Understanding Clinical Trials
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If your doctor suggests that you look into a melanoma clinical trial or research study, it does not mean that your case is hopeless. Many melanoma patients take part in clinical trials and are among the first to benefit from treatments that have shown promise in early research. In fact, all of the melanoma treatments currently available have been tested in clinical trials. This section was put together from the National Institutes of Health’s (NIH) clinical trial information to help you better understand research studies, why they’re done and how they work. You can visit the NIH website for even more detailed information about clinical trials, or click here to learn more about the Oncophage research study.
WHAT IS A CLINICAL TRIAL?
A research study is a study designed to determine how safe and effective a new therapy is. People who participate in research studies receive excellent medical care and may be able to try promising treatments before they are available to the general public.
WHAT IS A PROTOCOL?
All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the study; the schedule of tests, procedures, medications and dosages; and the length of the study. While in a research study, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of the treatment.
WHAT ARE CLINICAL TRIAL PHASES?
Clinical trials of experimental treatments are usually done in three phases.
| PHASE 1 |
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| PHASE 2 |
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| PHASE 3 |
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If the drug or treatment successfully makes it through all phases of the research studies, an application is filed to request approval from the US Food and Drug Administration (FDA) so that the drug can be made available to the general public.
The study of Oncophage in melanoma is a Phase 3 research study.
WHAT PROTECTIONS ARE THERE FOR PEOPLE WHO PARTICIPATE IN CLINICAL TRIALS?
The government has strict guidelines and safeguards to protect people who choose to participate in research studies. Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.
An IRB is an independent committee of physicians, statisticians, community advocates and others that ensures that a clinical trial is ethical and the rights of study participants are protected. By federal regulation, all institutions that conduct or support biomedical research involving people must have an IRB that initially approves and periodically reviews the research.
WHAT IS INFORMED CONSENT?
Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. These facts include:
- Why the research is being done
- What the researchers want to accomplish
- What will be done during the study and for how long
- What risks are involved in the trial
- What benefits can be expected from the study
- What other treatments are available
- The fact that you have the right to leave the trial at any time
If you are considering joining a research study, the research staff will give you informed consent documents that include the details about the study. Because joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study and the consent forms before you make a decision.
It is also a good idea to take the consent documents home and discuss them with family members or friends. Talking about your options can help you to feel comfortable with your decision. If you decide to join the research study, be sure to ask for a copy of the informed consent documents so that you can review them at any time.
Remember that informed consent is more than signing a form. It is a process that continues throughout the trial. You should feel free to ask the research team questions before, during and after the study. Informed consent continues as long as you are in the trial.
WHO CAN PARTICIPATE IN A CLINICAL TRIAL?
All research studies have guidelines about who can get into the program. Guidelines are based on such factors as age, type of disease, medical history and current medical condition. Before you join a clinical trial, you must qualify for the study. Some research studies seek volunteers with illnesses or conditions to be studied in the research study, whereas others need healthy volunteers. Healthy volunteers participate in Phase 1 trials, some vaccine studies and trials on research on preventive care for children or adults.
The factors that allow you to participate in a clinical trial are called inclusion criteria and the factors that keep you from participating are called exclusion criteria. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
WHO SPONSORS RESEARCH STUDIES?
Research studies can be sponsored by:
- Pharmaceutical and biotechnology companies
- Government agencies like the National Institutes of Health
- Individual researchers
- Health care institutions like health maintenance organizations
Although studies may be paid for by different groups, the FDA has strict guidelines and safeguards to protect the safety and rights of the volunteers, including regulation of patient compensation and coordinating with hospitals to make sure that every research study going on in the United States is properly monitored.
WHAT HAPPENS DURING A CLINICAL TRIAL?
The clinical trial process depends on the kind of trial in which you participate. The team will include doctors and nurses as well as social workers and other health care professionals. They will check your health at the beginning of the trial, give you specific instructions for your participation, monitor you carefully during the study, and stay in touch with you afterwards. Your participation will be most successful if you follow the protocol carefully and stay in contact with the research staff.
WHAT IS A CONTROL OR CONTROL GROUP?
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, and the control group is given either a standard treatment for the illness or a placebo.
WHAT ARE SIDE EFFECTS AND ADVERSE REACTIONS?
Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
WHAT ARE THE BENEFITS AND RISKS ASSOCIATED WITH CLINICAL TRIALS?
There are both benefits and risks associated with clinical trials. By participating in a clinical trial, you can:
- Take an active role in your own health care
- Gain access to new treatments that are not available to the public
- Obtain expert medical care at leading health care facilities during the trial
- Help others by contributing to medical research
Clinical trials also have risks such as:
- There may be side effects or adverse reactions to medications or treatments
- The treatment may not be effective for you
- The protocol may require a lot of your time for trips to the study site, treatments, hospital stays or complex dosage requirements
CAN I LEAVE A CLINICAL TRIAL AFTER IT HAS BEGUN?
Yes, you can leave a research study at any time. If you plan to stop participating, let the research team know why you are leaving the study.
| Sponsored by Antigenics, a biotechnology company that is working to develop cancer vaccines and other treatments for serious illnesses. The information provided on this site is intended to support, not replace, the relationship that exists between a patient/site visitor and his/her physician. |  |