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Patient accrual and interim statistical analysis in long‐term randomized clinical trials: The French chronic lymphocytic leukemia CLL 80 protocol as a case study
Author(s) -
Chastang Claude,
Travade Philippe,
Benichou Jacques,
Dighiero Guillaume,
Binet JacquesLouis
Publication year - 1986
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.4780050511
Subject(s) - interim analysis , interim , chronic lymphocytic leukemia , medicine , randomization , randomized controlled trial , accrual , stage (stratigraphy) , clinical trial , protocol (science) , clinical endpoint , oncology , leukemia , pathology , alternative medicine , paleontology , accounting , archaeology , earnings , biology , business , history
Abstract The CLL 80 clinical trial of treatment for chronic lymphocytic leukemia was designed using a three‐stage prognostic classification. Within each stage patients received one of two treatments allocated by randomization, two adjacent stages having a common treatment. The fixed‐sample design required 850 patients entered over a period of 8.5 years. Active patient recruitment led to 741 patients being randomized in four years. The first interim analysis, carried out at this point, showed a treatment difference in one stage which was statistically significant ( p = 0.001) and justified an early termination of the protocol. This paper discusses practical aspects of patient accrual and interim analysis in this study.