Active Postmarketing Drug Surveillance for Multiple Adverse Events
Published Online:20 Nov 2015https://doi.org/10.1287/opre.2015.1435
References
- (1987) Diabetes and the risk of stroke: The Honolulu heart program. J. Amer. Med. Assoc. 257(7):949–952.Crossref, Google Scholar
- (1988) Diabetes mellitus: An independent risk factor for stroke? Amer. J. Epidemiol 128(1):116–123.Crossref, Google Scholar
- (1998) A Bayesian neural network method for adverse drug reaction signal generation. Eur. J. Clinical Pharmacology 54(4):315–321.Crossref, Google Scholar
- (2012) Lifetime risks of cardiovascular disease. New England J. Medicine 366(4):321–329.Crossref, Google Scholar
- (1999) Postmarketing surveillance and adverse drug reactions. J. Amer. Medicine Assoc. 281(9):824–829.Crossref, Google Scholar
- (2007) Early detection of adverse drug events within population-based health networks: Application of sequential testing methods. Pharmacoepidem Drug Safety 16(12):1275–1284.Crossref, Google Scholar
- (1972) Regression models and life-tables. J. Roy. Statist. Soc. Series B (Methodological) 34(2):187–220.Crossref, Google Scholar
- (2004) Gaps, tensions, and conflicts in the FDA approval process: Implications for clinical practice. J. Amer. Board Family Medicine 17(2):142–149.Crossref, Google Scholar
- (1999) Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Amer. Statistician 53(3):177–190.Google Scholar
- (1993) The physics of the Mt/G/∞ queue. Oper. Res. 41(4):731–742.Link, Google Scholar
- (2001) Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology Drug Safety 10(6):483–486.Crossref, Google Scholar
- FDA (2012) FDA’s Sentinel Initiative. Accessed April 10, 2012, http://www.fda.gov/Safety/FDAsSentinelInitiative/.Google Scholar
- (1999) Time-dependent covariates in the Cox proportional-hazards regression model. Annual Rev. Public Health 20(1):145–157.Crossref, Google Scholar
- (1993) Depression following myocardial infarction. J. Amer. Medicine Assoc. 270(15):1819–1825.Crossref, Google Scholar
- (2006) The FDA and drug safety: A proposal for sweeping changes. Arch. Intern. Medicine 166(18):1938–1942.Crossref, Google Scholar
- (2011) CVX: Matlab software for disciplined convex programming, version 1.21, http://cvxr.com/cvx.Google Scholar
- (1998) Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. New England J. Medicine 339(4):229–234.Crossref, Google Scholar
- (1997) Robustness of the exponential sequential probability ratio test (SPRT) when Weibull distributed failures are transformed using a “known” shape parameter. Microelectronics Reliability 37(12):1835–1840.Crossref, Google Scholar
- (1999) Group Sequential Methods with Applications to Clinical Trials (Chapman and Hall/CRC, Boca Raton, FL).Crossref, Google Scholar
- (1979) Diabetes and cardiovascular disease. J. Amer. Medicine Assoc. 241(19):2035.Crossref, Google Scholar
- (2010) Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures. Pediatrics 126(1):e1–e8.Crossref, Google Scholar
- (2011) A maximized sequential probability ratio test for drug and vaccine safety surveillance. Sequential Anal. 30(1):58–78.Crossref, Google Scholar
- (1991) Asymptotic optimality of generalized sequential likelihood ratio tests in some classical sequential testing procedures. Ghosh PKSBK, ed. Handbook of Sequential Analysis (Dekker, New York), 121–144.Google Scholar
- (2004) Power, sample size and adaptation considerations in the design of group sequential clinical trials. Biometrika 91(3):507–528.Crossref, Google Scholar
- (2007) Real-time vaccine safety surveillance for the early detection of adverse events. Medicine Care 45(10):S89–S95.Crossref, Google Scholar
- (2001) Diabetes mellitus and risk of Alzheimer’s disease and dementia with stroke in a multiethnic cohort. Amer. J. Epidemiol. 154(7):635–641.Crossref, Google Scholar
- (1991) A prospective study of maturity-onset diabetes mellitus and risk of coronary heart disease and stroke in women. Arch. Intern. Medicine 151(6):1141–1147.Crossref, Google Scholar
- (1993) Networks of infinite-server queues with nonstationary Poisson input. Queueing Systems 13(1–3):183–250.Crossref, Google Scholar
- (2007) Drug safety reform at the FDA pendulum swing or systematic improvement? New England J. Medicine 356(17):1700–1702.Crossref, Google Scholar
- (2009) Evaluation of signal detection methods for use in prospective post licensure medical product safety surveillance. FDA Sentinel Initiative Safety Signal Identification contract. Report, Food and Drug Administration, Washington, DC.Google Scholar
- (2010) On robustness of a sequential test for scale parameter of gamma and exponential distributions. Appl. Math. 1(4):274–278.Crossref, Google Scholar
- (2009) Quickest Detection (Cambridge University Press, New York).Google Scholar
- (1995) Multiple hypothesis testing. Annu. Rev. Psychol 46(1): 561–584.Crossref, Google Scholar
- (2010) Sequential generalized likelihood ratio tests for vaccine safety evaluation. Statist. Medicine 29(26):2698–2708.Crossref, Google Scholar
- (1985) Sequential Analysis: Tests and Confidence Intervals (Springer, New York).Crossref, Google Scholar
- (1999) SDPT3—A MATLAB software package for semidefinite programming, version 1.3. Optim. Method Software 11(1):545–581.Crossref, Google Scholar
- (2003) Solving semidefinite-quadratic-linear programs using SDPT3. Math. Program. 95(2):189–217.Crossref, Google Scholar
- (1998) Aging, health risks, and cumulative disability. New England J. Medicine 338(15):1035–1041.Crossref, Google Scholar
- (1945) Sequential tests of statistical hypotheses. Ann. Math. Stat. 16(2):117–186.Crossref, Google Scholar
- (1948) Optimum character of the sequential probability ratio test. Ann. Math. Stat. 19(3):326–339.Crossref, Google Scholar
- (2009) Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR* D report. Amer. J. Psychiatry 166(5):599.Crossref, Google Scholar
- (2009) 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 27(32):4257–4262.Crossref, Google Scholar

