What is randomization and why is it necessary?
Randomization is like flipping a coin. The treatment will be assigned by chance. This procedure is commonly used in clinical trials when new treatment approaches are being tested, and when there is uncertainty about the best treatment approach. Patients with a Recurrence Score result of 11 to 25 will be randomly assigned to receive, or not to receive, chemotherapy because the benefit of chemotherapy is uncertain in this group, even though chemotherapy would normally be recommended for this group based upon standard characteristics, such as tumor pathology, traditionally used in clinical practice.