Statistical performance of group sequential methods for observational post-licensure medical product safety surveillance: A simulation study
暂无分享,去创建一个
Jennifer C. Nelson | Andrea J. Cook | Lisa A. Jackson | Shanshan Zhao | J. Nelson | A. Cook | L. Jackson | Shanshan Zhao
[1] Lingling Li,et al. A conditional sequential sampling procedure for drug safety surveillance , 2009, Statistics in medicine.
[2] W Katherine Yih,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. , 2009, Vaccine.
[3] S. Emerson,et al. A Unifying Family of Group Sequential Test Designs , 1999, Biometrics.
[4] W Katherine Yih,et al. Real-Time Surveillance to Assess Risk of Intussusception and Other Adverse Events After Pentavalent, Bovine-Derived Rotavirus Vaccine , 2010, The Pediatric infectious disease journal.
[5] M. Kulldorff,et al. A Maximized Sequential Probability Ratio Test for Drug and Vaccine Safety Surveillance , 2011 .
[6] Anastasios A. Tsiatis,et al. Group sequential designs for one-sided and two-sided hypothesis testing with provision for early stopping in favor of the null hypothesis , 1994 .
[7] P. Armitage,et al. Repeated Significance Tests on Accumulating Data , 1969 .
[8] Robert L Davis,et al. Real-Time Vaccine Safety Surveillance for the Early Detection of Adverse Events , 2007, Medical care.
[9] Eric J Topol,et al. Failing the public health--rofecoxib, Merck, and the FDA. , 2004, The New England journal of medicine.
[10] S J Pocock,et al. Interim analyses for randomized clinical trials: the group sequential approach. , 1982, Biometrics.
[11] R. Platt,et al. Developing the Sentinel System--a national resource for evidence development. , 2011, The New England journal of medicine.
[12] B W Turnbull,et al. Group sequential tests for bivariate response: interim analyses of clinical trials with both efficacy and safety endpoints. , 1993, Biometrics.
[13] T R Fleming,et al. Symmetric group sequential test designs. , 1989, Biometrics.
[14] P. O'Brien,et al. A multiple testing procedure for clinical trials. , 1979, Biometrics.
[15] R. Khan,et al. Sequential Tests of Statistical Hypotheses. , 1972 .
[16] T. Lai,et al. Sequential generalized likelihood ratio tests for vaccine safety evaluation , 2010, Statistics in medicine.
[17] Ruihua Yin,et al. Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project. , 2010, American journal of epidemiology.
[18] Tze Leung Lai,et al. Power, sample size and adaptation considerations in the design of group sequential clinical trials , 2003 .
[19] W Katherine Yih,et al. Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures , 2010, Pediatrics.
[20] Steven J. Jacobsen,et al. The Vaccine Safety Datalink: A Model for Monitoring Immunization Safety , 2011, Pediatrics.
[21] S. Pocock. Group sequential methods in the design and analysis of clinical trials , 1977 .