COMMONLY ASKED QUESTIONS ABOUT CLINICAL TRIALS
What is a clinical trial?
A clinical trial is the last of a long process of testing a new drug, a new procedure, a new treatment or combination of treatments. Drug testing and development are very carefully regulated by the United States government via the Federal Drug Agency (FDA). The search for cures to medical conditions usually starts in a laboratory, where scientists test new ideas on tissue and other samples. This is Phase I. Then promising treatments are tested on animals (Phase II) to see if it has harmful side-effects. If the procedure or drug is not toxic and show real promise, it moves to Phase III where trials are conducted on volunteer patients with the disease in question to see if the drug or procedure is safe and effective. Last, after the drug is licensed and is available to all physicians, clinical trials may be conducted with volunteer patients to find additional uses of the treatment the drug.
Clinical trials are also called clinical studies, research protocols or medical research. They often compare one drug against another to see which is more effective, or they will try the medicine or procedure in a specific demographic group, such as people over 65 or in women, in men with high blood pressure, etc.
Why would I want to participate?
First, everyone benefits when medical science moves forward. Perhaps your participation in a trial will make a significant difference to the health of thousands of other people.
Second, you may be helped personally by being part of a trial that tests a new compound or a new treatment that is not available to the general population. Although this requires more time invested from you, you also receive closer medical attention than if you were not participating in a trial.
Usually your medical visits and procedures are at no cost; occasionally there is a trial payment fee given to the patient for participating. This is to compensate you for the extra time that may be required in additional office visits, or for you to complete required forms.
Important points to remember
- Clinical trials are tests of medical treatments to see if they are safe and if they work.
- Before you agree to take part in a study, you must be given complete information about the study, including possible side-effects and benefits.
- You must sign a special agreement called "Informed Consent" before taking part in the study.
- You can leave the study at any time.
Informed consent protects volunteers
To help you decide if you want to be a volunteer in a study, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. FDA requires that volunteers be told:
- that the study involves research of an unproven drug or device the purpose of the research
- how long the study is expected to take
- what will go on in the study and which parts of the study are experimental
- possible risks or discomforts, possible benefits
- other procedures or treatments that you might want to consider instead of the treatment being studied
- that FDA may inspect study records, but the records will be kept confidential
- whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment
- the person to contact with questions about the study, your rights, and injuries related to research
- being in the study is voluntary and you can quit at any time.
Informed consent information should be written so you can understand it. If you don't, be sure to ask the doctor or other medical person to explain it. Make sure you understand all of it before you agree to be in the study. Before you can participate in the trial, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is NOT a contract and you can leave the study at any time, for any reason.
Phases of drug development
Clinical trials of experimental drugs proceed through four phases:
In Phase I clinical trials, researchers test a new 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 clinical trials, the 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 studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.