Summary
Proper design and conduct of a clinical trial requires the consideration of a set of principles. These principles include the collaborative effort, consideration of both a medical and a statistical plan, and development of a data network. The Ludwig Breast Cancer Study Group with international participants has been formed according to these principles. This represents an approach to clinical trials which is designed to maximize the scientific pay-off. The goal is to determine the optimal treatment for every identifiable prognostic subgroup of patients.
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Ahmann, D. L., O’Connell, M. J., Hahn, R. G., Bisel, H. F., Lee, R. A., Edmonson, J. H.: An evaluation of early or delayed adjuvant chemotherapy in premenopausal patients with advanced breast cancer undergoing oophorectomy. N. Engl. J. Med. 297, 356–360 (1977)
Bonadonna, G., Rossi, A., Valagussa, P., Banfi, A., Veronesi, U.: The CMF program for operable breast cancer with positive axillary nodes. Cancer 39, 2904–2915 (1977)
Brunner, K. W., Sonntag, R. W., Alberto, P., Senn, H. J., Martz, G., Obrecht, P., Maurice, P.: Combined chemo- and hormonal therapy in advanced breast cancer. Cancer 39, 2923–2933 (1977)
Cole, M. P.: Suppression of ovarian function in primary breast cancer. In: Prognostic factors in breast cancer. Forrest, A. P. M., Kunkler, E. S. (eds.), pp. 146–156. Edinburgh, London: Livingston 1968
Fisher, B., Slack, N., Katrych, D. L., Wolmar, K. N.: Ten year follow-up of breast cancer patients in a cooperative clinical trial evaluating surgical adjuvant chemotherapy. Surg. Gynecol. Obstet. 140, 528–534 (1975)
Fisher, B., Glass, A., Redmond, C., Fisher, E. R., Barton, B., Such, E., Carbone, P., Economou, S., Foster, R., Frelick, R., Lerner, H., Levitt, M., Margolese, R., MacFarlane, J., Plotkin, D., Shibata, H., Volk, H. (and other cooperating investigators): L-Phenylalanine Mustard (L-PAM) in the management of primary breast cancer. Cancer 39, 2883–2903 (1977)
Freiman, J. A., Chalmers, T. C., Smith, H., Jr., Kubler, R.: Importance of beta type error and sample size in the randomized control trial. N. Engl. J. Med. 299, 690–694 (1978)
Meakin, J. W., Allt, W. E. C., Beale, F. A., Brown, T. C., Bush, R. S., Clark, P. M., Fitzpatrick, P. J., Hawkins, N. V., Jenkin, R. D. T., Pringle, J. F., Rider, W. D.: Ovarian irradiation and prednisone following surgery for carcinoma of the breast. In: Adjuvant therapy of cancer. Salmon, S. E., Jones, S. E. (eds.), pp. 95–99. Amsterdam: Elsevier/North Holland, Biomed. Press 1977
Nissen-Meyer, R.: The role of prophylactic castration in the therapy of human mammary carcinoma. Eur. J. Cancer 3, 395–403 (1967)
Nissen-Meyer, R., Kjellgren, K., Malmio, K., Mansson, B., Norin, T.: Results with one short course with cyclophosphamide after mastectomy for breast cancer. Cancer 4, 2088–2098 (1978)
Ravdin, R. G., Lewinson, E. F., Slack, N. H.: Results of a clinical trial concerning the worth of prophylactic oophorectomy for breast carcinoma. Surg. Gynecol. Obstet. 141, 1055–1064 (1970)
Stjernswärd, J.: Adjuvant radiotherapy trials in breast cancer. Cancer 39, 2846–2867 (1977)
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© 1980 Springer-Verlag Berlin Heidelberg
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Ludwig Breast Cancer Study Group. (1980). Principles of Clinical Trials. In: Henningsen, B., Linder, F., Steichele, C. (eds) Endocrine Treatment of Breast Cancer. Recent Results in Cancer Research / Fortschritte der Krebsforschung / Progrès dans les recherches sur le cancer, vol 71. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-81406-8_29
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DOI: https://doi.org/10.1007/978-3-642-81406-8_29
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