In order for new treatments to be developed, clinical trials are performed to test how well a new drug or device works. Have you ever thought about taking part in a clinical trial? If so, here are some important things to know:
What are clinical trials?
Clinical trials are designed to answer two main questions: Does this treatment work in people? And is it safe? The trials are done in three or more phases:
• In phase zero, a few patients are given small doses of the new treatment to see how they react to it.
• Phase one focuses on safety. It works to determine how people respond to different doses. Doctors watch for side effects. Most patients involved in this phase have already been through other treatments and had no results. This phase has the most risk to patients, but can also be very beneficial.
• In phase two, the treatment is tested to see how effective it is and whether it improves patient outcomes.
• Phase three compares the treatment to currently available options to see if the new method is better. Participants are randomized, some receive the new treatment and others the standard method. This is a double-blind study, which means that neither the patient or doctor knows which treatment the patient receives. This allows for completely unbiased reporting of the effects of the new treatment.
Once the third phase is complete, the treatment is submitted for U.S. Food and Drug Administration approval. If granted, the treatment can be used in standard care. Often, phase four studies continue for several years to see if the treatment is safe over time.
The main sponsors of clinical trials are the federal government and major cancer cooperative groups, like the National Cancer Institute and the National Institutes of Health. Pharmaceutical and biotechnology companies also sponsor trials for drugs and treatments they develop.
Talk with your doctor
If you are interested, ask your doctor if they know of a clinical trial that you may get involved with. Many doctors are themselves working on one or know a fellow health care professional who is, and can recommend that trial.
The news highlights the negatives
Often, when people hear the term "clinical trial" they think only of instances of harm or death that have been documented on the news. Unfortunately, the media tends to paint trials in a negative light. According to the American Cancer Society, many trials are successful and have plenty of positive outcomes, but the few cases where something goes wrong are what garners the media's attention. Don't let that fool you.
There is no right answer
Should you partake in a clinical trial? It's entirely up to you. If you want to help doctors working towards a cure for your particular disease, it is something to consider. Not only would you be potentially helping yourself by being involved, you could be assisting many other people who would benefit from the drug or device being tested in the trial. There is always risk involved when trying something new, so it is important to be aware of that as well and keep asking questions until you are satisfied with the answers.