Clinical trials play an important role in getting new drugs and medical devices to market. The US Food and Drug Administration (FDA) requires any new drug or device to be approved before being sold. To gain FDA approval, the manufacturer or distributor of a drug or device must submit full reports of the studies conducted to show that the drug or device is safe and effective for its intended use.
Clinical trials are the primary way for manufacturers to show that their products are safe and effective. They also provide opportunities to learn more about various medical conditions. The results of clinical trials are measured against the best standard therapy available for the particular condition.
Clinical trials are done throughout the world at university hospitals, cancer centers, medical centers and hospitals, and doctors’ offices and clinics. Because brain tumors are relatively rare, many single institutions cannot enroll enough patients to get meaningful data in a reasonable timeframe. As a result, there are a number of a clinical cooperative groups offering brain tumor trials.
Patients interested in participating in a clinical trial can ask a member of the treatment team about it or visit TrialConnect, the American Brain Tumor Association’s clinical trial matching service.
Clinical trial participants are human patients who have volunteered to try a new treatment or medical device. There are several different types of clinical trials, including:
- Supportive care trials
- Prevention trials
- Early detection, or screening trials
- Diagnostic trials
- Treatment trials
Any patient who is interested in a specific clinical trial should ask the trial administrator these and other questions before participating:
- Why is the new treatment thought to be effective? Has it been tested before?
- When did the trial begin?
- How many people have been treated so far?
- How many have my type of tumor?
- How well are the study patients doing?
- What are the known possible side effects of the treatment being tested? Are they temporary or permanent? Can they be controlled or lessened some way (medications, diet, etc.)? How will they affect my daily activities?
- Where will the treatment take place? Can it be given close to my home?
- How many treatments will there be? How long will each one take?
- Will the study doctors work with my doctor while I participate in the study?
- Will I need to be hospitalized for study purposes?
It is important to note that the information provided here does not take the place of professional advice. If you have any questions about how brain tumors are treated, please contact your doctor.