Clinical Trial FAQ
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.
Frequently Asked Questions:
- How are clinical trials conducted?
- What does it mean to be randomized?
- What is informed consent?
- What is the difference between a clinical trial and a clinical study?
- How do I join a clinical trial?
How are clinical trials conducted?
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.
MRA has also made it easy to search clinical trials that you may be eligible for using our Clinical Trial Navigator below:
Read more about whether a clinical trial is right for you on our blog or join the conversation on the Melanoma > Exchange, our online community focused on melanoma research, clinical trials, and treatment.