Randomization

Some scientific studies require a process called randomization. This means that after
parents agree to enroll their child in a clinical trial, a computer will randomly assign
the child to one arm of the study. If there are three arms, the parents will not know
which of the three (one standard, two experimental) their child will receive until the
computer assigns one. The purpose of computer assignment is to ensure that patients
are evenly assigned to each treatment plan without bias from physicians or families.
One group of patients (the control group) always receives the standard treatment to
provide a basis for comparison to the experimental arms.
At the time the clinical trial is designed, there is no conclusive evidence to indicate
which arm is superior. It is therefore not possible to predict if your child will benefit
from participating in the study. Most arms incorporate standard therapy, and only a
small portion of the arm contains the “experimental” therapy. This may consist of new
drugs, old drugs used in a new way, duration of treatment that is shorter or longer
than standard care, the addition or deletion of certain treatments (such as radiation
therapy), or the use of new supportive care interventions, such as preventative anti-
biotics or new drugs to control nausea.
We decided not to participate in a study for several reasons. One arm
would require extra spinal taps, and our son was just so little that we
couldn’t bear the thought of any more treatments than were required in
the standard arm. Another arm contained a second induction, and since
we were on Medicaid, we just didn’t feel it was right for the taxpayers to
]pay for anything extra. We felt we were only entitled to basic
healthcare.
• • • • •
We had a hard time deciding whether to go with the standard
treatment or to participate in the study. The “B” arm of the study
seemed, on intuition, to be too harsh for her because she was so weak
at the time. We finally did opt for the study, hoping we wouldn’t be
randomized to “B.” We chose the study basically so that the computer
could choose and we wouldn’t ever have to think “we should have gone
with the study.” As it turned out, we were randomized to the standard
arm, so we got what we wanted while still participating in the study.
Researchers closely monitor ongoing studies and modify the study if one arm is
clearly identified as superior during the course of the trial.