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Callegaro, Andrea; Zahaf, Toufik; Tibaldi, Fabian

Assurance in vaccine efficacy clinical trial design based on immunological responses. (English) Zbl 1523.62095

Biom. J. 63, No. 7, 1434-1443 (2021).

MSC:

62P10 Applications of statistics to biology and medical sciences; meta analysis

Keywords:

assurance; Bayesian analysis; correlate of risk model; decision-making; expected power; predictions; probability of success; surrogate endpoint; vaccine efficacy; vaccine trials
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[1] Baker, S. G., & Kramer, B. S. (2003). A perfect correlate does not a surrogate make. BMC Medical Research Methodology, 3(1), 1-5.
[2] Burzykowski, T., Molenberghs, G., & Buyse, M. (2005). The evaluation of surrogate endpoints. Springer Science+Business Media. · Zbl 1078.62113
[3] Buyse, M., Molenberghs, G., Burzykowski, T., Renard, D., & Geys, H. (2000). The validation of surrogate endpoints in meta‐analyses of randomized experiments. Biostatistics, 1(1), 49-67. · Zbl 1122.62339
[4] Callegaro, A., & Tibaldi, F. (2019). Assessing correlates of protection in vaccine trials: Statistical solutions in the context of high vaccine efficacy. BMC Medical Research Methodology, 19(1), 1-7.
[5] Carroll, K. J. (2013). Decision making from phase II to phase III and the probability of success: Reassured by “assurance”?Journal of Biopharmaceutical Statistics, 23(5), 1188-1200.
[6] Chan, I. S., Li, S., Matthews, H., Chan, C., Vessey, R., Sadoff, J., et al. (2002). Use of statistical models for evaluating antibody response as a correlate of protection against varicella. Statistics in Medicine, 21(22), 3411-3430.
[7] Dallow, N., Best, N., & Montague, T. H. (2018). Better decision making in drug development through adoption of formal prior elicitation. Pharmaceutical Statistics, 17(4), 301-316.
[8] Dunning, A. J. (2006). A model for immunological correlates of protection. Statistics in Medicine, 25(9), 1485-1497.
[9] Dunning, A. J., Kensler, J., Coudeville, L., & Bailleux, F. (2015). Some extensions in continuous models for immunological correlates of protection. BMC Medical Research Methodology, 15(1), 107.
[10] Follmann, D. (2006). Augmented designs to assess immune response in vaccine trials. Biometrics, 62(4), 1161-1169. · Zbl 1114.62116
[11] Freedman, L. S., Graubard, B. I., & Schatzkin, A. (1992). Statistical validation of intermediate endpoints for chronic diseases. Statistics in Medicine, 11(2), 167-178.
[12] Gilbert, P. B., Qin, L., & Self, S. G. (2008). Evaluating a surrogate endpoint at three levels, with application to vaccine development. Statistics in Medicine, 27(23), 4758-4778.
[13] Gillett, R. (1994). An average power criterion for sample size estimation. The Statistician, 43, 389-394.
[14] Ibrahim, J. G., Chen, M. H., Lakshminarayanan, M., Liu, G. F., & Heyse, J. F. (2015). Bayesian probability of success for clinical trials using historical data. Statistics in Medicine, 34(2), 249-264.
[15] Katz, D., Baptista, J., Azen, S. P., & Pike, M. C. (1978). Obtaining confidence intervals for the risk ratio in cohort studies. Biometrics, 34, 469-474.
[16] Korn, E. L., Albert, P. S., & McShane, L. M. (2005). Assessing surrogates as trial endpoints using mixed models. Statistics in Medicine, 24(2), 163-182.
[17] O’Hagan, A., Stevens, J. W., & Campbell, M. J. (2005). Assurance in clinical trial design. Pharmaceutical Statistics, 4(3), 187-201.
[18] Prentice, R. L. (1989). Surrogate endpoints in clinical trials: Definition and operational criteria. Statistics in Medicine, 8(4), 431-440.
[19] Qin, L., Gilbert, P. B., Corey, L., McElrath, M. J., & Self, S. G. (2007). A framework for assessing immunological correlates of protection in vaccine trials. Journal of Infectious Diseases, 196(9), 1304-1312.
[20] Saint-Hilary, G., Barboux, V., Pannaux, M., Gasparini, M., Robert, V., & Mastrantonio, G. (2019). Predictive probability of success using surrogate endpoints. Statistics in Medicine, 38(10), 1753-1774.
[21] Spiegelhalter, D. J., Abrams, K. R., & Myles, J. P. (2004). Bayesian approaches to clinical trials and health‐care evaluation. Wiley.
[22] Spiegelhalter, D. J., & Freedman, L. S. (1986). A predictive approach to selecting the size of a clinical trial based on subjective clinical opinion. Statistics in Medicine, 5, 1-13.
[23] Storsaeter, J., Hallander, H. O., Gustafsson, L., & Olin, P. (1998). Levels of anti‐pertussis antibodies related to protection after household exposure to Bordetella pertussis. Vaccine, 16(20), 1907-1916.
[24] World Health Organization (2013). Correlates of vaccine‐induced protection: Methods and implications (No. WHO/IVB/13.01). World Health Organization.
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