What's a Protocol?

A treatment protocol, or clinical trial, is a research study conducted with patients. The purpose of a study is to determine if a new treatment or a variation in treatment will result in a better outcome for patients with a particular disease.

Protocols are based on the best known treatment available for that disease, with additions or changes made which may produce a higher rate of cure or a lower rate of toxic side effects. These additions or changes will have been studied in the laboratory and in small numbers of patients with the disease before being applied in a larger clinical trial. Patients on a protocol will be treated according to the protocol's treatment plan, and will be monitored carefully for the development of known or unknown side effects of treatment. If your child is treated on a protocol, you will receive the schedule of treatments and monitoring tests that will be followed. This schedule is called a "road map".

Sometimes a protocol compares two or more similar treatment plans, or study "arms", in groups of patients with the same disease. Patients are randomised to one of the study arms, which means that they are assigned by random choice (usually by a computer) to receive a particular treatment. This is done to prevent any bias about which might be the best treatment arm for the patient. All of the treatment arms in this type of study include the best known treatment available and are studying additions or variations in treatment. No patient is ever selected to receive "sham" treatment (i.e. false or no treatment, such as a placebo drug). You will know exactly what your child is receiving for treatment.