Understanding Clinical Research
Frequently Asked Questions
What is a clinical research trial?
Why are clinical trials important?
Where are clinical trials performed?
Who sponsors a clinical trial?
What are the risks of participating in a clinical trial?
What are the benefits of participating in a clinical trial?
What is the study subject expected to do?
What protection does a study subject have in a clinical trial?
Is a subject's study participation and medical information kept confidential?
How does a become a candidate for a clinical trial?
Can subjects be involved in a clinical trial without their knowledge?
Are subjects required to pay for participation in a clinical trial?
Questions to ask before deciding to participate in a clinical trial.
What is a Clinical Research Trial?
A clinical trial is the scientific evaluation of the safety and effectiveness of a new investigational medical treatment, medication or device in human volunteers. After showing benefit in the laboratory, new investigational treatments must be tested in animals and then in small groups of people for safety reasons. Carefully selected doses are then tested in large groups of volunteers to evaluate the safety and effectiveness of the treatment for a specific condition such as diabetes or high blood pressure.
Clinical trials must take place before new research treatments can be made available to the public for prescription or over-the-counter use. Many currently available medical treatments have been analyzed through clinical trials, which are monitored under government regulations.
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Why are clinical trials important?
Clinical trials are important to ensure that after a drug or device is marketed it is a safe and effective treatment for their health conditions, from heart disease to headaches. They provide the means to develop future treatments that are as effective, more effective, or safer than treatments already on the market; they enable researchers to discover new therapeutic uses for currently available medications; and, they make it possible to develop innovative treatments for conditions that currently have no treatment.
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Where are clinical trials performed?
Clinical trials are performed around the world in various settings, including doctors' offices, hospitals, research centers, and teaching institutions such as universities.
Since most trials require periodic visits to the study physician, volunteers should take the location of the facility into consideration when deciding whether or not to participate in a clinical trial.
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Who sponsors a clinical trial?
Most clinical trials are sponsored by pharmaceutical companies, federal health agencies, medical foundations, medical centers, and universities; however, physicians may sponsor some clinical trials, particularly when the trial evaluates a currently available treatment for a condition other than for what it was previously approved. This is a investigational use meanings the U.S. Food and Drug Administration (FDA) has not approved the study drug or device for use.
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What are the risks of participating in a clinical trial?
There are risks to participating in a clinical trial. Although every effort has been made to determine the risks during pre-clinical and early clinical studies, there may be side effects and other health risks that are as of yet unknown. Side effects differ from one person to another, and there is no way to predict how the treatment will affect any given individual. Some of the risks are that subjects may not receive active treatment for their condition and/or the study treatment may not be effective. Sometimes trials require washout periods when subjects have to go off all active treatments for a period of time. The reasonably foreseeable risks of a study are listed in the informed consent form. There may, however, be unforeseen risks and side effects.
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What are the benefits of participating in a clinical trial?
People participate in clinical trials for various reasons, including health, financial, and personal needs. Volunteers who participate in clinical trials may help to further advance medical science, which may help others in the future. While there are no guarantees that participants will benefit from the research treatment they receive, some may find that the study medication relieves their condition more effectively and/or with fewer side effects than their previous treatment plan. Clinical trials sponsored by pharmaceutical companies often provide free study medication and study-related care. In addition, financial compensation for time and travel expenses may be provided to study subjects in some clinical trials.
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What is a placebo?
A placebo is an inactive substance that may be given to a percentage of the study subjects in a clinical trial instead of the active study medication. This is to assist in evaluating the effects of the active study treatment.
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What is informed consent?
Informed consent is the process by which a potential study subject is provided with information about the study and investigational treatment before deciding whether or not to participate in the trial. It includes an explanation of what is involved in the trial, the duration of the study, the frequency and length of the required visits, as well as the known risks and benefits associated with the study treatment.
Participation in a clinical trial is completely voluntary. All questions about the study should be answered to the subject's satisfaction before an informed consent form (ICF) is signed. subjects have the right to refuse participation or to withdraw their consent at any time during the study without penalty.
Throughout the trial, subjects will be provided with any new information that may affect their decision to continue their participation in the study. In addition, the study physician may withdraw a subject at any time, without the subject's consent, if it becomes evident that the treatment is not in the subject's best interest.
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What is the study subject expected to do?
In the interest of safety, the subject must fully inform the study physician about past and current medical conditions, illnesses and medications; follow all instructions of the study staff; and, attend the scheduled visits. Study personnel will explain other, study-specific expectations.
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What protection does a study subject have in a clinical trial?
Clinical trials are governed by ethical and legal guidelines. In 1981, regulations of the Food and Drug Administration made it a requirement that federally regulated clinical trials be reviewed and approved by an Institutional Review Board (IRB) before and during the course of the trial. An IRB is a committee that includes experts and lay people such as doctors, scientists, clergy, and other community members. Their primary goal is to help protect the rights and welfare of the research subjects.
Study plans and the progress of clinical trials are reviewed periodically by the IRB as well as by the study sponsor and the investigator. The IRB must comply with regulations of the FDA, if applicable.
An individual may call the IRB with questions about his or her rights as a research subject. The name and telephone number of the IRB overseeing the clinical trial is included in the informed consent form.
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Is a subject's study participation and medical information kept confidential?
Subject confidentiality is maintained as much as possible during and after a clinical trial. Outside of the research team, a subject's name may not be disclosed without the permission of the subject unless required by law. Generally, the sponsor, FDA, and the IRB have access to the study patient's medical records. To ensure confidentiality, volunteers are assigned a subject number once they are enrolled in a trial and are identified by this number and their initials for the duration of the study.
Subject confidentiality is maintained when the results of a clinical trial are reported to government agencies and in scientific meetings and medical journals.
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How does a person become a candidate for clinical trial?
There are many ways to find out about clinical trials, including advertising, listings on the internet, mailings, word of mouth, health fairs, and physician referrals. Individuals looking for clinical trials for a specific condition should discuss the available options with their physician.
Once a person contacts a research site, the caller will usually have a brief telephone interview to determine if he or she would likely to be a good candidate for the study. A screening visit may then be scheduled for a potential candidate to discuss the trial in more detail and to further screen the candidate for qualification, possibly resulting in study enrollment.
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Can subject's be involved in a clinical trial without their knowledge?
Patients may not be enrolled into clinical trials without their knowledge and written consent.
In the case of children, a parent or legal guardian may provide consent for a child to participate in a clinical trial.
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Are subjects required to pay for participation in a clinical trial?
There is no cost for joining a clinical trial, and study medication as well as study-related tests and procedures are usually provided at no charge to study subjects. It is important to ask the research staff to explain exactly what charges, if any, may be the responsibility of the study subject. Tests and procedures that are part of a person's routine health care may or may not be covered by that person's health insurance plan.
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What questions should you ask before deciding to participate in a clinical trial?
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Why is the clinical trial being conducted?
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What type of study treatment is being provided?
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What are the known side effects of the study treatment?
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How long is the study?
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How often and when will I be expected to come in for visits?
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How long will each visit last?
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How often, when, and how does the study treatment have to be taken?
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When should I call the doctor?
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Who do I contact in case of an emergency?
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Can I continue my current medications?
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What medications do I need to avoid?
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Should I avoid alcohol, specific foods or other agents?
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What procedures are required during the study?
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What effects should I expect from these procedures?
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What other treatment options are available to me, and what advantages or disadvantages could I expect from them?
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Will I be responsible for the cost of any of the visits, medications, or procedures performed during the trial?
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Will my own physician be notified about my participation in the trial?
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How will my study participation affect my daily life?
