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 antibiotics 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.
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