Introduction to Clinical Trials
Choosing to participate in a clinical trial is an important personal decision. The following frequently asked questions may help you make your decision. In addition, it is often helpful to talk to a physician, family members or friends about deciding to join a trial. It is important to contact the trial research staff and ask questions about specific the trial.
WHAT IS A CLINICAL TRIAL?
A clinical trial is a research study with human volunteers designed to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Because of the information gathered through a trial, new treatments are accepted in the medical community.
WHAT IS "INFORMED CONSENT"?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. Informed consent continues throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then, the research team provides an informed consent document that includes these details, including purpose, duration, required procedures and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
WHAT IS A PROTOCOL?
A protocol explains how the trial must be conducted. A protocol describes:
- The problem to be studied.
- What will be learned from the trial
- Who may participate in the trial
- What will happen during the study: the schedule of tests, any medical procedures, medications and dosages.
- How safety will be maintained.
- How success or failure will be measured.
- How long the trial will last.
The protocol is carefully designed to safeguard the health of the participants while answering the specific research questions. While in the trial, participants following the protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
WHAT ARE THE BENEFITS AND RISKS OF PARTICIPATING IN A CLINICAL TRIAL?
Well-designed and well-executed clinical trials are the best approach for eligible participants to:
- Play an active role in their own health care.
- 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.
The risks to clinical trials include:
- There may be unpleasant or serious side effects to experimental treatment.
- The experimental treatment may not be effective for the participant.
- Getting medical care according to the trial guidelines may require more time and attention than would getting medical care outside of a trial setting
WHAT ARE SIDE EFFECTS AND ADVERSE REACTIONS?
Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse reactions 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.
HOW IS THE SAFETY OF THE PARTICIPANT PROTECTED?
The ethical and legal codes that govern medical practice apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol, the plan which details what researchers will do in the trial. 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 remain secret and are not mentioned in these reports.
WHAT SHOULD PEOPLE CONSIDER BEFORE PARTICIPATING IN A TRIAL?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the costs incurred by the participants during the trial. Here are some questions a participant may want to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the trial?
- Who is going to be in the trial?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects and benefits in the trial compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses such as travel to the trial site?
- What type of long-term follow-up care is part of this trial?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
WHAT KIND OF PREPARATION SHOULD A POTENTIAL PARTICIPANT MAKE FOR THE MEETING WITH THE RESEARCH COORDINATOR OR DOCTOR?
- Plan ahead and write down your questions.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring a tape recorder to record the discussion so you can replay later.
Every clinical trial in the U.S. 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. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
DOES A PARTICIPANT CONTINUE TO WORK WITH A PRIMARY CARE PROVIDER WHILE IN A TRIAL?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
CAN A PARTICIPANT LEAVE A CLINICAL TRIAL AFTER IT HAS BEGUN?
A participant may leave a clinical trial at any time. When withdrawing from the trial, the participant should alert the research team about the decision 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 experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, its risks and how well it may or may not work.
For more information about clinical trials, please go to http://www.clinicaltrials.gov