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A reversal of fortune: Practical problems in the monitoring and interpretation of an EORTC breast cancer trial
Author(s) -
Sylvester Richard,
Bartelink Harry,
Rubens Robert
Publication year - 1994
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4780131306
Subject(s) - interim , interim analysis , breast cancer , clinical trial , accrual , medicine , hormonal therapy , interpretation (philosophy) , cancer , oncology , medical physics , computer science , history , accounting , archaeology , earnings , business , programming language
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 × 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.