Journal of the Royal Statistical Society B38: 302-308.
13. Holm, S. (1985). On the Optimality of Differentiated SPR Tests of Composite Hypotheses, Metrika 32: 15-33.
14. Huang, W. (2004). Stepwise Likelihood Ratio Statistics in Sequential Studies, Journal of Royal Statistical Society B66: 401-409.
15. Jennison, C. and Turnbull, B. W. (2000). Group Sequential Methods with Applications to Clinical Trials, Boca Raton, FL: Chapman and Hall/CRC.
16. Joanes, D. N. (1972). Sequential Tests of Composite Hypotheses, Biometrika 59: 633-637.
17. Klein, N. P., Fireman, B., Yih, W. K., Lewis, E., Kulldorff, M., Ray, P., Baxter, R., Hambidge, S., Nordin, J., Naleway, A., Belongia, E. A., Lieu, T., Baggs, J., and Weintraub, E., for the Vaccine Safety Datalink (2010). Measles-Mumps-Rubella- Varicella Combination Vaccine and the Risk of Febrile Seizures, Pediatrics 126: e1-e8.
18. Lachin, J. M. (1981). Sequential Clinical Trials for Normal Variates Using Interval Composite Hypotheses, Biometrics 37: 87-101.
19. Lai, T. L. (1988). Nearly Optimal Sequential Tests of Composite Hypotheses, Annals of Statistics 16: 856-886.
20. Lai, T. L. (2001). Sequential Analysis: Some Classical Problems and New Challenges, Statistica Sinica 11: 303-351.
21. Lechner, J. A. (1962). Optimum Decision Procedures for a Poisson Process Parameter, Annals of Mathematical Statistics 33: 1384-1402.
22. Lehmann, E. L. (1986). Testing Statistical Hypotheses, Second edition. New York: Springer- Verlag.
23. Lieu, T. A., Kulldorff, M., Davis, R. L., Lewis, E. M., Weintraub, E., Yih, K. W., Yin, R., Brown, J. S., and Platt, R. (2007). Real-Time Vaccine Safety Surveillance for the Early Detection of Adverse Events, Medical Care 45: S89-S95.
24. Lorden, G. (1973). Open-Ended Tests for Koopman-Darmois Families, Annals of Statistics 1: 633-643.
25. Meeker, W. Q. (1981). A Conditional Sequential Test for the Equality of Two Binomial Proportions, Applied Statistics 30: 109-115.
26. Mukhopadhyay, N. and de Silva, B. M. (2009). Sequential Methods and Their Applications, Boca Raton, FL: Chapman and Hall/CRC.
27. O'Neill, R. T. and Szarfman, A. (2001). Some U.S. Food and Drug Administration Perspectives on Data Mining for Pediatric Safety Assessment, Current Therapeutic Research 62: 650-663.
28. Partridge, A. and Yeh, S. H. (2003). Clinical Evaluation of a DTaP-HepB-IPV Combined Vaccine, American Journal of Managed Care 9: S13-S22.
29. Peskir, G. and Shiryaev, A. N. (2000). Sequential Testing Problems for Poisson Processes, Annals of Statistics 28: 837-859.
30. R Development Core Team. (2009). R: A Language and Environment for Statistical Computing, Vienna, Austria: R Foundation for Statistical Computing.
31. Schipper, M., den Hartog, J., and Meelis, E. (1997). Sequential Analysis of Environmental Monitoring Data: Optimal SPRTs, Environmetrics 8: 29-41.
32. Schwarz, G. (1962). Asymptotic Shape of Bayes Sequential Testing Regions, Annals of Mathematical Statistics 33: 224-236.
33. Siegmund, D. and Gregory, P. (1980). A Sequential Clinical Trial for Testing p1 = p2, Annals of Statistics 8: 1219-1228.
34. Szarfman, A., Machado, S. G., and O'Neill, R. T. (2002). Use of Screening Algorithms and Computer Systems to Efficiently Signal Higher-Than-Expected Combinations of Drugs and Events in the U.S. FDA's Spontaneous Reports Database, Drug Safety 25:381-392.
35. van der Tweel, I., Kaaks, R., and van Noord, P. A. H. (1996). Comparison of One-Sample Two-Sided Sequential t-Tests for Application in Epidemiological Studies, Statistics in Medicine 15: 2781-2795.
36. Wald, A. (1945). Sequential Tests of Statistical Hypotheses, Annals of Mathematical Statistics 16: 117-186.
37. Wald, A. (1947). Sequential Analysis, New York: Wiley.
38. Weiss, L. (1953). Testing One Simple Hypothesis Against Another, Annals of Mathematical Statistics 24: 273-281.
39. Woodroofe, M. (1978). Large Deviations of Likelihood Ratio Statistics with Applications to Sequential Testing, Annals of Statistics 6: 72-84.
40. Yih, W. K., Nordin, J. D., Kulldorff, M., Lewis, E., Lieu, T., Shi, P., and Weintraub, E. (2009). An Assessment of the Safety of Adolescent and Adult Tetanus-Diphtheria-Acellular Pertussis (Tdap) Vaccine, Using Active Surveillance for Adverse Events inthe Vaccine Safety Datalink, Vaccine 27: 4257-4262.