Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data

Pharmacoepidemiology and Drug Safety

Volumn 21, Issue SUPPL. 1, 2012, Pages 62-71

  Nelson, Jennifer C ^a,b   Cook, Andrea J ^a,b   Yu, Onchee ^a   Dominguez, Clara ^a,b   Zhao, Shanshan ^a,b   Greene, Sharon K ^c   Fireman, Bruce H ^d   Jacobsen, Steven J ^e   Weintraub, Eric S ^f   Jackson, Lisa A ^a  

^a GROUP HEALTH RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c HARVARD MEDICAL SCHOOL   (United States)

^d DIVISION OF RESEARCH   (United States)

^e Kaiser Permanente Southern California ^*  (United States)

^f CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

Author keywords

Observational study; Pharmacovigilance; Postmarketing; Sequential testing; Study design; Vaccine and drug safety

Indexed keywords

ARTICLE; CLINICAL EFFECTIVENESS; DATA PROCESSING; DRUG MONITORING; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; ERROR; HUMAN; OBSERVATIONAL STUDY; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PREVALENCE; PRIORITY JOURNAL; PRIVACY; PROCESS DESIGN; PROCESS MONITORING; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; SEQUENTIAL ANALYSIS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CONFOUNDING FACTORS (EPIDEMIOLOGY); DATABASES, FACTUAL; ELECTRONIC HEALTH RECORDS; EPIDEMIOLOGIC RESEARCH DESIGN; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; VACCINES;

EID: 84856027979     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2324     Document Type: Article

References (32)

1. Chen RT, DeStefano F, Davis RL, et al. The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA. Bull World Health Organ 2000; 78(2): 186-194.
2. Davis RL, Kolczak M, Lewis E, et al. Active surveillance of vaccine safety: a system to detect early signs of adverse events. Epidemiology 2005; 16: 336-341. DOI: 10.1097/01.ede.0000155506.05636.a4
3. Baggs J, Gee J, Lewis E, et al. The Vaccine Safety Datalink: a model for monitoring immunization safety. Pediatrics 2011; 127: S45-S53.
4. Behrman RE, Benner JS, Brown JS, et al. Developing the Sentinel System - A National Resource for Evidence Development. N Engl J Med 2011; 364: 498-499.
5. Nelson JC, Cook AJ, Yu O, et al. Methods for observational post-licensure medical product safety surveillance. Stat Methods Med Res (in press).
6. Kulldorff M, Davis RL, Kolczak M, et al. A maximized sequential probability ratio test for drug and vaccine safety surveillance. Seq Anal 2011; 30: 58-78.
7. Lieu TA, Kulldorff M, Davis RL, et al. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care 2007; 45(10): S89-95. DOI: 10.1097/MLR.0b013e3180616c0a
8. Yih WK, Nordin JD, Kulldorff M, et al. An assessment of the safety of adolescent and adult tetanus-diphtheria-acellular pertussis (Tdap) vaccine, using active surveillance for adverse events in the Vaccine Safety Datalink. Vaccine 2009; 27: 4257-4262. DOI: 10.1016/j.vaccine.2009.05.036
9. Belongia EA, Irving S, Shui IM, et al. on behalf of the Vaccine Safety Datalink Investigation Group. Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine. Pediatr Infect Dis J 2010; 29(1): 1-5. DOI: 10.1097/INF.0b013e3181af8605
10. Klein NP, Fireman B, Yih WK, et al. Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures. Pediatrics 2010; 126: e1-e8. DOI: 10.1542/peds.2010-0665
11. Greene SK, Kulldorff M, Lewis EM, et al. Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project. Am J Epidemiol 2010; 171(2): 177-88. DOI: 10.1093/aje/kwp345
12. Klein NP, Yih WK, Marin M, et al. Update: Recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding administration of combination MMRV vaccine. MMWR Morb Mortal Wkly Rep 2008; 57: 258-260.
13. Lee GM, Greene SK, Weintraub ES, et al. on behalf of the Vaccine Safety Datalink Project. H1N1 and seasonal influenza vaccine safety using prospective weekly surveillance in the Vaccine Safety Datalink Project. Am J Prev Med 2011; 41: 121-128.
14. Whitehead J. The design and analysis of sequential clinical trials. Wiley: New York, NY, 1997.
15. Jennison C, Turnbull BW. Group sequential methods with applications to clinical trials. CRC Press: Boca Raton, FL, 2000.
16. Li L. A conditional sequential sampling procedure for drug safety surveillance. Stat Med 2009; 28: 3124-3138. DOI: 10.1002/sim.3689
17. Cook AJ, Tiwari RC, Wellman RD, et al. Statistical approaches to group sequential monitoring of postmarketing safety surveillance data: Current state of the art for use in the Mini-Sentinel surveillance project. Pharmacoepidemiol Drug Saf 2012; 21(S1): 72-81.
18. Centers for Disease Control and Prevention. Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, and Haemophilus b Conjugate Vaccine and Guidance for Use in Infants and Children. MMWR Morb Mortal Wkly Rep 2008; 57(39): 1079-1080.
19. Brown JS, Kulldorff M, Chan KA, et al. Early detection of adverse drug events within population-based health networks: application of sequential testing methods. Pharmacoepidemiol Drug Saf 2007; 16(12): 1275-1284. DOI: 10.1002/pds.1509
20. Brown JS, Kulldorff M, Petronis KR, et al. Early adverse drug event signal detection within population-based health networks using sequential methods: key methodologic considerations. Pharmacoepidemiol Drug Saf 2009; 18(3): 226-234. DOI: 10.1002/pds.1706
21. Emerson SS, Kittelson JM, Gillen DL. Frequentist evaluation of group sequential clinical trial designs. Stat Med 2007; 26: 5047-5080. DOI: 10.1002/sim.2901
22. Gagne JJ, Fireman B, Ryan PB, et al. Study design considerations in an active medical product safety monitoring system. Pharmacoepidemiol Drug Saf 2012; 21(S1): 32-40.
23. Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika 1977; 64(2): 191-199. DOI: 10.1093/biomet/64.2.191
24. Whitehead J, Stratton I. Group Sequential Clinical Trials with Triangular Continuation Regions. Biometrics 1983; 39: 227-236.
25. O'Brien PC, Fleming TR. A Multiple Testing Procedure for Clinical Trials. Biometrics 1979; 35: 549-556.
26. Wang SK, Tsiatis AA. Approximately Optimal One-Parameter Boundaries for Group Sequential Trials. Biometrics 1987; 43: 193-199.
27. Kittelson JM, Emerson SS. A unifying family of group sequential test designs. Biometrics 1999; 55(3): 874-882.
28. Burington BE, Emerson SS. Flexible implementations of group sequential stopping rules using constrained boundaries. Biometrics 2003; 59(4): 770-777.
29. Food and Drug Administration. Product information: package insert. Pentacel (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate [tetanus toxoid conjugate] vaccine. [29 January 2007].
30. Guerra FA, Blatter MM, Greenberg DP, et al. on behalf of the Pentacel Study Group. Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: A randomized, clinical trial. Pediatrics 2009; 123: 301-312. DOI: 10.1542/peds.2007-3317
31. Greene SK, Kulldorff M, Yin R, et al. Near real-time vaccine safety surveillance with partially accrued data. Pharmacoepidemiol Drug Saf 2011; 20(6): 583-590.
32. Lan KKG, Demets DL. Discrete Sequential Boundaries for Clinical-Trials. Biometrika 1983; 70(3): 659-663.