Before choosing to participate in a clinical trial, it is often helpful to talk to a physician, family members, or friends. Here are some questions you may have about joining a clinical trial.
Q: How do I find a clinical trial?
A: Your health care provider is a good source for information about clinical trials that may be appropriate for you. A general source for information on clinical trials is http://www.clinicaltrials.gov/, a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and contact information for more details. This information should be used in conjunction with advice from health care professionals. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.
Q: Why should I participate in a clinical trial?
A: Aside from helping others by contributing to medical research, participants in clinical trials gain access to new research treatments before they are widely available and play a more active role in their own health care.
Q: Can I participate in a clinical trial?
A: All clinical trials have guidelines about who can and cannot participate that are based on the objectives of the trial. Participation criteria may be based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Q: What is an "expanded access" protocol?
A: For patients who may benefit from the drug or device use but don't qualify for the trials, FDA regulations enable manufacturers to provide for "expanded access" of an investigational product to people with a life-threatening or serious disease for which there is no effective alternative treatment. Typically, access is expanded only if the studies are well-controlled or completed, if there is evidence that the drug or device may be effective for the patient, and if the risks of the therapy are not unreasonable compared with the severity of the patient's disease. Some investigational drugs are available from pharmaceutical manufacturers through expanded access programs listed at ClinicalTrials.gov.
Q: What's it like participating in a clinical trial?
A: While the process depends on the kind of trial being conducted, there are many common elements. The participant works with a research team that includes doctors and nurses as well as social workers and other health care professionals. This team checks the participant's health at the beginning of the trial, gives specific instructions for participating in the trial, monitors the participant carefully during the trial, and stays in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
Q: What does it mean to give my "informed consent"?
A: Informed consent is the process whereby doctors and nurses involved in the trial explain the details of the study to the potential participants. This process includes an informed consent document that explains risks and potential benefits of the trial and details such as its purpose, duration, required procedures, and key contacts. The consent agreement does not prevent the participant from withdrawing from the trial.
Q: What are the benefits and risks of my participation?
A: Well-designed and well-executed clinical trials can provide benefits to eligible participants that include playing an active role in their own health care, gaining access to new research treatments before they are widely available, obtaining expert medical care at leading health care facilities during the trial, and helping others by contributing to medical research.
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Dr. Samir B. Pancholy, Mercy Hospital and Community Medical Center Scranton, PA, explains the benefits of clinical trials.
Risks posed by clinical trials may include unpleasant, serious, or even life-threatening side effects. Because the drug or device is still being studied, the safety and effectiveness are not yet fully known. In addition, the treatment may not work. Finally, it may take more time and effort than an alternative treatment, such as repeated trips to the study site, more treatments and/or follow up, hospital stays, or complex dosage requirements.
Clinical trial participants are often compensated for their participation. The amount of compensation varies and is usually determined by the trial's time commitment and any physical discomfort that may result from the study.
Q: As a participant, is my safety protected?
A: The same ethical and legal codes that govern medical practice apply to clinical trials. 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 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.
In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. Trials follow a carefully controlled protocol, a study plan that details 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 are confidential.
Q: Do I continue to see a primary health care provider while in a trial?
A: 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.
Q: Can I leave the trial after it's begun?
A: Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
Q: What should I know before agreeing to participate in a trial?
A: Learn as much as possible about the clinical trial and make sure you feel comfortable asking the members of the health care team questions about it, the care you can expect while in a trial, and the cost of participating in the trial. The following questions might be helpful for the participant 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 study?
- Who is going to be in the study?
- 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 study 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?
- What type of long-term follow-up care is part of this study?
- 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?
- What potential conflicts might the researcher or doctor who is running the study have?
- Is the doctor or researcher receiving direct compensation from the institution or company that is funding the study?
Here are some other tips to help make your decision about joining a clinical trial:
- Plan ahead and write down possible questions to ask.
- 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 to replay later.