What is a Clinical Trial Protocol?
The protocol is a detailed plan for the clinical trial. It explains exactly what will be done in the trial and includes information about the reason for the study, the number of people who will participate, eligibility criteria, details about the drug or other treatments that will be used, tests that will done, information that will be gathered, and the measures that will be used to evaluate the results.
What is randomization?
Randomization means that participants are assigned to one of two or more groups (sometimes called "arms") in the study—either the experimental group that receives the new treatment, or a control group that receives the existing standard of care.
Randomization is important because it helps ensure that other effects (beyond those being studied) do not bias or influence the results when the two groups are compared. That is, randomization ensures that differences in results between the two groups are due to different treatments and not for other reasons.
Participants have an equal chance of being assigned to the new treatment (experimental) or control (standard care) group. A computer program is used to make the assignments. The doctor or other health care professional does not choose the participants for each group.
Will I get a placebo?
A placebo—sometimes referred to as a "sugar pill"—looks like the drug being tested, but doesn't contain any active drug ingredient. Placebos are almost never used in brain tumor treatment trials. Only in rare cases, in which no standard treatment exists, a study might compare a new treatment with a placebo. This information should be readily available in the trial protocol.
Who can participate in a clinical trial?
The eligibility requirements for each trial are described in the protocol for that trial. Requirements generally relate to the type of brain tumor, age, general health, and other treatments that the person has already had. The requirements are determined (1) to ensure the safety of the study participants, and (2) to generate results that are scientifically meaningful.