What is randomization and why is it important?
Randomization is a process that assigns clinical trial participants by chance, rather than by choice, to one of two (or more) groups. In large phase III trials, the “investigational group” receives the new cancer treatment under study. The “control group” or “reference group” receives the standard, currently accepted therapy. In smaller phase II trials, both groups are generally “investigational,” but may involve a different dose and/or schedule of the new cancer treatment. Participants are randomly assigned so that bias does not weaken the study results. The goal is to have comparable groups with similar characteristics, such as age, gender, cancer type and cancer stage. In a well-balanced randomized trial, if one group has a better outcome than the other, the investigators may conclude with some confidence that one cancer treatment is better than the other.
