Being informed about all of your options is an important step toward being an empowered patient. It is natural to have questions, and we've put together answers to some of the most common questions that you may have. If you don't see the answer to your question, email us.
Clinical trials are the final step in the research process and a great deal of effort goes into ensuring they are conducted safely and ethically. After researchers spend many years developing potential treatments in the lab, they write a plan for conducting research with humans. This plan is called a protocol. A clinical trial protocol describes the types of patients who may enter the trial, the schedules of tests and procedures, drugs, dosages, duration, and outcomes that will be measured. The protocol must be approved by an Institutional Review Board (IRB) before a clinical trial may begin. The IRB will review and approve protocols to make sure that clinical trials are ethical and that volunteers’ rights are protected. To protect the rights and welfare of clinical trial participants, US federal agencies, including the FDA and the National Institutes of Health (NIH), oversee much of the medical research in the United States. Federal agencies inspect individuals and institutions conducting clinical trials. IRBs oversee the centers where clinical trials take place. Federal agencies oversee IRBs.
All investigational medications and treatment must be safe and efficacious. In cancer trials, investigational treatments usually added onto or tested against the current standard of care for that cancer. To decrease the potential for research bias, clinical trial participants are randomized to receive either the investigational treatment or the standard of care. All participants in cancer clinical trials receive either the investigational treatment or standard of care. Clinical trials for melanoma, and other cancers, do not use placebos as comparators except in extremely rare circumstances when there is no standard of care that is viewed as safe/effective. It is important to understand which standard of care is being used in the trial before you agree to participate. For example, some melanoma trials may still use chemotherapy as the standard of care. It is important to make sure you understand all the treatments—investigational and approved—involved in each clinical trial you are considering.
Informed consent is the process of learning about a clinical trial before agreeing to participate. To help you decide if you want to participate, the doctors and nurses involved in the trial explain the details of the study. They will provide you with an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. You then decide if you want to sign the document and join the trial. Informed consent is not a contract—participation is always voluntary and you may end your participation at any time. The informed consent process ensures you have the facts you need before making a final decision.
Many people use the terms clinical trial and clinical study interchangeably. But, sometimes the research being done is not trialing or testing a new treatment but may be collecting tissue samples from patients for study, or analyzing the characteristics of patients long after they finish treatment. A research project like this that involves human volunteers is more accurately termed a clinical study, but many still refer to it as a clinical trial.
You can contact doctors conducting clinical trials directly. You do not need a referral from another doctor. Your oncologist may be conducting clinical trials or you may want to join a trial that is only being conducted by another oncologist and/or at another cancer center. Whatever you choose, you should feel empowered to make these types of decisions for yourself. Not all oncologists know about all the options available and many do not discuss clinical trials with their patients. Therefore, being proactive about finding oncologists who are conducting clinical trials is in your best interest. You can find clinical trials for melanoma through www.clinicaltrials.gov and through the National Cancer Institute. All clinical trial descriptions include contact information to learn more about the trial. You can contact the person listed yourself or you can share the information with your oncologist.
Get matched to a melanoma clinical trial that's right for you. Print your results or contact study coordinators directly to get started!
Reality: Participating in a trial is voluntary, and you may leave at any time, for any reason. If you are not responding to an investigational treatment or if side effects are severe you can discuss other treatment options with your doctor.
Reality: In some clinical trials, a patient may receive a placebo and a standard of care treatment, but no patient receives only a placebo unless no known effective treatment exists. In metastatic melanoma trials, the control arm will receive a current FDA-approved standard of care (what you'd likely get if you weren't participating in a trial). Most such trials compare the new experimental treatment with the treatment used in the current standard of care. Even if you receive the standard of care, you are part of a greater effort to find the next generation of treatments and ultimately a cure for melanoma.
Reality: Joining a clinical trial is a viable treatment option for people with melanoma, and all cancers, and participation often represents patients' best access to cutting-edge research. When making treatment decisions, patients should consider all their treatment options, including clinical trials.
Reality: The trial sponsor usually pays for the experimental therapy. They may also pay for any additional tests or visits to your doctor. Patients, or their insurance (if insured), are responsible for the usual costs of care-such as doctor visits, tests, or imaging that you would need regardless of being in a clinical trial.
Reality: Not all doctors are aware of all options available all the time, so being proactive is in your best interest. You can contact clinical trials directly, and you do not need a referral from a doctor. The Clinical Trial Navigator from the Melanoma Research Alliance can connect you to a network of trials, with no commitment or obligation.
Reality: The Food and Drug Administration (FDA) safeguards and protects volunteers throughout the clinical trial process. Before any research can begin, a sponsor must submit extensive information on clinical plans, studies on animals or prior human research, how the drug is manufactured and how the trials will be carried out.
The FDA team that reviews the plan includes a microbiologist, a medical officer, a chemist, a statistician, and a pharmacologist. In its role overseeing the welfare of volunteers, the FDA inspects study sites and anyone involved in the research. Clinical trials must meet federal standards.
Reality: Participating in a clinical trial may mean more checkups, blood tests or biopsies, but your care is being more closely monitored and you will have greater information about your treatment. You can learn more about time requirement up-front by asking questions of the study coordinator.
Reality: Often, major cancer centers are the focal points of research because they offer more comprehensive facilities. However, many clinical trials are available at regional or local hospitals or offices too.
Try the Melanoma Research Alliance Clinical Trial Navigator to find a trial near you.
Reality: All treatments and medications currently available, first went through clinical trials. Without clinical trials, and the many patient volunteers who make them possible, our entire medical research process would stop.
