User menu

Accès à distance ? S'identifier sur le proxy UCLouvain

A Reversal of Fortune - Practical Problems in the Monitoring and Interpretation of An Eortc Breast-cancer Trial

Primary tabs

Sylvester, Richard J. [UCL] Bartelink, H. Rubens, R.

An example of some of the practical problems associated with the interim monitoring of accumulating time to event data is illustrated through an EORTC clinical trial in locally advanced breast cancer which studied the effects of both hormonal therapy and chemotherapy using a 2 x 2 factorial design. The data monitoring process is described and summaries of the interim statistical analyses and the analysis for publication of the clinical results are provided. The results 2.5 years after closing the trial to patient entry differed quite markedly from those observed during the period of patient accrual, thus showing the potential dangers of drawing conclusions based on only short term follow-up data.

Document type Communication à un colloque (Conference Paper) – Présentation orale avec comité de sélection
Publication date 1994
Language Anglais
Conference "Workshop on Early Stopping Rules in Cancer Clinical Trials", ROBINSON COLL, CAMBRIDGE (England) (Apr 13-15, 1993)
Journal information "Statistics in Medicine" - Vol. 13, no. 13-14, p. 1329-1335 (1994)
Peer reviewed yes
issn 0277-6715
e-issn 1097-0258
Publisher John Wiley & Sons Ltd (W Sussex)
Affiliation UCL - Autre
Links
  1. Rubens R.D., Armitage P., Winter P.J., Tong D., Hayward J.L., Prognosis in inoperable Stage III carcinoma of the breast, 10.1016/0014-2964(77)90134-7
  2. Rubens, European Journal of Cancer and Clinical Oncology, 25, 667 (1989)
  3. Schaake C., Engelsman E., Hamersma E., Pilot Study on Adjuvant Chemotherapy and Hormonal Therapy for Irradiated Inoperable Breast Cancer, Adjuvant Therapies and Markers of Post-Surgical Minimal Residual Disease II (1979) ISBN:9783642813344 p.113-117, 10.1007/978-3-642-81332-0_16
  4. Schaake-Koning Caro, Van Der Linden Els Hamersma, Hart Guus, Engelsman Evert, Adjuvant chemo- and hormonal therapy in locally advanced breast cancer: a randomized clinical study, 10.1016/0360-3016(85)90028-8
  5. George, Journal of Chronic Diseases, 27, 15 (1974)
Bibliographic reference Sylvester, Richard J. ; Bartelink, H. ; Rubens, R.. A Reversal of Fortune - Practical Problems in the Monitoring and Interpretation of An Eortc Breast-cancer Trial.Workshop on Early Stopping Rules in Cancer Clinical Trials (ROBINSON COLL, CAMBRIDGE (England), Apr 13-15, 1993). In: Statistics in Medicine, Vol. 13, no. 13-14, p. 1329-1335 (1994)
Permanent URL http://hdl.handle.net/2078.1/63263