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Health Protocols

Brain Tumor - Glioblastoma

Participating in a Clinical Trial

Before any new cancer tests or treatments are made available, they must first pass through a series of clinical trials to ensure that they are effective and safe in patients. For some patients with glioblastoma, participation in one of these clinical trials may be the best or perhaps only option. Ask your medical team about available clinical trials when they are presenting treatment options and work with them to decide if being part of a clinical trial is right for you.

Clinical trials that eventually lead to approved treatments are conducted in five phases (IOM 2012; Kummar 2008; Prielipp 2016):

  • Phase 0 clinical trials are preliminary trials that enroll few (10‒15) people to examine whether an intended drug would have an effect on the human body, as predicted from laboratory and animal studies. These trials determine whether further clinical development should proceed.
  • Phase I clinical trials involve a small number of people (around 20‒80). They mostly focus on testing the safety of a drug, and seek to find the highest dose of the drug that can be given safely and without the risk of adverse effects.
  • If a drug has passed phase I, it moves on to a phase II clinical trial. In phase II clinical trials, which involve larger groups of people (100‒300), researchers gather data on how effective the drug is for treating a specific type of disease, and study its safety in more detail.
  • If phase II results are promising, phase III clinical trials are conducted to compare the new drug to the standard treatment. These trials usually involve large numbers of people (hundreds or thousands) and are critical for demonstrating the value of the new drug to the Food and Drug Administration (FDA) and the medical community.
  • Lastly, phase IV trials are conducted on already-approved treatments to examine their long-term effects on even larger groups of people. Sometimes phase IV trials examine other potential benefits of the drug or discover additional side effects.

Clinical trials have strict rules on who can participate. For instance, a trial might be restricted to patients who have not yet been treated for their disease or have tumors with a specific characteristic.

Participation in a trial has some risks, such as unexpected side effects, and the new treatment may not be effective. However, participants may be among the first to have access to cutting-edge treatments and will receive the highest standard of patient care. Regardless of the trial outcome, every participant helps researchers improve treatment options for future patients.

The following websites may be helpful for finding out more about clinical trials and clinical trial participation: