Règles d'arrêt précoce dans les essais cliniques basées sur une surveillance séquentielle des événements indésirables graves
Revue de Statistique Appliquée, Volume 53 (2005) no. 4, p. 49-59
     author = {Kramar, A. and Bascoul-Mollevi, C. and Gourgou-Bourgade, S.},
     title = {R\`egles d'arr\^et pr\'ecoce dans les essais cliniques bas\'ees sur une surveillance s\'equentielle des \'ev\'enements ind\'esirables graves},
     journal = {Revue de Statistique Appliqu\'ee},
     publisher = {Soci\'et\'e fran\c caise de statistique},
     volume = {53},
     number = {4},
     year = {2005},
     pages = {49-59},
     language = {fr},
     url = {http://www.numdam.org/item/RSA_2005__53_4_49_0}
Kramar, A.; Bascoul-Mollevi, C.; Gourgou-Bourgade, S. Règles d'arrêt précoce dans les essais cliniques basées sur une surveillance séquentielle des événements indésirables graves. Revue de Statistique Appliquée, Volume 53 (2005) no. 4, pp. 49-59. http://www.numdam.org/item/RSA_2005__53_4_49_0/

[1] Armitage P., Mcpherson C.K., Rowe B.C. ( 1969), Repeated signifiance test on accumulating data, Journal of the Royal Statistical Society, Series A,132 :232-244. | MR 250405

[2] Bryant R., Day R. ( 1995), Incorporating toxicity considerations into the design of two-stage phase II trials, Biometrics, 51 :656-664. | Zbl 0871.62090

[3] UDRAVIGILANCE-CLINICAL TRIALS MODULE (JUILLET 2002), Detailed guidance on the European data base of suspected unexpected serious adverse reactions, draft 2.8.

[4] Goldman A.I., Hannan P.J. ( 2001), Optimal continuous sequential boundaries for monitoring toxicity in clinical trials : a restricted search algorithm, Statistics in Medicine, 20 :1575-1589.

[5] Hwang I.K., Shih W.J., Decani J.S. ( 1990), Group sequential designs using a family of type I error probability spending functions, Statistics in Medicine, 9:1439-1445.

[6] Kramar A., Potvin D., Hill C. ( 1996), Plans expérimentaux pour l'inclusion de patients dans les essais de phase II, Revue d'Epidémiologie et Santé Publique, 44 :364-371.

[7] Lee Y.J., Wesley R.A. ( 1981), Statistical contributions to phase II trials in cancer : interpretation, analysis and design, Seminars in Oncology, 8 :403-416.

[8] O'Brien P.C., Fleming T.R. ( 1979), A multiple testing procedure for clinical trials, Biometrics, 35 :549-556.

[9] O'Oquigley J., Shen L.Z. ( 1996), Continual reassessment method : a likelihood approach, Biométrics, 52 :673-684. | Zbl 0925.62454

[10] Pocock S.J. ( 1977), Group sequential methods in the design and analysis of clinical trials, Biometrika, 64 :191-199.

[11] Rosti G., Pico J.-L., Wandt H., Koza V., Salvioni R., Theodore C., Lelli G., Seigert W., Horwich A., Marangolo M., Schmoll H.J., Linkesch W., Pizzocaro G., Bouzy J., Kramar A., Droz J.-P. ( 2002), High dose chemotherapy in the salvage treatment of patients failing first-line platinum chemotherapy for advanced germ cell tumour; first results of a prospective randomised trial of the European Group for Blood and Marrow Transplantation (EBMT) : IT94 Proeeeding of ASCO, 132 :A716.

[12] Scharfstein D.O., Tsiatis A.A., Robins J.-M. ( 1997), Semiparametric efficiency and its implication on the design and analysis of group sequential studies, Journal of the American Statistical Association, 92 :1342-1350. | Zbl 0913.62075