What Are Clinical Trials?

Clinical trials, also called research studies, test how well new medical treatments and therapies work in melanoma and other diseases. New treatments and therapies are often measured against what is currently being used, which is called the standard of care.  The goal of clinical trials is to find more effective therapies and treatments for melanoma than the standard of care.

Clinical trials are essential to learning more about melanoma and how to prevent or cure it. Clinical trials test many types of treatments such as new drugs, new approaches to surgery or radiation therapy, new combinations of drugs, or new methods of treatment such as gene therapy. Today’s melanoma treatments would not be available without the clinical trial process. 

Why Should I Consider a Clinical Trial?

Your goal is to find the best treatment available whenever you make a treatment decision. There may be a good standard of care for you—care that experts believe is appropriate for your specific melanoma diagnosis and treatment history.

Sometimes, though, the current standard of care is not as effective as you and your doctor would like. Sometimes the standard of care works for a while but then stops working. Sometimes there is no standard of care for your situation. At these times, participation in a clinical trial may be the best option for you.

Of course, there is no guarantee that a new treatment being tested will produce good results. New treatments may also have unknown risks. But if a new treatment proves effective or more effective than the standard treatment, patients in the clinical trial will be the first to benefit.

In the past, clinical trials were sometimes seen as a last resort for people who had no other treatment choices. Today, patients with common cancers often choose to receive their first treatment in a clinical trial because of the robust research currently taking place.

When Should I Consider a Clinical Trial?

The best time to consider a clinical trial is each time you are faced with a treatment decision.

Register with our clinical trial service so you know all your options and can make informed decisions about your care. Clinical Trials Navigators are available to speak with patients and caregivers Monday through Friday, 8:30 am – 6:00 pm Eastern Time at 866-603-4507 (toll-free). All information is kept in the strictest confidentiality. You can also create a profile online at EmergingMed Matching Service. Click the image below to find a melanoma clinical trial.

What Happens in a Clinical Trial?

In a clinical trial, patients receive treatments that are new and innovative, though not completely proven to work or be risk-free. Some clinical trials will randomize patients to study treatment or standard of care treatment, but the protocol is specific to each clinical trial and should be discussed with your doctor. Doctors carry out research on how the treatment affects the patients and whether the desired results occur. While clinical trials have risks for the people who participate, each study also takes steps to protect patients.

Where Do I Receive Treatment in a Clinical Trial?

When you take part in a clinical trial, you receive your treatment in a cancer center, hospital, clinic, and/or doctor’s office that has qualified to become part of the study. These doctors and institutions must submit a rigorous protocol for approval before they may participate in a clinical trial. Doctors, nurses, social workers, and other health professionals may be part of your treatment team. They will follow your progress closely. You may have more tests and doctor visits than you would if you were not taking part in a study to gain more information on the medication and its effect on you. You will follow a treatment plan your doctor prescribes, and you may also have other responsibilities such as keeping a log or filling out forms about your health. Many studies continue to check on patients even after their treatment is over, and it is common to have mandatory follow-up visits well after treatment has stopped to reassess your health. With a new therapy or treatment, it may be some time before a complete understanding of the effects are realized.

How Are Patients Protected?

Informed consent, as a legal, regulatory, and ethical concept, is an integral part of research. In clinical trials, informed consent is the process of providing all relevant information about the trial’s purpose, risks, benefits, alternatives, and procedures to a potential participant, who then, consistent with his or her own interests and circumstances, makes an informed decision about whether or not to participate. The informed consent process provides people with ongoing explanations that will help them make educated decisions about whether to continue participation in a clinical trial. The process does not end with the signing of informed consent documents. If new benefits, risks, or side effects are discovered during the trial, researchers must inform participants. Participants are encouraged to ask questions at any time. Before agreeing to take part in a clinical trial, participants have the right to learn everything that is involved in the trial – including all details about treatment, tests, and possible risks and benefits. The information has to be in a format and language that can be easily understood.

Why Are Clinical Trials Important?

Cancer affects us all, whether we have it, care about someone who does, or worry about getting it in the future. Clinical trials contribute to our knowledge base and our progress fighting cancer. If a new treatment proves effective in a study, it may soon become a new standard treatment that will help many patients. It’s important to remember that the current standard treatments for melanoma are available because of previous clinical trials. Clinical trials may also answer important scientific questions and suggest future research directions. Because of progress made through clinical trials—especially clinical trials in melanoma—many people are now living longer.