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Gatekeeping Papers

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This article lists key publications on gatekeeping procedures used in clinical trials with multiple families of objectives (or multiple families of null hypotheses of no effect). The families are often termed gatekeepers and are analyzed in a sequential manner beginning with the family of most important objectives. The families can represent families of endpoints (primary, secondary and tertiary endpoints), tests (non-inferiority, superiority), dose levels (higher doses, lower doses) or various combinations of these. For more information on gatekeeping procedures and their classification, see Gatekeeping Procedures.

For information on publications dealing with procedures used in multiplicity problems with a single family of objectives, see Commonly Used Multiple Testing Procedures.

Serial gatekeeping procedures

Maurer, W., Hothorn, L., Lehmacher, W. (1995). Multiple comparisons in drug clinical trials and preclinical assays: a-priori ordered hypotheses. In Biometrie in der chemisch-pharmazeutischen Industrie. Vollmar J (Editor). Fischer Verlag: Stuttgart. 3-18.

Bauer, P., Roehmel, J., Maurer, W., Hothorn, L. (1998). Testing strategies in multi-dose experiments including active control. Statistics in Medicine. 17, 2133-2146.

Westfall, P. H., Krishen, A. (2001). Optimally weighted, fixed sequence, and gatekeeping multiple testing procedures. Journal of Statistical Planning and Inference. 99, 25-40.

Parallel gatekeeping procedures

Dmitrienko, A., Offen, W., Westfall, P.H. (2003). Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Statistics in Medicine. 22, 2387-2400. See Dmitrienko Offen Westfall 2003.

Dmitrienko, A., Tamhane, A., Wiens, B. (2008). General multistage gatekeeping procedures. Biometrical Journal. 50, 667-677. See Dmitrienko Tamhane Wiens 2008.

Dmitrienko, A., Soulakova, J.N., Millen, B.A. (2011). Three methods for constructing parallel gatekeeping procedures in clinical trials. Journal of Biopharmaceutical Statistics. 21, 768-786. See Dmitrienko Soulakova Millen 2011.

Dmitrienko, A., Kordzakhia, G., Tamhane, A.C. (2011). Multistage and mixture parallel gatekeeping procedures in clinical trials. Journal of Biopharmaceutical Statistics. 21, 726-747. See Dmitrienko Kordzakhia Tamhane 2011.

Kordzakhia, G., Dmitrienko, A. (2013). Superchain procedures in clinical trials with multiple objectives. Statistics in Medicine. 32, 486-508. See Kordzakhia Dmitrienko 2013.

Gatekeeping procedures with general logical relationships

Dmitrienko, A., Offen, W., Wang, O., Xiao, D. (2006). Gatekeeping procedures in dose-response clinical trials based on the Dunnett test. Pharmaceutical Statistics. 5, 19-28. See Dmitrienko Offen Wang Xiao 2006.

Dmitrienko, A., Wiens, B.L., Tamhane, A.C., Wang, X. (2007). Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives. Statistics in Medicine. 26, 2465-2478. See Dmitrienko Wiens Tamhane Wang 2007.

Dmitrienko, A., Tamhane, A., Liu, L., Wiens, B. (2008). A note on tree gatekeeping procedures in clinical trials. Statistics in Medicine. 27, 3446-3451. See Dmitrienko Tamhane Liu Wiens 2008.

Dmitrienko, A., Tamhane, A., Liu, L. (2008). Mixtures of multiple testing procedures with gatekeeping applications. Northwestern University. Department of Industrial Engineering and Management Sciences. Working Paper 08-04. See Dmitrienko Tamhane Liu 2008.

Bretz, F., Maurer, W., Brannath, W., Posch, M. (2009). A graphical approach to sequentially rejective multiple test procedures. Statistics in Medicine. 28, 586-604. See Bretz Maurer Brannath Posch 2009.

Burman, C.-F., Sonesson, C., Guilbaud, O. (2009). A recycling framework for the construction of Bonferroni-based multiple tests. Statistics in Medicine. 28, 739–761. See Burman Sonesson Guilbaud 2009.

Dmitrienko, A., Tamhane, A.C. (2011). Mixtures of multiple testing procedures for gatekeeping applications in clinical trials. Statistics in Medicine. 30, 1473-1488. See Dmitrienko Tamhane 2011.

Brechenmacher, T., Xu, J., Dmitrienko, A., Tamhane, A.C. (2011). A mixture gatekeeping procedure based on the Hommel test for clinical trial applications. Journal of Biopharmaceutical Statistics. 21, 748-767. See Brechenmacher Xu Dmitrienko Tamhane 2011.

Millen, B.A., Dmitrienko, A. (2011). Chain procedures: A class of flexible closed testing procedures with clinical trial applications. Statistics in Biopharmaceutical Research. 3, 14-30. See Millen Dmitrienko 2011.

Dmitrienko, A., Millen, B.A., Brechenmacher, T., Paux, G. (2011). Development of gatekeeping strategies in confirmatory clinical trials. Biometrical Journal. 53, 875-893. See Dmitrienko Millen Brechenmacher Paux 2011.

Dmitrienko, A., Tamhane, A.C. (2013). General theory of mixture procedures for gatekeeping. Biometrical Journal. In press. See Dmitrienko Tamhane 2013.

Review papers and chapters

For more information on gatekeeping procedures in clinical trials, see

  • Dmitrienko, A., Tamhane, A.C. (2007). Gatekeeping procedures with clinical trial applications. Pharmaceutical Statistics. 6, 171-180. See Dmitrienko Tamhane 2007.
  • Dmitrienko, A., Tamhane, A.C. (2009). Gatekeeping procedures in clinical trials. Multiple Testing Problems in Pharmaceutical Statistics. Dmitrienko, A., Tamhane, A.C., Bretz, F. (editors). Chapman and Hall/CRC Press, New York. This is Chapter 5 in Multiple Testing Problems in Pharmaceutical Statistics published in 2009 in the Chapman and Hall/CRC Biostatistics Series. See Dmitrienko Tamhane 2009.