Choosing to participate in a clinical trial is a very personal decision. To make this choice, it is necessary to have as much information as possible. Below is a list of frequently asked questions with information that may be helpful in making your decision.
What is a clinical trial?
A clinical trial is a health-related research study that tries to answer a question - what is the best care for our patients? There are two kinds of clinical trials: interventional studies and observational studies.
- Interventional Studies: A patient can use a new drug or device to see if it is helpful.
- Observational Studies: A patient is observed and monitored by a physician.
Why should I participate in a clinical trial?
Participating in a clinical trial can let you have a bigger role in your own healthcare and can give you access to new treatments before they are available to the public. Participating in research can also allow you to help others in the future because you can help us figure out which drug or device is best for care.
Who can participate in a clinical trial?
You can participate in a clinical trial if you meet certain guidelines for the study. Guidelines are different for each study and can be based upon age, gender, the type and stage of a disease, previous treatments, and other medical problems. Being very strict in selecting people for research is necessary so that the study is as safe and successful as possible.
What happens during a clinical trial?
The team that runs the clinical trial may include doctors, nurses, social workers and other health care professionals. They check the health of the participant at the start of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is over.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Participating in a clinical trial is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
What is informed consent?
Informed consent is the process of learning the important facts about a clinical trial before deciding whether or not you want to participate. The consent process continues throughout the study to provide information for participants. To help you decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If your native language is not English, translation assistance can be provided. The research team then provides an informed consent document that includes details about the study, such as its purpose, how long it will last, what tests are needed, and who to contact for questions or problems. Risks and potential benefits are explained in the informed consent document. You can then decide whether or not to sign the document. Informed consent is not a contract, and you may withdraw from the trial at any time without any risk to your future care.
What are the benefits and risks of joining a clinical trial?
Clinical trials are the best way for you to:
- Play an active role in your healthcare.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
There are risks to clinical trials.
- There may be unpleasant, serious or even life-threatening side effects to research treatment.
- The research treatment may not be effective for you.
What are side effects and adverse reactions?
Side effects are any undesired actions or effects of the research drug or treatment. These may include headache, nausea, hair loss, skin irritation, or other physical problems. Research treatments must be evaluated for both immediate and long-term side effects.
How is my safety protected if I join a clinical trial?
The ethical and legal codes that are used in medical practice are also used in clinical trials. Also, clinical research is regulated by the government. Research must have built in safeguards to protect you if you choose to participate. The trial follows a carefully controlled protocol. A protocol is a study plan which says exactly what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB). The IRB makes sure the risks are as low as possible and are worth any potential benefits. An IRB is a group of doctors, research experts, community members, and others. The committee ensures that a clinical trial is ethical and the rights of study participants are protected. All places that do research involving people must, by federal regulation, have an IRB that initially approves and reviews the research over time.
What should I consider before participating in a trial?
You should know as much as possible about the clinical trial. You should feel comfortable asking the members of the healthcare team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for you to discuss with the healthcare team. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the treatment being tested may be effective? Has it been tested before?
- What kinds of tests and research treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will I need to be in the hospital?
- Who will pay for the research treatment?
- Will I receive any money for expenses?
- What type of long-term follow-up care is part of this study?
- How will I know that the research treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
How should I prepare for the meeting with the research coordinator or doctor?
- Plan ahead and write down questions to ask.
- Ask a friend or relative to come along for support and to hear the questions and answers
- Bring a tape recorder to record the discussion to replay later.
Do I still see my primary healthcare provider while I'm participating in a trial?
Yes. Most clinical trials do not provide complete primary healthcare. By having your health care provider work with the research team, you can ensure that other medications or treatments that you are taking will not be a problem with the research study.
Can I leave a clinical trial after it has begun?
Yes. You can leave a clinical trial at any time. When leaving the trial, you should let the research team know about it, and the reasons for leaving the study.
Where do the ideas for trials come from?
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the research treatments with the best results are moved into clinical trials. During a trial, more and more information is gained about a research treatment, its risks and how well it may or may not work.
Who sponsors clinical trials?
Clinical trials can be sponsored or funded by physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies. They can also be funded by federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations. Some of these locations are hospitals, universities, doctors' offices, or community clinics
What is a protocol?
A protocol is a study plan for a clinical trial. The plan is carefully designed to protect the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff. This staff monitors the participants' health and determines the safety and effectiveness of their treatment.
What is a control or control group?
A control group is the group used to compare a research treatment. In many clinical trials, one group of patients will be given a research drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, research treatments are often compared with placebos to see how effective the new treatment really is. In some studies, the participants in the control group will receive a placebo instead of an active drug or research treatment.
What are the different types of clinical trials?
- Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
- Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening trials test the best way to detect certain diseases or health conditions.
- Quality of life trials (or supportive care trials) look at ways to improve comfort and the quality of life for patients with a chronic illness.
What are the phases of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help researchers answer different questions:
- In Phase I trials, researchers test a research drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase II trials, the research study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase III trials, the research study drug or treatment is given to large groups of people (1,000-3,000) show how well it works, monitor side effects, compare it to commonly used treatments, and collect information that will allow the research drug or treatment to be used safely.
- In Phase IV trials, the side effects and benefits of medicines already approved for use are observed. This gives researchers more information about a drug's risks, benefits, and best uses.