Communication of Randomization in Childhood Leukemia Trials

Abstract

Clinical trials provide the foundation of evidence-based medicine, and randomization is the paramount principle of trial design.^1,2 Despite theoretical concerns about the ethics of randomized trials,^3-7 empirical knowledge is lacking. Thousands of children with cancer have been enrolled in randomized clinical trials (RCTs) during the past 40 years.⁸ The cure of childhood leukemia, one of the great success stories of modern medicine, has been a direct result of these trials.⁹ For children with newly diagnosed leukemia and their families, randomization is the key feature that distinguishes research participation from treatment outside an RCT. Placebos are not used in childhood leukemia RCTs.