Before the U.S. Food and Drug Administration (FDA) approves a medication or treatment for public use, it first must go through several phases of study which is known as a clinical trial. During each phase, researchers evaluate how well the treatment works and take note of any side effects.
Clinical trials are key to bringing new treatments to patients, as we have seen with melanoma. Through the efforts and commitment of many patients, as well as companies, doctors and researchers, there are 11 new melanoma treatments approved by the FDA since MRA’s founding in 2007.
The pharmaceutical or biotechnology companies developing the drug provide funding for the studies. However, their research teams rely on medical organizations, such as cancer centers and patient groups, to find people who are willing to participate in the clinical trials.
Deciding whether or not to join a clinical trial is a complex decision. If you or someone you love is considering a clinical trial, you might consider the following.
Things to Consider About Participating in a Clinical Trial
- Early access to new, and possibly improved, treatment: One of the goals of a clinical trial is to see if a new treatment, or a combination of existing treatments, works against the disease and what side effects it may have relative to the standard of care that’s currently given. It’s possible that the treatment you receive in a clinical trial will be an improvement over existing treatments. However, there’s no guarantee; just because results look promising in a lab does not mean that a treatment will work well in humans. And sometimes something looks promising in early trials but does not end up being effective once tested in late phase trials. It’s possible that the new treatment will help others, but it won’t help you. (By the way, participants in cancer treatment studies never receive a placebo, or “fake,” treatment. Instead, the new treatment is usually studied in comparison to the current standard therapy.)
- Side effects: One of the goals of a clinical trial is to figure out a treatment’s side effects and their severity. Medications affect everyone differently. However, it is possible that you may experience mild to severe side effects.
- Frequent, expert medical attention: Doctors and care teams must closely monitor health-related changes in clinical trial participants and record the effects of a treatment, its side effects, and to gauge how well it’s working. That could mean extra trips to the doctor’s for checkups, blood tests, and biopsies. But that means you will have more one-on-one care.
- Free or low-cost treatment: The research company may offer the new treatment at no or low cost to you. But even if a research company covers medication costs, you could still be responsible for copays for extra office visits and tests. Check with your insurance provider before you agree to a clinical trial and find out what expenses you have to cover.
- Help save lives: The melanoma treatments available today exist because other people agreed to try them out. What researchers learn from your participation in a clinical trial could benefit the health of other patients. In general, cancer patients seem highly willing to be part of the movement to improve the nature of treatment for others with this terrible disease. But new treatments could be made available even faster if even more patients participated in the clinical trial process.
Since its founding in 2007, the Melanoma Research Alliance has committed nearly $68 million to fund melanoma research, and has supported 21 clinical trials. With our help – and the help of patients – researchers will continue to explore new ways to fight melanoma and other cancers.
Read more about research funded by the Melanoma Research Alliance and what it takes to develop a new cancer treatment.