How Do Trials Work?

All clinical trials have specific guidelines on who can or cannot participate. Before you can take part, your doctor will review all of the study requirements with you.

If you meet the requirements, you will be asked to have screening tests. These tests will help determine whether you may take part in this study. Test may include a physical and neurological exam, blood work, diagnostic tests (such as x-rays or MRIs) and study related surveys.

Based on the review of the above information, your physician and the study team will determine if you are eligible to take part in the study. Once it is established that you are an appropriate candidate for a trial, you will then complete the informed consent process prior to officially joining the trial. During this process you will get the main facts about a trial, including risks, benefits and other details.

PHASE I

The first phase is testing a particular medical treatment on people. The goal is to gather information on the dosage, timing and safety of the new medication. The balance is finding the maximum tolerated dose while still maintaining the quality of life and keeping side effects to a minimum.

PHASE II

The second phase is designed to study the safety and how well the new medication works to control side effects, control the growth of tumor or extend the person’s life.

PHASE III

The third phase is designed to evaluate the safety, how well the new medication works and the dosage compared to a standard treatment. Is the new treatment better than current standard treatment in terms of side effects, control of tumor growth or survival? Patients will randomly be assigned to one of two groups. Randomization is important because, if the decision about who receives the new treatment in a clinical trial is not decided by random, the patients and the scientists can influence the results.

PHASE IV

The fourth phase is designed to see how well the new medication works long-term compared to current standard treatment after a drug has been FDA-approved.

If you have just found out that you have a brain tumor or your tumor has recurred, research all the available treatment options – including clinical trials – before making any treatment decisions.